OMVOH 300 mg Koncentrat Do Sporządzania Roztworu Infuzyjnego

Treść ulotki

1. Omvoh 300 mg concentrate for solution for infusion
   1. What is Omvoh and what is it used for
   2. What you need to know before you use Omvoh
   3. How to use Omvoh
   4. Possible side effects
   5. How to store Omvoh
   6. Contents of the pack and other information
2. Omvoh 300 mg concentrate for solution for infusion
3. Omvoh 100 mg injectable solution in pre-filled syringe
   1. What is Omvoh and what is it used for
   2. What you need to know before you use Omvoh
   3. How to use Omvoh
   4. Possible side effects
   5. How to store Omvoh
   6. Contents of the pack and other information
4. Omvoh 100 mg injectable solution in pre-filled syringe
5. Omvoh 100 mg injectable solution in pre-filled syringe, 200 mg injectable solution in pre-filled syringe
   1. What is Omvoh and what is it used for
   2. What you need to know before using Omvoh
   3. How to use Omvoh
   4. Possible side effects
   5. How to store Omvoh
   6. Contents of the pack and other information
6. Omvoh 100 mg injectable solution in pre-filled syringe, 200 mg injectable solution in pre-filled syringe
7. Omvoh 100 mg injectable solution in pre-filled pen
   1. What you need to know before you use Omvoh
   2. How to use Omvoh
   3. Possible side effects
   4. How to store Omvoh
   5. Contents of the pack and other information
8. Omvoh 100 mg injectable solution in pre-filled pen
9. Omvoh 100 mg injectable solution in pre-filled pen, 200 mg injectable solution in pre-filled pen
   1. What is Omvoh and what it is used for
   2. What you need to know before you use Omvoh
   3. How to use Omvoh
   4. Possible side effects
   5. How to store Omvoh
   6. Contents of the pack and other information
10. Omvoh 100 mg solution for injection in pre-filled pen, 200 mg solution for injection in pre-filled pen

Omvoh 300 mg concentrate for solution for infusion

mirikizumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
encountered during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Omvoh is and what it is used for
• 2. What you need to know before you use Omvoh
• 3. How to use Omvoh
• 4. Possible side effects
• 5. How to store Omvoh
• 6. Contents of the pack and other information

1. What is Omvoh and what is it used for

Omvoh is used to treat the following inflammatory bowel diseases:

• Ulcerative colitis
• Crohn’s disease

Omvoh contains the active ingredient mirikizumab, a monoclonal antibody. Monoclonal antibodies
are proteins that recognize and specifically bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL 23 (interleukin-23), which is
involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other
symptoms associated with ulcerative colitis and Crohn’s disease.
Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative
colitis, you will first be given other medications. If you do not respond well enough or cannot
tolerate these medications, Omvoh may be given to you to reduce the signs and symptoms of
ulcerative colitis such as diarrhea, abdominal pain, urgency and rectal bleeding.
Crohn’s Disease
Crohn’s disease is a chronic inflammatory disease of the digestive system. If you have active Crohn’s
disease, you will first be given other medications. If you do not respond well enough or
cannot tolerate these medications, Omvoh may be given to you to reduce the signs and symptoms of
Crohn’s disease such as diarrhea, abdominal pain, fatigue and urgency.

2. What you need to know before you use Omvoh

Do not use Omvoh

• If you are allergic to mirikizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh
• if you have significant active infections (active tuberculosis).

Warnings and precautions

• Talk to your doctor or pharmacist before using this medicine.
• The doctor will check your health status before treatment.
• Make sure to inform the doctor about any of your illnesses before starting treatment.

Infections

• Omvoh can potentially cause serious infections.
• Treatment with Omvoh should not be started if you have an active infection until the infection has cleared.
• After starting treatment, immediately inform your doctor if you develop symptoms of an infection such as: o fever o shortness of breath o chills o runny nose o muscle aches o sore throat o cough o pain during urination
• Also, inform your doctor if you have recently been near someone who may have tuberculosis.
• The doctor will examine you and may perform a test for tuberculosis before you take Omvoh.
• If the doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
The doctor will check if vaccinations are necessary before starting treatment. Inform your
doctor, pharmacist or nurse if you have recently received or are about to receive a
vaccination. Some types of vaccines (live vaccines) should not be administered during the use of
Omvoh.

Allergic reactions

• Omvoh can potentially cause severe allergic reactions.
• Stop using Omvoh and get immediate emergency medical attention if you develop any of the following symptoms of a severe allergic reaction: o skin rash o low blood pressure o fainting o swelling of the face, lips, mouth, tongue or throat, difficulty breathing o dizziness o feeling of tightness in the throat o chest tightness.

Liver blood test
The doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check if your liver is functioning normally. If the blood tests are abnormal, the doctor
may stop the therapy with Omvoh and perform further liver tests to determine the
cause.

Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not
been studied in this age group.

Other medicines and Omvoh
Tell your doctor, pharmacist or nurse

• if you are taking, have recently taken or might take any other medicines
• if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for
advice before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh on pregnant women are not known. If you are a woman of childbearing potential, it is advisable
to avoid becoming pregnant and to use effective contraception while using Omvoh and
for at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive and operate machinery.

Omvoh contains sodium
This medicine contains 60 mg of sodium (the main component of table salt) in each
300 mg dose for the treatment of ulcerative colitis. This is equivalent to 3% of the recommended maximum daily intake of salt with the diet for an adult.
This medicine contains 180 mg of sodium (the main component of table salt) in
each 900 mg dose for the treatment of Crohn's disease. This is equivalent to 9% of the recommended daily maximum intake of sodium with the diet for an adult.
Before Omvoh is administered to you, it is mixed with a solution that may contain
sodium. Talk to your doctor if you are on a low-salt diet.

Omvoh contains polysorbate
This medicine contains 0.5 mg/mL of polysorbate 80 in each vial, which is equivalent to 7.5 mg
per induction dose for the treatment of ulcerative colitis and equivalent to 22.5 mg per dose of
induction for the treatment of Crohn's disease. Polysorbates can cause allergic reactions.
Tell your doctor if you have known allergies.

3. How to use Omvoh

Omvoh is intended for use under the guidance and supervision of a physician experienced in the
diagnosis and treatment of ulcerative colitis and Crohn’s disease.

How much Omvoh is given and for how long
The doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term
treatment. The doctor or nurse will regularly monitor your condition to verify that the treatment
has the desired effect.

Ulcerative colitis

• Start of treatment: the first dose of Omvoh is 300 mg and will be administered by the doctor by
  intravenous infusion (drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you
  will receive another dose of Omvoh 300 mg 4 weeks later and again after another 4 weeks.

If you do not obtain an adequate therapeutic response after these 3 infusions, the doctor may
consider continuing the intravenous infusions at weeks 12, 16 and 20.

• Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg
  will be administered by a subcutaneous injection ("under the skin") and then every 4 weeks. The 200 mg
  maintenance dose will be administered by 2 injections each containing 100 mg of Omvoh. If you lose
  response after receiving the Omvoh maintenance dose, the doctor may decide to administer 3 doses of
  Omvoh by intravenous infusion. The doctor or nurse will tell you when to switch to subcutaneous
  injections. During maintenance therapy, you and the doctor or nurse must decide whether you should
  inject Omvoh yourself after training on the subcutaneous injection technique. It is important not to
  attempt to inject the medicine yourself until you have been trained by the doctor or nurse. The doctor or
  nurse will offer the necessary training.

