OTULFI 45 mg Injectable Solution In Pre-Filled Syringe

Зміст інструкції

1. Otulfi 130 mg concentrate for solution for infusion
   1. What is Otulfi and what is it used for
   2. What you need to know before you use Otulfi
   3. How Otulfi will be used
   4. Possible side effects
   5. How to store Otulfi
   6. Package contents and other information
2. Otulfi 45 mg injectable solution in pre-filled syringe
   1. What is Otulfi and what is it used for
   2. What you need to know before using Otulfi
   3. How to use Otulfi
   4. Possible side effects
   5. How to store Otulfi
   6. OTHER INFORMATION
   7. Check the number of pre-filled syringes and prepare the materials
   8. Choose the injection site and prepare it
   9. Remove the protective cap from the needle (see Figure 3)
   10. Inject the dose
   11. After the injection
   12. Disposal
3. Otulfi 90 mg solution for injection in pre-filled syringe
   1. What is Otulfi and what is it used for
   2. What you need to know before using Otulfi
   3. How to use Otulfi
   4. Possible side effects
   5. How to store Otulfi
   6. Contents of the pack and other information
   7. Check the number of prefilled syringes and prepare the materials
   8. Choose the injection site and prepare it
   9. Remove the protective cap from the needle (see Figure 3)
   10. Inject the dose
   11. After the injection
   12. Disposal

Otulfi 130 mg concentrate for solution for infusion

ustekinumab

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.
This leaflet is written for people who are taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Otulfi and what is it used for

What is Otulfi
Otulfi contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific proteins
present in the body.
Otulfi belongs to a group of medicines called “immunosuppressants”. These medicines
reduce the activity of the immune system to some extent.

What is Otulfi used for
Otulfi is used to treat the following inflammatory disease:

• moderate to severe Crohn's disease in adults.

Crohn's Disease
Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will
first be treated with other medications. If you do not respond well enough or are intolerant to these
medicines, you may be given Otulfi to reduce the signs and symptoms of your disease.

2. What you need to know before you use Otulfi

Do not use Otulfi

• If you are allergic to ustekinumabor to any of the other ingredients of this medicine (listed in section 6)
• If you have an active infectionthat your doctor considers significant.

If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Otulfi.

Warnings and precautions
Talk to your doctor or pharmacist before using Otulfi. Your doctor will check your health status before treatment. Make sure to tell your doctor about any illnesses you have before starting treatment. Also, tell your doctor if you have recently been in contact with people who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before giving you Otulfi. If your doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

Pay attention to serious side effects
Otulfi can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Otulfi. See “Serious side effects” in section 4 for a complete list of these side effects.

Contact your doctor before using Otulfi

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are not sure.
• If you have ever had any type of cancer - this is because immunosuppressants likeOtulfi partially weaken the immune system.This can increase the risk ofcancer.
• If you have been treated for psoriasis with other biologic medicines (a medicinal productderived from a biological source and usually administered by injection)- the risk of cancer may be higher.
• If you have or have had a recent infection or if you have abnormal openings in your skin (fistulas).
• If you have ever had any new or changed skin lesionwithin the psoriasis area or on normal skin.
• If you are taking any other type of treatment for psoriasis and/or psoriatic arthritis- such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce the activity of the immune system. The simultaneous use of these therapies with Otulfi has not been studied. However, it is possible that it may increase the possibility of conditions related to a weakened immune system.
• If you are using or have ever used injections for the treatment of allergies- it is not known whether Otulfi may have an effect on them.
• If you are 65 years of age or older- you may have a greater chance of contracting infections.

If you are not sure if any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before undergoing treatment with Otulfi.
During treatment with ustekinumab, some patients have developed reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, and scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly check your risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of your body, facial drooping, or abnormalities in speech or vision.

Children and adolescents
Otulfi is not recommended for the treatment of children under 18 years of age with Crohn’s disease because it has not been studied in this age group.