Crohn’s disease

• Start of treatment: the first dose of Omvoh is 900 mg (3 vials of 300 mg each) and will be administered
  by the doctor by intravenous infusion (drip into a vein in the arm) over at least 90 minutes. After the
  first dose, you will receive another dose of Omvoh 900 mg 4 weeks later and again after another 4 weeks.
• Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg
  will be administered by a subcutaneous injection ("under the skin") and then every 4 weeks. The 300 mg
  maintenance dose will be administered with a prefilled syringe or pen of 100 mg and a prefilled syringe
  or pen of 200 mg. The injections can be administered in any order. The 200 mg prefilled syringe or pen
  is intended exclusively for the treatment of Crohn’s disease. The doctor or nurse will tell you when to
  switch to subcutaneous injections. During maintenance therapy, you and the doctor or nurse must decide
  whether you should inject Omvoh yourself after training on the subcutaneous injection technique. It is
  important not to attempt to inject the medicine yourself until you have been trained by the doctor or nurse.
  The doctor or nurse will offer the necessary training.

If you receive more Omvoh than you should
If you have received more Omvoh than you should or the dose has been administered before it was
prescribed, inform the doctor.

If you forget to use Omvoh
Talk to your doctor if you forget a dose of Omvoh.

If you stop using Omvoh
You should not stop using Omvoh without first talking to your doctor. If you stop treatment, the
symptoms of the disease may reappear.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Common(may affect more than 1 in 10 people)

• Reactions at the injection site (e.g. skin redness, pain)

Common(may affect up to 1 in 10 people)

• Upper respiratory tract infections (infections of the nose and throat)
• Joint pain
• Headache
• Skin rash

Uncommon(may affect up to 1 in 100 people)

• Herpes zoster
• Allergic reaction related to infusion (e.g. itching, urticaria)
• Increased level of liver enzymes in the blood

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system detailed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C- 8 °C). Do not freeze.
Keep the vial in the outer packaging to protect it from light.
Do not use this medicine if you notice that the vial is damaged or if the medicine is cloudy,
clearly brown or contains particles.
This medicine is for single use only.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

Diluted solution
It is recommended to start the infusion immediately after dilution. If not used immediately, the
diluted solution prepared with sodium chloride injectable solution 9 mg/mL (0.9 %) may be
stored in a refrigerator (2 ºC – 8 ºC) for no more than 96 hours or at room temperature not exceeding
25 ºC for no more than 10 hours (the total time must not exceed 96 hours) from the time of
vial puncture.
The diluted infusion solution prepared with 5% glucose must be used within 48 hours, of
which no more than 5 hours are allowed at a non-refrigerated temperature not exceeding 25 °C, from the
time of vial puncture.
From a microbiological point of view, the product must be used immediately. If not
used immediately, the storage times and conditions before use are the responsibility of the
user and should normally not exceed 24 hours at 2-8 °C, unless the dilution has been carried out
under controlled and validated aseptic conditions.
Do not dilute the infusion solution with other solutions or co-infuse with other electrolytes or
medicines.
Keep the diluted solution away from direct sources of heat or light.
Do not freeze the diluted solution.

6. Contents of the pack and other information

What Omvoh contains

• The active substance is mirikizumab. Each vial contains 300 mg of mirikizumab in 15 mL (20 mg/mL).
• The other ingredients are sodium citrate dihydrate (E 331); citric acid anhydrous (E 330) sodium chloride, polysorbate 80 (E 433) water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass vial. Its colour may range from colourless to
slightly yellow.
Pack of 1 vial.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia, s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: +371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.
------------------------------------------------------------------------------------------------------------------------

Omvoh 300 mg concentrate for solution for infusion

mirikizumab

The following information is intended for healthcare professionals only:
Do not use Omvoh that has been frozen.
Any unused medicine or waste material must be disposed of in accordance with local
requirements.
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the
administered product must be clearly recorded.
Dilution before intravenous infusion

• 1. Each vial is for single use only.
• 2. Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
• 3. Inspect the contents of the vial. The concentrate should be clear, from colorless to slightly yellow and free of visible particles. Otherwise, it must be discarded.
• 4. Prepare the infusion bag for the treatment of ulcerative colitis or Crohn's disease as specified below. Please note that specific instructions and volumes are specified for each indication.

Ulcerative colitis: one 15 mL vial (300 mg)
Withdraw 15 mL from the vial of mirikizumab (300 mg) using an appropriately sized needle
(18 to 21 gauge is recommended) and transfer it to the infusion bag. If
administered for the treatment of ulcerative colitis, the concentrate must be diluted only in
infusion bags (bag sizes between 50 and 250 mL) containing a
sodium chloride 9 mg/mL (0.9 %) injectable solution or a 5 % glucose injectable solution. The final concentration after dilution is between approximately 1.1 mg/mL and
approximately 4.6 mg/mL.

Crohn's disease: three 15 mL vials; total volume = 45 mL (900 mg)
First, withdraw and discard 45 mL of diluent from the infusion bag.
Then, withdraw 15 mL from each of the three vials of mirikizumab (900 mg)
using a syringe and an appropriately sized needle (18 to 21 gauge is recommended).
If administered for the treatment of Crohn's disease, the concentrate must be diluted
only in infusion bags (bag sizes between 100 and 250 mL) containing
a sodium chloride 9 mg/mL (0.9 %) injectable solution or a 5 % glucose injectable solution.
The final concentration after dilution is between approximately 3.6 mg/mL and approximately 9 mg/mL.

• 5. Gently invert the infusion bag to mix. Do not shake the prepared bag.

Administration of the diluted solution

• 6. The intravenous administration set (infusion line) must be connected to the prepared intravenous bag and the line must be primed. For ulcerative colitis, the infusion must be administered for at least 30 minutes. For Crohn's disease, the infusion must be administered for at least 90 minutes.
• 7. At the end of the infusion, to ensure complete dose delivery, the infusion line must be flushed with a sodium chloride 9 mg/mL (0.9 %) solution or a 5 % glucose injectable solution. The flush must be administered at the same rate used for the administration of Omvoh. The time required to clear the

Omvoh solution from the infusion line is added to the minimum infusion time of
30 minutes (for ulcerative colitis) or 90 minutes (for Crohn's disease).

Omvoh 100 mg injectable solution in pre-filled syringe

mirikizumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Omvoh is and what it is used for
• 2. What you need to know before you use Omvoh
• 3. How to use Omvoh
• 4. Possible side effects
• 5. How to store Omvoh
• 6. Contents of the pack and other information

1. What is Omvoh and what is it used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies
are proteins that recognize and specifically bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL 23 (interleukin-23), which is
involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other
symptoms associated with ulcerative colitis.
Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative
colitis, you will first be given other medicines. If you do not respond well enough or cannot
tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of ulcerative
colitis such as diarrhea, abdominal pain, urgency and rectal bleeding.

2. What you need to know before you use Omvoh

Do not use Omvoh

• If you are allergic to mirikizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh
• if you have significant active infections (active tuberculosis).

Warnings and precautions

• Talk to your doctor or pharmacist before using this medicine.
• The doctor will check your health status before treatment.
• Make sure to inform the doctor about any of your illnesses before starting treatment.

Infections

• Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has disappeared.
• After starting treatment, immediately inform your doctor if you experience symptoms of an infection such as: o fever o shortness of breath o chills o runny nose o muscle aches o sore throat o cough o pain during urination
• Also, inform your doctor if you have recently been near someone who may have tuberculosis.
• The doctor will examine you and may perform a test for tuberculosis before you take Omvoh.
• If the doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
The doctor will check if vaccinations are necessary before starting treatment. Inform your
doctor, pharmacist or nurse if you have recently received or are about to undergo a
vaccination. Some types of vaccines (live vaccines) should not be administered while using
Omvoh.

Allergic reactions

• Omvoh may potentially cause serious allergic reactions.
• Stop using Omvoh and immediately seek emergency medical attention if you develop any of the following symptoms of a severe allergic reaction: o skin rash o low blood pressure o fainting o swelling of the face, lips, mouth, tongue or throat, difficulty breathing o dizziness o feeling of tightness in the throat o chest tightness.

Blood test for the liver
The doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check if your liver is functioning normally. If the blood tests are abnormal, the doctor
may stop therapy with Omvoh and perform further liver tests to determine the
cause.

Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not
been studied in this age group.

Other medicines and Omvoh
Tell your doctor, pharmacist or nurse

• if you are taking, have recently taken or might take any other medicines
• if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for
advice before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh on pregnant women are not known. If you are a woman of childbearing potential, it is advisable
to avoid becoming pregnant and to use effective contraception while using Omvoh and
for at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive vehicles and use machines.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe, which is equivalent to 0.6 mg
per maintenance dose for the treatment of ulcerative colitis. Polysorbates can cause
allergic reactions. Tell your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine following the instructions of your doctor or nurse exactly. If you have any
doubts, consult your doctor, nurse or pharmacist.

How much Omvoh is administered and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term
treatment. Your doctor or nurse will regularly monitor your condition to verify that the
treatment has the desired effect.
Ulcerative Colitis

• Start of treatment: the first dose of Omvoh is 300 mg and will be administered by the doctor via intravenous infusion (drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you will receive another dose of Omvoh 300 mg 4 weeks later and again after another 4 weeks. If you do not obtain an adequate therapeutic response after these 3 infusions, your doctor may consider continuing intravenous infusions at weeks 12, 16 and 20.
• Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be administered via a subcutaneous injection ("subcutaneously") and then every 4 weeks. The maintenance dose of 200 mg will be administered via 2 injections each containing 100 mg of Omvoh. If you lose response after receiving the Omvoh maintenance dose, your doctor may decide to administer 3 doses of Omvoh via intravenous infusion.

Your doctor or nurse will tell you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse must decide whether you should
inject Omvoh yourself after training on the subcutaneous injection technique. It is
important not to attempt to inject the medicine yourself until you have been trained by your
doctor or nurse. Your doctor or nurse will offer the necessary training.
A person who cares for you can also administer your Omvoh injection after
receiving adequate instructions.
Use a method, such as a note on a calendar or diary, to help you
remember the next dose so as to avoid forgetting or repeating the administration
of the medicine.

If you receive more Omvoh than you should
If you have received more Omvoh than you should or the dose has been administered earlier than prescribed,
inform your doctor.

If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Afterwards,
resume administration every 4 weeks.

If you stop using Omvoh
You should not stop using Omvoh without first talking to your doctor. If you stop the
treatment, the symptoms of ulcerative colitis may reappear.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common(may affect more than 1 in 10 people)

• Reactions at the injection site (e.g. skin redness, pain)

Common(may affect up to 1 in 10 people)

• Upper respiratory tract infections (infections of the nose and throat)
• Joint pain
• Headache
• Skin rash

Uncommon(may affect up to 1 in 100 people)

• Herpes zoster
• Allergic reaction related to infusion (e.g. itching, hives)
• Increase in blood level of liver enzymes

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system as detailed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C- 8 °C). Do not freeze.

Donot put the syringes in the microwave, do not run hot water over them or leave them in direct
sunlight.

Donot shake the pre-filled syringe.
Store in the original packaging to protect from light.
Omvoh can be stored non-refrigerated for a maximum of 2 weeks at a temperature not
exceeding 30ºC.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or the medicine is cloudy,
clearly brown or contains particles.
This medicine is for single use only.
Do not dispose of any medicine in wastewater. Ask your doctor, nurse or pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omvoh contains

• The active substance is mirikizumab. Each pre-filled syringe contains 100 mg of mirikizumab in 1 mL of solution.
• The other ingredients are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge enclosed in a single-use syringe. Its
colour may vary from colourless to slightly yellow.
Omvoh is available in packs containing 2 pre-filled syringes and in multiple packs
containing 3 cartons, each with 2 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia, s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība LatvijāTel:

+371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg injectable solution in pre-filled syringe

mirikizumab

2 pre-filled syringes: 1 syringe of 100 mg and 1 syringe of 100 mg

……
Read these instructions before injecting Omvoh. Follow all instructions step by step.

• 2 injections of Omvoh are required for a complete dose for the treatment ofulcerative colitis.
• Inject 1 pre-filled syringe of Omvoh immediately followed by the other pre-filled syringe of Omvoh.

Also keep in mind:

• Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled syringe. Do notinject yourself or someone else until you have been shown how to inject Omvoh.
• Each Omvoh pre-filled syringe is for single use only. Do not share or reuse the syringe. This may transmit or acquire an infection.
• Healthcare professionals can help you decide which part of the body to inject the dose into. You can also read the "Choosing the injection site" section of these instructions to help you choose which area may be best for you.
• If you have vision problems, do not use the Omvoh pre-filled syringe without the help of a caregiver.
• Keep these instructions for use and consult them if necessary.

Before using Omvoh pre-filled syringes, read and follow all instructions step by
step.
Parts of the Omvoh pre-filled syringe
Top Part

Thumb
button
Blue plunger rod
Grip
Gray syringe plunger
Syringe body with the
medicine
Needle
Needle cap
Bottom Part
100 mg+ 100 mg = 1 Complete Dose
IMPORTANT:

• 2 injections are required for a complete dose for the treatment of ulcerative colitis
• Inject one syringe immediately followed by the other syringe.

Preparing your Omvoh injection
Get the syringes from the refrigeratorTake 2 syringes from the refrigerator.

Leave the needle cap on the syringe until you are
ready to give the injection.
Leave the syringes at room temperature for 30 minutes
before starting the injection.

Do notheat the syringes in the microwave, run warm water over them, or leave them in direct sunlight.

Do notuse the syringes if the medicine is frozen.

Do notshake the syringes.

Prepare what you needYou will need:

• 2 alcohol swabs
• 2 cotton balls or gauze pads
• 1 sharps container (see "Disposing of the Omvoh syringe")

Inspect the syringes and the medicineMake sure you have the correct medicine. The medicine
inside should be clear. It may be colorless to slightly yellow.

Do not use the syringeand dispose of it as directed by
healthcare professionals if:

• it looks damaged
• the medicine is cloudy, discolored, or has particles
• the expiration date printed on the label has passed
• the medicine is frozen

Get ready for the injection
Expiration
date

Wash your hands with soap and water before injecting
Omvoh.

Choose the injection siteHealthcare professionals can help you choose the best
injection site for you.

Back of
arm • You or another personcan inject the medicine
into the stomach area (abdomen). Do notinject
within 5 centimeters around the navel.

• You or another personcan inject the medicine into the front of the thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
• Another personcan give you the injection on the back of the arm.
• Do notinject into the exact same spot each time. For example, if the first injection was in the abdomen, the second injection - to deliver a complete dose - could be in another spot on the abdomen.
• Do notinject into areas where the skin is tender, bruised, red, or hardened. Abdomen

Thigh

Clean the injection site with an alcohol swab.
Let the injection site dry before
injecting the medicine.
Injecting Omvoh

Open the syringe

• Leave the needle cap on untilyou are ready for the injection.
• Remove the needle cap and discard it in household waste.
• Do notput the needle cap back on. This could damage the needle or cause you to accidentally injure yourself.
• Do nottouch the needle.

Insert

• Gently pinch and hold the skin where you will give the injection.
• Insert the needle at a 45-degree angle

Inject

• Slowly push the thumb button to push the plunger all the way in until all the medicine has been injected.
• The gray plunger of the syringe must be pushed all the way to the end of the syringe needle.
• When the injection is complete, you should see the blue plunger rod appear through the body of the syringe, as shown.
• Remove the needle from the skin and gently release the skin.
• If there is bleeding at the injection site, press a cotton ball or gauze pad on the injection site.
• Do notrub the injection site.
• Do notput the needle cap back on the pre-filled syringe .