Other medicines, vaccines and Otulfi
Tell your doctor or pharmacist:

• if you are taking, have recently taken or might take any other medicines
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Otulfi.
• if you received Otulfi during pregnancy, inform your child’s pediatrician about the treatment with Otulfi before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Otulfi during pregnancy, live vaccines are not recommended for your child in the first six months after birth, unless your child’s pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine.
• No increased risk of birth defects has been observed in newborns exposed to ustekinumab in the womb. However, there is limited experience with ustekinumab in pregnant women. Therefore, it is preferable to avoid the use of Otulfi during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during use of Otulfi and for at least 15 weeks after stopping treatment with Otulfi.
• Ustekinumab can reach the unborn child through the placenta. If you received Otulfi during pregnancy, your child may have an increased risk of infection.
• If you received Otulfi during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Otulfi during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first six months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab can be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Otulfi. You cannot do both.

Driving and using machines
Otulfi does not alter or negligibly alters the ability to drive vehicles and use machines.

Otulfi contains sodium
Otulfi contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
However, before Otulfi is administered, it is mixed with a solution containing sodium.
Talk to your doctor if you are following a low-salt diet.

3. How Otulfi will be used

Otulfi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and
treatment of Crohn's disease.
Otulfi 130 mg concentrate for solution for infusion will be administered to you by the physician, through
an intravenous drip in the arm vein (intravenous infusion) for at least one hour. Discuss with the physician
when you will need to undergo the injections and subsequent follow-up visits.

How much Otulfi is administered
The physician will decide how much Otulfi you need and for how long.

Adults starting from 18 years

• The physician will calculate the recommended intravenous infusion dose for you based on your weight

body weight.
Your body weight Dose
≤ 55 kg 260 mg
> 55 kg to ≤ 85 kg 390 mg
> 85 kg 520 mg

• After the initial intravenous dose, you will take the next dose of 90 mg Otulfi with an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks.

How Otulfi is administered
The first dose of Otulfi for the treatment of Crohn's disease is administered by the physician through
an intravenous drip in a vein in your arm (intravenous infusion).
Inform the physician if you have any questions about the use of Otulfi.

If you forget to use Otulfi
If you forget or miss the appointment for administering the dose, contact the physician to
schedule a new appointment.

If you stop using Otulfi
It is not dangerous to stop using Otulfi. However, if you stop treatment, the symptoms
may recur.
If you have further questions on the use of this medicine, ask your physician or
pharmacist.

4. Possible side effects

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

Serious side effects
Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek urgent medical attention if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or feeling lightheaded o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

Infusion-related reactions – If you are being treated for Crohn’s disease, the first dose of
Otulfi is given through an intravenous drip (intravenous infusion). Some patients have
experienced severe allergic reactions during the infusion of ustekinumab.
In rare cases, allergic lung reactions and lung inflammation have been reported in
patients receiving ustekinumab. Tell your doctor immediately if you develop symptoms such as
cough, shortness of breath, and fever.
If you have a severe allergic reaction, your doctor may decide that you should not use Otulfi
again.

Infections – these may require urgent treatment, so contact your doctor immediately
if you notice any of the following signs.

• Infections of the nose and throat and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (can affect up to 1 in 100 patients)
• Inflammation of the tissue under the skin (‘cellulitis’) is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful skin rash with blisters) is uncommon (affects up to 1 in 100 patients).

Otulfi may decrease your ability to fight infections. Some infections may become serious and
may include infections caused by viruses, fungi, bacteria (including tuberculosis) or
parasites, including infections that occur mainly in people with weakened immune systems
(opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in
patients treated with ustekinumab.
You should be attentive to signs of infection while you are using Otulfi. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warm, red and painful skin, or a painful rash with blisters
• burning when urinating
• diarrhea
• blurred vision or loss of vision
• headache, stiff neck, sensitivity to light, nausea or confusion

Tell your doctor immediately if you notice any of these signs of infection. These may
be signs of infection such as chest infections, skin infections, herpes zoster or opportunistic
infections that may have serious complications. See your doctor if you have any type of
infection that persists or keeps recurring. Your doctor may decide to stop Otulfi until
the infection resolves. Also tell your doctor if you have any cuts or open wounds that
may become infected.