Blue plunger rod
Gray syringe
plunger

2 injections are needed for a complete dose. Inject one syringe immediately
followed by the other syringe.
Disposing of the Omvoh syringe
Throw away the used syringe

• Place the used syringe in a sharps container immediately after use. Do not throw the syringe directly into household waste.
• If you do not have a sharps container, you can use a household container that:
• is made of durable plastic
• can be closed with a tight, puncture-resistant lid that does not allow sharp objects to leak out
• is upright and stable during use
• is leak-proof
• is properly labeled to warn of the presence of hazardous waste inside the container.
• When the sharps container is almost full, you will need to follow community guidelines for the proper way to dispose of the sharps container. There may be local laws about how to throw away needles and syringes.
• Do not recycle the used sharps container.
• For more information on how to properly dispose of the container, ask healthcare professionals about the options available in your area.

Frequently Asked Questions

• Q. What happens if I let my syringe warm up for more than 30 minutes before the injection?
• A.The syringe can remain at room temperature up to 30°C for up to 2 weeks.
• Q. What happens if I see air bubbles in my syringe?
• A.It is normal to have air bubbles in the syringe. They are not dangerous and will not affect the dose.
• Q. What happens if there is a drop of liquid on the tip of the needle when I remove theneedle cap?
• A.It is okay to see a drop of liquid on the tip of the needle. This is not dangerous and will not affect the dose.
• Q. What happens if I can't push the plunger?
• A.If the plunger is stuck or damaged:
• Do notcontinue to use the syringe
• Remove the needle from the skin
• Do not use the syringe. Talk to your doctor or pharmacist for a new one.
• Q.What happens if there is a drop of liquid or blood on the skin after the injection?
• A.This is normal. Press a cotton ball or gauze pad on the injection site. Do notrub the injection site.

• Q.How will I know when my injection is complete?
• A.When the injection is complete:
• The blue plunger rod must be visible through the body of the syringe.
• The gray plunger of the syringe must be pushed all the way to the end of the syringe needle.

for more information about this medicine.

Omvoh 100 mg injectable solution in pre-filled syringe, 200 mg injectable solution in pre-filled syringe

mirikizumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Omvoh is and what it is used for
• 2. What you need to know before you use Omvoh
• 3. How to use Omvoh
• 4. Possible side effects
• 5. How to store Omvoh
• 6. Contents of the pack and other information

1. What is Omvoh and what is it used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and specifically bind to certain
target proteins in the body. Omvoh works by binding to and blocking a protein in the body called IL-
23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces
inflammation and other symptoms associated with Crohn's disease.
Crohn’s Disease
Crohn's disease is a chronic inflammatory disease of the digestive system. If you have
active Crohn's disease, you will first be given other medicines. If you do not respond well enough
or cannot tolerate these medicines, you may be given Omvoh to reduce the signs and
symptoms of Crohn's disease such as diarrhea, abdominal pain, fatigue and urgency.

2. What you need to know before using Omvoh

Do not use Omvoh

• If you are allergic to mirikizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
• if you have significant active infections (active tuberculosis).

Warnings and precautions

• Talk to your doctor or pharmacist before using this medicine.
• The doctor will check your health status before treatment.
• Make sure to inform the doctor about any of your illnesses before starting treatment.

Infections

• Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has cleared.
• After starting treatment, immediately inform your doctor if you experience symptoms of an infection such as: o fever o shortness of breath o chills o runny nose o muscle aches o sore throat o cough o pain during urination
• Also, inform your doctor if you have recently been near someone who may have tuberculosis.
• The doctor will examine you and may perform a test for tuberculosis before you take Omvoh.
• If the doctor believes you are at risk of active tuberculosis, they may prescribe you medication to treat it.

Vaccinations
The doctor will check if vaccinations are necessary before starting treatment. Inform your
doctor, pharmacist or nurse if you have recently received or are about to receive a
vaccination. Some types of vaccines (live vaccines) should not be administered while using
Omvoh.

Allergic reactions

• Omvoh may potentially cause serious allergic reactions.
• Stop using Omvoh and immediately seek emergency medical attention if you develop any of the following symptoms of a serious allergic reaction: o skin rash o low blood pressure o fainting o swelling of the face, lips, mouth, tongue or throat, difficulty breathing o dizziness o feeling of tightness in the throat o chest tightness.

Blood test for the liver
The doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check if your liver is functioning normally. If the blood tests are abnormal, the doctor
may stop therapy with Omvoh and perform further liver tests to determine the
cause.

Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not
been studied in this age group.

Other medicines and Omvoh
Tell your doctor, pharmacist or nurse

• if you are taking, have recently taken or might take any other medicines
• if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for
advice before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh on pregnant women are unknown. If you are a woman of childbearing potential, it is advisable
to avoid becoming pregnant and to use effective contraception while using Omvoh and
for at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive and use machines.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe, which is equivalent to 0.9 mg
for the maintenance dose for the treatment of Crohn's disease. Polysorbates can cause
allergic reactions. Tell your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine following the instructions of your doctor or nurse exactly. If you have
any doubts, consult your doctor, nurse or pharmacist.

How much Omvoh is administered and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term
treatment. Your doctor or nurse will regularly monitor your condition to verify
that the treatment has the desired effect.
Crohn’s Disease

• Start of treatment: the first dose of Omvoh is 900 mg (3 vials of 300 mg each) and will be administered by the doctor via intravenous infusion (drip into a vein in the arm) lasting at least 90 minutes. After the first dose, you will receive another dose of Omvoh 900 mg 4 weeks later and again after another 4 weeks.
• Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be administered by subcutaneous injection ("under the skin") and subsequently every 4 weeks. The maintenance dose of 300 mg will be administered with 2 injections, one containing 100 mg (1 mL) of Omvoh and one containing 200 mg (2 mL) of Omvoh. The injections can be administered in any order. The prefilled 200 mg syringe is intended exclusively for the treatment of Crohn’s disease.

Your doctor or nurse will tell you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse must decide whether you should
inject Omvoh yourself after training on the subcutaneous injection technique. It is
important not to attempt to inject the medicine yourself until you have been trained by
your doctor or nurse. Your doctor or nurse will offer the necessary training.
A person who cares for you can also administer the Omvoh injection after
receiving adequate instructions.
Use a method, such as a note on a calendar or diary, to help you
remember the next dose so as to avoid forgetting or repeating the administration
of the medicine.

If you receive more Omvoh than you should
If you have received more Omvoh than you should or the dose has been administered earlier than prescribed,
inform your doctor.

If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Afterwards,
resume administration every 4 weeks.

If you stop using Omvoh
You should not stop using Omvoh without first talking to your doctor. If you stop the
treatment, the symptoms of ulcerative colitis may reappear.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Common(may affect more than 1 in 10 people)

• Reactions at the injection site (e.g. skin redness, pain)

Common(may affect up to 1 in 10 people)

• Upper respiratory tract infections (infections of the nose and throat)
• Joint pain
• Headache
• Skin rash

Uncommon(may affect up to 1 in 100 people)

• Herpes zoster
• Allergic reaction related to infusion (e.g. itching, hives)
• Increased level of liver enzymes in the blood

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system as described in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C- 8 °C). Do not freeze.

Donot put the syringes in the microwave, do not run hot water over them or leave them in direct
sunlight.

Donot shake the pre-filled syringe.
Store in the original packaging to protect it from light.
Omvoh can be stored unrefrigerated for a maximum of 2 weeks at a temperature not
exceeding 30ºC.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or the medicine is cloudy,
clearly brown or contains particles.
This medicine is for single use only.
Do not dispose of any medicine in wastewater. Ask your doctor, nurse or pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omvoh contains

• The active substance is mirikizumab. A prefilled syringe contains 100 mg of mirikizumab in 1 mL of solution and a prefilled syringe contains 200 mg of mirikizumab in 2 mL of solution.
• The other ingredients are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge enclosed in a single-use syringe. Its
color may vary from colorless to slightly yellow.
Omvoh is available in packs containing 2 prefilled syringes and in multiple packs
containing 3 cartons, each with 2 prefilled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia, s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība LatvijāTel:

+371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg injectable solution in pre-filled syringe, 200 mg injectable solution in pre-filled syringe

mirikizumab

2 pre-filled syringes: 1 syringe of 100 mg and 1 syringe of 200 mg

Read these instructions before injecting Omvoh. Follow all instructions step by step.

• For a complete dose, 2 Omvoh injections are required for the treatment ofCrohn's disease: one 100 mg syringe and one 200 mg syringe.
• Inject 1 pre-filled syringe of Omvoh immediately followed by the other pre-filled syringe of Omvoh.

Also keep in mind:

• Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled syringe. Do notinject yourself or someone else until you have been shown how to inject Omvoh.
• Each Omvoh pre-filled syringe is for single use only. Do not share or reuse the syringe. It may transmit or cause an infection.
• Healthcare professionals can help you decide where on your body to inject the dose. You can also read the "Choosing the injection site" section of these instructions to help you choose which area might be best for you.
• If you have vision problems, do not use the Omvoh pre-filled syringe without the help of a caregiver.
• Keep these instructions for use and refer to them if needed.

Before using Omvoh pre-filled syringes, read and carefully follow all instructions
step by step.
2 syringes = complete 300 mg dose
After the first injection, choosea new injection site at least 5 centimeters away and
clean it. With the second syringe, repeat steps 1-3immediately after the first injection.

You must inject 2 syringes to complete the entire 300 mg dose.
Parts of the Omvoh pre-filled syringe
Inject both syringes in any order for a complete 300 mg dose.
The 200 mg syringe is larger than the 100 mg syringe.

Thumb
button
Blue
plunger rod
Top
Grip
Gray syringe
plunger
Syringe body with
medicine
Needle
Needle cap
Bottom
100 mg + 200 mg = 1 Complete Dose
IMPORTANT:

• For a complete dose, 2 injections are required for the treatment of Crohn's disease: one syringe with 100 mg and one syringe with 200 mg
• Inject one syringe immediately followed by the other syringe.

Preparing your Omvoh injection
Take the syringes from the refrigeratorTake 2 syringes from the refrigerator.

Leave the needle cap on the syringe until you are
ready to give the injection.
Leave the syringes at room temperature for 45 minutes
before starting the injection.

Do notheat the syringes in the microwave, run warm water over them, or leave them in direct sunlight.

Do notuse the syringes if the medicine is frozen.

Do notshake the syringes.

Prepare what you needYou will need:

• 2 alcohol swabs
• 2 cotton balls or gauze pads
• 1 sharps container (see "Disposing of the Omvoh syringe")

Inspect the syringes and the medicineMake sure you have the correct medicine. The medicine
inside should be clear. It may be colorless to
light yellow.

Do not use the syringeand dispose of it as directed by
healthcare professionals if:

• it looks damaged
• the medicine is cloudy, discolored, or has particles
• the expiration date printed on the label has passed
• the medicine is frozen

Get ready to inject
Expiration
date

Wash your hands with soap and water before injecting
Omvoh.

Choose the injection siteHealthcare professionals can help you choose the best
injection site for you.

• You or another personcan inject the medicine into the area of the stomach (abdomen). Do notinject within 5 centimeters around the navel.
• You or another personcan inject the medicine into the front of your thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
• Another personcan give you an injection in the back of your arm.
• Do notinject in the same exact spot every time. For example, if the first injection was in the abdomen, the second injection - to complete a dose - could be in another spot on the abdomen.
• Do notinject into areas where the skin is tender, bruised, red, or hardened.

You or another person
can inject the
medicine into these
areas
In this area another
person must
inject

Clean the injection site with an alcohol swab.
Let the injection site dry before
injecting the medicine.
Injecting Omvoh

Open the syringe

• Leave the needle cap on until you are ready for the injection.
• Remove the needle cap and discard it in the household trash.
• Do notput the needle cap back on. You could damage the needle or accidentally injure yourself.
• Do nottouch the needle.

Insert

• Gently pinch and hold the skin where you will give the injection.
• Insert the needle at a 45-degree angle

Inject

• Slowly push the thumb button to push the plunger all the way in until all the medicine is injected.
• The gray plunger of the syringe must be pushed all the way to the end of the needle of the syringe.
• When the injection is complete, you should see the blue plunger rod appear through the body of the syringe, as shown.
• Remove the needle from the skin and gently release the skin.
• If there is bleeding at the injection site, press a cotton ball or gauze pad on the injection site.
• Do notrub the injection site.
• Do notput the needle cap back on the pre-filled syringe.

Blue plunger rod
Gray syringe
plunger

You need 2 injections for a complete dose. Inject one syringe immediately followed
by the other syringe.
Disposing of the Omvoh syringe
Throw away the used syringe

• Place the used syringe in a sharps container immediately after use. Do not throw the syringe directly into the household trash.
• If you do not have a sharps container, you can use a household container that:
• is made of durable plastic
• can be closed with a tight-fitting, puncture-resistant lid that will not allow objects to leak out
• is upright and stable during use
• is leak-proof
• is properly labeled to warn of hazardous waste inside the container.
• When the sharps container is almost full, you will need to follow community guidelines for the proper way to dispose of the sharps container. There may be local laws about how to throw away needles and syringes.
• Do not recycle the used sharps container.
• For more information on how to properly dispose of the container, ask healthcare professionals about the options available in your area.

Frequently Asked Questions

• Q. What happens if I let my syringe warm up for more than 45 minutes before the injection?
• A.The syringe can remain at room temperature up to 30°°C for up to 2 weeks.
• Q. What happens if I see air bubbles in my syringe?
• A.It is normal to have air bubbles in the syringe. They are not harmful and will not affect the dose.
• Q. What happens if there is a drop of liquid on the tip of the needle when I remove theneedle cap?
• A.It is okay to see a drop of liquid on the tip of the needle. This is not harmful and will not affect the dose.
• Q. What happens if I can’t push the plunger?
• A.If the plunger is stuck or damaged:
• Do notcontinue to use the syringe
• Remove the needle from the skin
• Do not use the syringe. Talk to your doctor or pharmacist for a new one.

• Q.What happens if there is a drop of liquid or blood on the skin after the injection?
• A.This is normal. Press a cotton ball or gauze pad on the injection site. Do notrub the injection site.
• Q.How will I know when my injection is complete?
• A.When the injection is complete:
• The blue plunger rod must be visible through the body of the syringe.
• The gray plunger of the syringe must be pushed all the way to the end of the needle of the syringe.

for more information about this medicine.

Omvoh 100 mg injectable solution in pre-filled pen

mirikizumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Omvoh is and what it is used for
• 2. What you need to know before you use Omvoh
• 3. How to use Omvoh
• 4. Possible side effects
• 5. How to store Omvoh
• 6. Contents of the pack and other information
• 1.WhatOmvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies
are proteins that recognize and specifically bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is
involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other
symptoms associated with ulcerative colitis.
Ulcerative colitis
Ulcerative colitis is a chronic inflammatory bowel disease. If you have ulcerative
colitis, you will first be given other medicines. If you do not respond well enough or cannot
tolerate these medicines, you may be given Omvoh to reduce the signs and symptoms of
ulcerative colitis such as diarrhoea, abdominal pain, urgency and rectal bleeding.

2. What you need to know before you use Omvoh

Do not use Omvoh

• If you are allergic to mirikizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh
• if you have significant active infections (active tuberculosis).

Warnings and precautions

• Talk to your doctor or pharmacist before using this medicine.
• The doctor will check your health status before treatment.
• Make sure to inform the doctor about any of your illnesses before starting treatment.

Infections

• Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has cleared.
• After starting treatment, immediately inform your doctor if you experience symptoms of an infection such as: o fever o shortness of breath o chills o runny nose o muscle aches o sore throat o cough o pain during urination
• Also, inform your doctor if you have recently been near someone who may have tuberculosis.
• The doctor will examine you and may perform a test for tuberculosis before you take Omvoh.
• If the doctor believes that you are at risk of active tuberculosis, they may prescribe medicines to treat it.