Skin peeling – increased redness and peeling of the skin over a large
area of the body can be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which
are serious skin conditions. If you notice any of these signs you should tell
your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infection
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the place where the injection is given
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face (“facial paralysis” or “Bell’s palsy”), which is usually temporary
• A change in psoriasis with redness and new small, yellow or white bumps, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (shedding of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which can lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Blistering skin formation with possible redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised and scaly rash on areas of skin exposed to the sun, sometimes with joint pain).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 Otulfi

• Otulfi 130 mg concentrate for infusion solution is administered in hospital or clinic and patients do not need to handle or store it.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C-8 °C). Do not freeze.
• Keep the vial in the outer packaging to protect the medicine from light.
• Do not shake the vials of Otulfi. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date that is stated on the label and the outer packaging after “Exp.”. The expiry date refers to the last day of the month.
• If the liquid has a changed colour, is cloudy or if you see foreign particles floating (see section 6 “Description of Otulfi and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously.
• If the seal is broken.

Otulfi is for single use. The unused diluted solution for infusion remaining in the vial and in the syringe
must be disposed of in accordance with local regulations.

6. Package contents and other information

What Otulfi contains

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 mL.
• The excipients are: disodium edetate dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Otulfi and package contents
Otulfi is a clear concentrate for infusion solution, from colorless to slightly brown-yellow.
It is supplied in a cardboard package containing 1 single dose, in a 30 mL glass vial. Each
vial contains 130 mg of ustekinumab in 26 mL of concentrate for infusion solution.

Marketing authorisation holder
Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz Austria
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu/
The following information is intended exclusively for healthcare professionals.
Traceability
In order to improve the traceability of biological medicines, the trade name and batch number
of the administered product must be clearly recorded.
Instructions for dilution.
Otulfi concentrate for infusion solution must be diluted, prepared and infused by a healthcare
professional using aseptic technique.

• 1. Calculate the dose and the number of vials of Otulfi needed based on the patient's weight (see section 3, Table 1). Each 26 mL vial of Otulfi contains 130 mg of ustekinumab.
• 2. Remove and discard a volume of sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of Otulfi to be added (discard 26 mL of sodium chloride for each vial of Otulfi needed, for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
• 3. Withdraw 26 mL of Otulfi from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Mix gently.
• 4. Visually inspect the diluted solution before infusion. Do not use if visible opaque particles, discoloration or foreign particles are observed.
• 5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion must be completed within 24 hours of dilution in the infusion bag.
• 6. Use only one sterile, non-pyrogenic, low protein-binding infusion set with an in-line filter (pore size 0.2 micrometers).
• 7. Each vial is for single use and unused medicine must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution must be stored at room temperature.
The infusion must be completed within 24 hours of dilution in the infusion bag. Do not
freeze.

Otulfi 45 mg injectable solution in pre-filled syringe

ustekinumab

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.
This leaflet is written for people taking this medicine. If you are the parent or
carer of a child to whom Otulfi needs to be administered, read
these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Otulfi and what is it used for

What is Otulfi
Otulfi contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific proteins
present in the body.
Otulfi belongs to a group of medicines called “immunosuppressants”. These medicines
reduce the activity of the immune system to some extent.

What is Otulfi used for
Otulfi is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children starting from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
Otulfi will reduce the inflammation and other signs of the disease.
Otulfi is used in adults with moderate to severe plaque psoriasis, who cannot use
cyclosporine, methotrexate or phototherapy, or in whom these treatments do not work.
Otulfi is used in children and adolescents starting from 6 years of age with moderate to severe plaque psoriasis, who cannot tolerate phototherapy or other systemic therapies or when these treatments
have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis. If you have active psoriatic arthritis you will first be treated with other medicines. If you should
not respond adequately to these medicines, you may take Otulfi to:

• reduce the signs and symptoms of the disease.
• improve physical function.
• slow down joint damage.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the intestine. If you have Crohn’s disease you will
be treated first with other medicines. If you do not respond sufficiently well or are intolerant to these
medicines, you may be given Otulfi to reduce the signs and symptoms of your disease.

2. What you need to know before using Otulfi

Do not use Otulfi

• If you are allergic to ustekinumabor to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infectionthat your doctor considers significant.

If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using Otulfi.

Warnings and precautions
Talk to your doctor or pharmacist before using Otulfi. Your doctor will check your health status before each treatment. Make sure to tell your doctor about any illnesses you have before each treatment. Also, tell your doctor if you have recently been in contact with people who may have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before giving you Otulfi. If your doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

Pay attention to serious side effects
Otulfi can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Otulfi. See “Serious side effects” in section 4 for a complete list of these side effects.