Vaccinations
The doctor will check if vaccinations are necessary before starting treatment. Inform your
doctor, pharmacist or nurse if you have recently received or are about to receive a
vaccination. Some types of vaccines (live vaccines) should not be administered during the use of
Omvoh.

Allergic reactions

• Omvoh may potentially cause serious allergic reactions.
• Stop using Omvoh and immediately seek emergency medical attention if you develop any of the following symptoms of a serious allergic reaction: o skin rash o low blood pressure o fainting o swelling of the face, lips, mouth, tongue or throat, difficulty breathing o dizziness o feeling of tightness in the throat o chest tightness.

Blood test for the liver
The doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check if your liver is functioning normally. If the blood tests are abnormal, the doctor
may stop therapy with Omvoh and perform further liver tests to determine the
cause.

Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not
been studied in this age group.

Other medicines and Omvoh
Tell your doctor, pharmacist or nurse

• if you are taking, have recently taken or might take any other medicines
• if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for
advice before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh on pregnant women are not known. If you are a woman of childbearing potential, it is advisable
to avoid becoming pregnant and to use effective contraception while using Omvoh and
for at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive and use machines.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each vial, which is equivalent to 0.6 mg
per induction dose for the treatment of ulcerative colitis. Polysorbates can cause allergic
reactions. Tell your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine following the instructions of your doctor or nurse exactly. If you have any
doubts, ask your doctor, nurse or pharmacist.

How much Omvoh is given and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term
treatment. Your doctor or nurse will regularly monitor your condition to check that the
treatment has the desired effect.
Ulcerative colitis

• Start of treatment: the first dose of Omvoh is 300 mg and will be given by your doctor by intravenous infusion (drip into a vein in your arm) lasting at least 30 minutes. After the first dose, you will receive another dose of Omvoh 300 mg 4 weeks later and again after another 4 weeks. If you do not get an adequate therapeutic response after these 3 infusions, your doctor may consider continuing the intravenous infusions at weeks 12, 16 and 20.
• Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be given by a subcutaneous injection ("under the skin") and then every 4 weeks. The maintenance dose of 200 mg will be given by 2 injections each containing 100 mg of Omvoh. If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to give you 3 doses of Omvoh by intravenous infusion.

Your doctor or nurse will tell you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse must decide whether you should
inject Omvoh yourself after training on the subcutaneous injection technique. It is
important not to attempt to inject the medicine yourself until you have been trained by your
doctor or nurse. Your doctor or nurse will provide the necessary training.
Someone who cares for you can also give you the Omvoh injection after
they have received adequate instructions.
Use a method, such as a note on a calendar or diary, to help you
remember the next dose so as to avoid forgetting or repeating the administration
of the medicine.

If you receive more Omvoh than you should
If you have received more Omvoh than you should or the dose has been given earlier than prescribed,
tell your doctor.

If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Afterwards,
resume administration every 4 weeks.

If you stop using Omvoh
You should not stop using Omvoh without talking to your doctor first. If you stop the
treatment, the symptoms of ulcerative colitis may return.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Common(may affect more than 1 in 10 people)

• Reactions at the injection site (e.g. skin redness, pain)

Common(may affect up to 1 in 10 people)

• Upper respiratory tract infections (infections of the nose and throat)
• Joint pain
• Headache
• Skin rash

Uncommon(may affect up to 1 in 100 people)

• Herpes zoster
• Allergic reaction related to infusion (e.g. itching, hives)
• Increase in blood level of liver enzymes

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system as indicated in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C- 8 °C). Do not freeze.

Donot put the pens in the microwave, do not run hot water over them or leave them in direct
sunlight.

Donot shake the pre-filled pen.
Store in the original packaging to protect it from light.
Omvoh can be stored unrefrigerated for a maximum of 2 weeks at a temperature not
exceeding 30ºC.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled pen is damaged, or the medicine is cloudy,
clearly brown or contains particles.
This medicine is for single use only.
Do not dispose of any medicine in wastewater. Ask your doctor, nurse or pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omvoh contains

• The active substance is mirikizumab. Each pre-filled pen contains 100 mg of mirikizumab in 1 mL of solution.
• The other ingredients are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge enclosed in a disposable
single-use pen. Its colour may range from colourless to slightly yellow.
Omvoh is available in packs of 2 pre-filled pens, in multiple packs of 2 packs,
each containing 2 pre-filled pens and in multiple packs of 3 packs, each containing
2 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia, s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība
LatvijāLatvijā
Tel: +371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg injectable solution in pre-filled pen

mirikizumab
2 pre-filled pens: 1 pen of 100 mg and 1 pen of 100 mg

Read these instructions before injecting Omvoh. Follow all instructions step by step.

• 2 Omvoh injections are required for a complete dose for the treatment ofulcerative colitis.
• Inject 1 Omvoh pen immediately followed by the other Omvoh pen.

Also keep in mind:

• Healthcare professionals must show you how to prepare and inject Omvoh using the pen. Do notinject yourself or someone else until you have been shown how to inject Omvoh.
• Each Omvoh pen is for single use only. Do not share or reuse the pen. You could transmit or contract an infection.
• Healthcare professionals can help you decide which part of the body to inject the dose into. You can also read the "Choosing the injection site" section of these instructions to help you choose which area may be best for you.
• If you have vision or hearing problems, do not use the Omvoh pre-filled pen without the help of a caregiver.
• Keep these instructions for use and consult them if necessary.

Before using Omvoh pre-filled pens, read and follow all instructions step by
step.
Parts of the Omvoh pen
Top Part

Blue injection button
Locking ring
Lock/unlock
symbols
Medicine
Needle
Transparent base
Gray cap of the
base
Bottom Part
100 mg + 100 mg = 1 Complete Dose
IMPORTANT:

• 2 injections are required for a complete dose for the treatment of ulcerative colitis
• Inject 1 pen immediately followed by the other pen. Medicine

Preparing the Omvoh injection
Take the pens out of the refrigeratorTake 2 pens out of the refrigerator.

Leave the gray cap of the base on until you are
ready for the injection.
Leave the pens at room temperature for 30 minutes
before starting the injection.

Do notheat the pens in the microwave, run warm water over them, or leave them in direct sunlight.

Do notuse the pens if the medicine is frozen.

Do notshake the pens.

Prepare what you needYou will need:

• 2 alcohol-soaked wipes
• 2 cotton balls or gauze pads
• 1 sharps container (see "Disposing of Omvoh pens")

Inspect the pen and the medicineMake sure you have the correct medicine. The medicine
inside should be clear. It may be colorless to
light yellow.

Do not use the pensand dispose of them as directed by healthcare
professionals if:

• they appear damaged
• the medicine is cloudy, discolored, or has particles
• the expiration date printed on the label has passed
• the medicine is frozen

Prepare for the injection
Expiration
date

Wash your hands with soap and water before injecting
Omvoh.

Choose the injection siteHealthcare professionals can help you choose the most
suitable injection site for you.

Back of
the arm

• You or another personcan inject the medicine into the abdominal area (stomach). Do notinject within 5 centimeters around the navel.
• You or another personcan inject the medicine into the front of the thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
• Another personcan inject you in the back of the arm.
• Do notinject into the exact same spot every time. For example, if the first injection was in the abdomen, the second injection, to deliver a complete dose, could be in another area of the abdomen.
• Do notinject into areas where the skin is sensitive, bruised, red, or hardened.

Clean the injection site with an alcohol-soaked
wipe. Let the injection site dry before
injecting the medicine.
Abdomen
Thigh

Injecting Omvoh
1 Remove the cap from the pen

Make sure the pen islocked.
Leave the gray cap of the base on until
you are ready for the injection.

• Unscrew the gray cap at the base and discard it in household waste.
• Do notput the gray cap back on the base
• this could damage the needle.
• Do nottouch the needle.

2 Position and unlock

• Position and hold the transparent base flat and firmly against the skin.

Hold the base against the skin and rotate
the locking ring to the

unlockposition.

3 Press and hold for a

maximum of 10 seconds10

• Press and hold the blue injection button. You will feel a strong click (injection started).
• Continue to hold thetransparent base firmly against the skin.You will feel a second strong click about 10 seconds after the first (injection completed).

• You will know the injection is complete when the gray plunger is visible.
• Remove the pen from the skin.
• If bleeding occurs at the injection site, press a cotton ball or gauze pad on the injection site.
• Do notrub the injection site.

2 injections are needed for a complete dose. Inject one pen immediately
followed by the other pen.
Disposing of Omvoh pens
Throw away the used pens

• Place the used pen in a sharps container immediately after use. Do not throw the pen directly into household waste.
• If you do not have a sharps container, you can use a household container that:
• is made of durable plastic
• can be closed with a tight-fitting, puncture-resistant lid, without any sharp objects protruding
• is upright and stable during use
• is leak-proof
• is properly labeled to warn of the presence of hazardous waste inside the container.
• When the sharps container is almost full, you will need to follow community guidelines for the proper way to dispose of the sharps container. There may be local laws on how to throw away needles and pens.
• Do not recycle the used sharps container.
• For more information on how to properly dispose of the container, ask your doctor about the options available in your area.

Frequently Asked Questions

• Q. What happens if I let my pen warm up for more than 30 minutes before injecting?
• A.The pen can remain at room temperature up to 30°C for up to 2 weeks.
• Q. What happens if I see air bubbles in my pen?
• A.It is normal to have air bubbles in the pen. They are not dangerous or will affect the dose.
• Q. What happens if I see a drop of liquid on the tip of the needle when I remove the gray base cap?
• A.It is okay to see a drop of liquid on the tip of the needle. This will not harm or affect your dose.
• Q. What happens if I unlock the pen and press the blue injection button until the injection is complete?
• A. Do notremove the gray cap of the base. Do not use the pen. Talk to your doctor or pharmacist to get a new one.
• Q. Do I have to keep pressing the blue injection button until the injection is complete?
• A.You do not need to keep pressing the blue injection button, but it can help keep the pen stable and firm against the skin.
• Q. What happens if the needle does not retract after the injection?
• A. Do nottouch the needle or replace the gray cap of the base. Keep the pen in a safe place to avoid accidental punctures and contact your doctor, pharmacist, or nurse.
• Q. What happens if there is a drop of liquid or blood on the skin after the injection?
• A.This is normal. Press a cotton ball or gauze pad on the injection site. Do notrub the injection site.
• Q. What happens if I heard more than 2 clicks during the injection: 2 strong clicks and one weak click. Have I received the complete injection?
• A.Some patients may hear a slight click just before the second strong click. This is the normal operation of the pen. Do notremove the pen from the skin until you hear the second strong click.
• Q. How can I tell if my injection is complete?
• A.After pressing the blue injection button, you will hear 2 strong clicks. The second strong click indicates that the injection is complete. You will also see the gray plunger in the top part of the transparent base.

more information about this medicine.

Omvoh 100 mg injectable solution in pre-filled pen, 200 mg injectable solution in pre-filled pen

mirikizumab
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Omvoh is and what it is used for
• 2. What you need to know before you use Omvoh
• 3. How to use Omvoh
• 4. Possible side effects
• 5. How to store Omvoh
• 6. Contents of the pack and other information

1. What is Omvoh and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and specifically bind to certain
target proteins in the body. Omvoh works by binding to and blocking a protein in the body called IL
23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces
inflammation and other symptoms associated with Crohn's disease.
Crohn’s Disease
Crohn's disease is a chronic inflammatory disease of the digestive system. If you have
active Crohn's disease, you will first be given other medicines. If you do not respond well enough
or cannot tolerate these medicines, you may be given Omvoh to reduce the signs and
symptoms of Crohn's disease such as diarrhea, abdominal pain, fatigue and urgency.

2. What you need to know before you use Omvoh

Do not use Omvoh

• If you are allergic to mirikizumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh
• if you have significant active infections (active tuberculosis).

Warnings and precautions

• Talk to your doctor or pharmacist before using this medicine.
• The doctor will check your health status before treatment.
• Make sure to inform the doctor about any of your illnesses before starting treatment.

Infections

• Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has cleared.
• After starting treatment, immediately inform your doctor if you experience symptoms of an infection such as: o fever o shortness of breath o chills o runny nose o muscle aches o sore throat o cough o pain during urination
• Also inform your doctor if you have recently been near someone who may have tuberculosis.
• The doctor will examine you and may perform a test for tuberculosis before you take Omvoh.
• If the doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
The doctor will check if vaccinations are necessary before starting treatment. Inform your
doctor, pharmacist or nurse if you have recently received or are about to receive a
vaccination. Some types of vaccines (live vaccines) should not be administered while using
Omvoh.

Allergic reactions

• Omvoh may potentially cause serious allergic reactions.
• Stop using Omvoh and immediately seek emergency medical attention if you develop any of the following symptoms of a serious allergic reaction: o skin rash o low blood pressure o fainting o swelling of the face, lips, mouth, tongue or throat, difficulty breathing o dizziness o feeling of tightness in the throat o chest tightness.

Liver blood test
The doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check if your liver is functioning normally. If the blood tests are abnormal, the doctor
may stop therapy with Omvoh and perform further liver tests to determine the
cause.

Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not
been studied in this age group.

Other medicines and Omvoh
Tell your doctor, pharmacist or nurse

• if you are taking, have recently taken or might take any other medicines
• if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for
advice before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh on pregnant women are unknown. If you are a woman of childbearing potential, it is advisable
to avoid becoming pregnant and to use effective contraception while using Omvoh and
for at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive and operate machinery.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe, which is equivalent to 0.9 mg
per maintenance dose for the treatment of Crohn’s disease. Polysorbates can cause
allergic reactions. Tell your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine following the instructions of your doctor or nurse exactly. If you have
any doubts, ask your doctor, nurse or pharmacist.

How much Omvoh is given and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term
treatment. Your doctor or nurse will regularly monitor your condition to ensure
that the treatment has the desired effect.
Crohn’s Disease

• Start of treatment: the first dose of Omvoh is 900 mg (3 vials of 300 mg each) and will be given by your doctor by intravenous infusion (drip into a vein in your arm) lasting at least 90 minutes. After the first dose, you will receive another dose of Omvoh 900 mg 4 weeks later and again after another 4 weeks.
• Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be given by a subcutaneous injection ("under the skin") and then every 4 weeks. The maintenance dose of 300 mg will be given by 2 injections, one containing 100 mg (1 mL) of Omvoh and one containing 200 mg (2 mL) of Omvoh. The injections can be given in any order. The prefilled 200 mg syringe is only for the treatment of Crohn’s disease.

Your doctor or nurse will tell you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse must decide whether you should
inject Omvoh yourself after training on the subcutaneous injection technique. It is
important not to attempt to inject the medicine yourself until you have been trained by
your doctor or nurse. Your doctor or nurse will offer the necessary training.
A person who cares for you can also give you the Omvoh injection after
receiving adequate instructions.
Use a method, such as a note on a calendar or diary, to help you
remember the next dose so as to avoid forgetting or repeating the administration
of the medicine.

If you receive more Omvoh than you should
If you have received more Omvoh than you should or the dose has been given earlier than prescribed,
tell your doctor.

If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Afterwards,
resume administration every 4 weeks.

If you stop using Omvoh
You should not stop using Omvoh without talking to your doctor first. If you stop
treatment, the symptoms of ulcerative colitis may return.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Common(may affect more than 1 in 10 people)

• Reactions at the injection site (e.g. skin redness, pain)

Common(may affect up to 1 in 10 people)

• Upper respiratory tract infections (infections of the nose and throat)
• Joint pain
• Headache
• Skin rash

Uncommon(may affect up to 1 in 100 people)

• Herpes zoster
• Allergic reaction related to infusion (e.g. itching, urticaria)
• Increase in blood level of liver enzymes

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“EXP.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C- 8 °C). Do not freeze.

Donot put the syringes in the microwave, do not run hot water over them or leave them in direct
sunlight.

Donot shake the pre-filled syringe.
Store in the original packaging to protect from light.
Omvoh can be stored non-refrigerated for a maximum of 2 weeks at a temperature not
exceeding 30ºC.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or the medicine is cloudy,
clearly brown or contains particles.
This medicine is for single use only.
Do not dispose of any medicine in wastewater. Ask your doctor, nurse or pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omvoh contains

• The active substance is mirikizumab. A prefilled syringe contains 100 mg of mirikizumab in 1 mL of solution and a prefilled syringe contains 200 mg of mirikizumab in 2 mL of solution.
• The other ingredients are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge enclosed in a single-use pen. Its
colour may range from colourless to slightly yellow.
Omvoh is available in packs containing 2 prefilled pens and in multiple packs containing
3 packs, each with 2 prefilled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia, s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība LatvijāTel:

+371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg solution for injection in pre-filled pen, 200 mg solution for injection in pre-filled pen

mirikizumab

2 pre-filled pens: 1 pen from 100 mg and 1 pen from 200 mg

Read these instructions before injecting Omvoh. Follow all instructions step by step.

• 2 Omvoh injections are required for a complete dose for the treatment ofCrohn's disease: one 100 mg pen and one 200 mg pen.
• Inject 1 pre-filled Omvoh pen immediately followed by the other pre-filled Omvoh pen.

Also keep in mind:

• Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled pen. Do notinject yourself or someone else until you have been shown how to inject Omvoh.
• Each pre-filled Omvoh pen is for single use only. Do not share or reuse the pen. This may transmit or acquire an infection.
• Healthcare professionals can help you decide which part of the body to inject the dose into. You can also read the "Choosing the injection site" section of these instructions to help you choose which area may be best for you.
• If you have vision problems, do not use the Omvoh pre-filled pen without the help of a caregiver.
• Keep these instructions for use and consult them if necessary.

Before using Omvoh pre-filled pens, read and carefully follow all instructions step by
step.
2 pens = complete 300 mg dose
After the first injection, choosea new injection site at least 5 centimeters away and
clean it. With the second syringe, repeat steps 1-3immediately after the first injection.

You must inject 2 pens to complete the entire 300 mg dose.
Parts of the Omvoh pen
Inject both pens in any order for a complete 300 mg dose.
The 200 mg pen is larger than the 100 mg pen.

Top Part

Blue injection button
Locking ring
Lock/unlock
symbols
Medicine
Needle
Transparent base
Grey base cap
Bottom Part
100 mg + 200 mg = 1 Complete Dose
IMPORTANT:

• 2 injections are required for a complete dose for the treatment of Crohn's disease: one 100 mg pen and one 200 mg pen
• Inject 1 pen immediately followed by the other pen.

Preparing the Omvoh injection
Take the pens out of the refrigeratorTake 2 pens out of the refrigerator.

Leave the grey base cap on until you are
ready to inject.
Leave the pens at room temperature for 45 minutes
before starting the injection.

Do notheat the pens in the microwave, run warm water over them, or leave them in direct sunlight.

Do notuse the pens if the medicine is frozen.

Do notshake the pens.

Prepare what you needYou will need:

• 2 alcohol swabs
• 2 cotton balls or gauze pads
• 1 sharps container (see "Disposing of Omvoh pens")

Inspect the pen and the medicineMake sure you have the correct medicine. The medicine
inside should be clear. It may be colorless to
light yellow.

Do notuse the pens and dispose of them as directed by
healthcare professionals if:

• it looks damaged
• the medicine is cloudy, discolored, or has particles
• the expiration date printed on the label has passed
• the medicine is frozen

Prepare for the injection
Expiration
date

Wash your hands with soap and water before injecting
Omvoh.

Choose the injection siteHealthcare professionals can help you choose the most
suitable injection site for you.

• You or another personcan inject the medicine into the area of the stomach (abdomen). Do notinject within 5 centimeters around the navel.
• You or another personcan inject the medicine into the front of the thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
• Another personcan give you the injection in the back of the arm.
• Do notinject in the same exact spot every time. For example, if the first injection was in the abdomen, the second injection, to deliver a complete dose, may be in another area of the abdomen.
• Do notinject in areas where the skin is sensitive, bruised, red, or hardened.

Clean the injection site with an alcohol swab.
Let the injection site dry before injecting the
medicine.
You or another person
can inject into these
areas.
In this area another
person must
inject.

Injecting Omvoh
1 Remove the cap from the pen

Make sure the pen islocked.
Leave the grey base cap on until
you are ready to inject.

• Unscrew the grey cap from the base and discard it in household waste.
• Do notput the grey cap back on the base
• this could damage the needle.
• Do nottouch the needle.

2 Position and unlock

• Position and hold the transparent base flat and firmly against the skin.

Hold the base against the skin and rotate
the locking ring to the

unlockposition.

3 Press and hold for a
maximum of 15 seconds

• Press and hold the blue injection button. You will feel a strong click (injection started).
• Continue to hold the transparent base firmly against the skin.You will feel a second strong click about 15 seconds after the first (injection completed).
• You will know the injection is complete when you see the grey plunger.
• Remove the pen from the skin.
• If there is bleeding at the injection site, press a cotton ball or gauze pad on the injection site.
• Do notrub the injection site.

15

2 injections are needed for a complete dose. Inject one pen immediately
followed by the other pen.
Disposing of Omvoh pens
Throw away used pens

• Place the used pen in a sharps container immediately after use. Do not throw the pen directly into household waste.
• If you do not have a sharps container, you can use a household container that:
• is made of durable plastic
• can be closed with a tight, puncture-resistant lid, without sharp objects protruding
• is upright and stable during use
• is leak-proof
• is properly labeled to warn of the presence of hazardous waste inside the container.
• When the sharps container is almost full, you will need to follow community guidelines for the proper way to dispose of the sharps container. There may be local laws about how to throw away needles and pens.
• Do not recycle the used sharps container.
• For more information on how to properly dispose of the container, ask your doctor about the options available in your area.

Frequently Asked Questions

• Q. What happens if I let my pen warm up for more than 30 minutes before injection?
• A.The pen can remain at room temperature up to 30°C for up to 2 weeks.
• Q. What happens if I see air bubbles in my pen?
• A.It is normal to have air bubbles in the pen. They are not dangerous or will affect the dose.
• Q. What happens if there is a drop of liquid on the tip of the needle when I remove the grey base cap?
• A.It is okay to see a drop of liquid on the tip of the needle. This will not harm or affect your dose.

• Q. What happens if I unlock the pen and press the blue injection button until the injection is
  complete?
• A.Do notremove the grey base cap. Do not use the pen. Talk to your doctor or pharmacist to get a new one.
• Q. Do I need to keep the blue injection button pressed until the injection is complete?
• A.You do not need to keep the blue injection button pressed, but it can help keep the pen stable and firm against the skin.
• Q. What happens if the needle does not retract after the injection?
• A.Do nottouch the needle or replace the grey base cap. Keep the pen in a safe place to avoid accidental punctures and contact your doctor, pharmacist, or nurse.
• Q. What happens if there is a drop of liquid or blood on the skin after the injection?
• A.This is normal. Press a cotton ball or gauze pad on the injection site. Do notrub the injection site.
• Q. What happens if I heard more than 2 clicks during the injection: 2 strong clicks and one weak click. Have
  I received the complete injection?
• A.Some patients may hear a slight click just before the second strong click. This is normal pen operation. Do notremove the pen from the skin until you hear the second strong click.
• Q. How can I know if my injection is complete?
• A.After pressing the blue injection button, you will hear 2 strong clicks. The second strong click indicates that the injection is complete. You will also see the grey plunger in the top part of the transparent base.

more information about this medicine.