Contact your doctor before using Otulfi

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are not sure.
• If you have ever had any type of cancer- this is because immunosuppressants like Otulfi partially weaken the immune system. This can increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicinal product derived from a biological source and usually administered by injection)- the risk of cancer may be higher.
• If you have or have had a recent infection.
• If you have ever had any new or changed lesionwithin the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to the injection of Otulfi- See “Pay attention to serious side effects” in section 4 for the signs of an allergic reaction.
• If you are taking any other type of treatment for psoriasis and/or psoriatic arthritis- such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce the activity of the immune system. The concurrent use of these therapies with Otulfi has not been studied.

However, it is possible that this may increase the possibility of conditions related to a weakened immune system.

• If you are using or have ever used injections for the treatment of allergies- it is not known whether Otulfi can have an effect on them.
• If you are 65 years of age or older- you may be more likely to get infections.

If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before undergoing treatment with Otulfi.
During treatment with ustekinumab, some patients have developed reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly check risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision abnormalities.

Children and adolescents
Otulfi is not recommended for the treatment of children with psoriasis under the age of 6, or for the treatment of children under the age of 18 with psoriatic arthritis and Crohn's disease because it has not been studied in this age group.

Other medicines, vaccines and Otulfi
Tell your doctor or pharmacist:

• if you are taking, have recently taken or may take any other medicines
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be given while you are using Otulfi.
• if you received Otulfi during pregnancy, inform your child’s pediatrician about the Otulfi treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Otulfi during pregnancy, live vaccines are not recommended for your child in the first six months after birth, unless your child’s pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• No increased risk of birth defects has been observed in newborns exposed to ustekinumab in utero. However, there is limited experience with ustekinumab in pregnant women. Therefore, it is preferable to avoid the use of Otulfi during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during the use of Otulfi and for at least 15 weeks after stopping treatment with Otulfi.
• Ustekinumab can reach the newborn through the placenta. If you received Otulfi during pregnancy, your child may be at increased risk of infection.
• If you received Otulfi during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Otulfi during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first six months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab can be excreted in breast milk in very small amounts. If you are breastfeeding or

breastfeeding, ask your doctor for advice. You and your doctor will decide whether you should breastfeed or use Otulfi. You cannot do both.

Driving and using machines
Otulfi does not alter or negligibly alters the ability to drive vehicles and use machines.

3. How to use Otulfi

Otulfi is intended for use under the guidance and supervision of a physician experienced in the treatment
of the conditions for which Otulfi is indicated.
Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor. Discuss with your doctor when you will need to receive the injections and subsequent check-up visits.

How much Otulfi is administered
The doctor will decide how much Otulfi you need and for how long.

Adults starting from 18 years
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Otulfi. Patients with a weight greater than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, you will receive the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn's Disease

• During treatment, the first dose of approximately 6 mg/kg of Otulfi will be administered to you by the doctor via an intravenous infusion into a vein in your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of Otulfi after 8 weeks, then every 12 weeks with an injection under the skin (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Otulfi may be administered every 8 weeks. The doctor will decide when you should receive the next dose.

Children and adolescents starting from 6 years
Psoriasis

• The doctor will calculate the correct dose, including the amount (volume) of Otulfi that must be injected to ensure the administration of the correct dose. The correct dose will depend on the child's body weight at the time of administration of each dose.
• If the body weight is less than 60 kg, there is no formulation of Otulfi for children with a body weight of less than 60 kg, therefore other medicines based on ustekinumab must be used.
• If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Otulfi.
• If the weight exceeds 100 kg, the recommended dose is 90 mg of Otulfi.
• After the initial dose, you will receive the next dose after 4 weeks, and subsequently every 12 weeks.

How is Otulfi administered
Otulfi is administered by a subcutaneous injection (“by the subcutaneous route”). At the beginning of
treatment, medical or nursing staff may inject Otulfi for you.

• However, you and your doctor can decide whether you can inject Otulfi yourself. In this case, you will be taught how to inject Otulfi yourself. In children starting from 6 years, it is recommended that Otulfi be administered by a healthcare professional or the person caring for the child, after adequate training.
• For instructions on how to inject Otulfi, see “Instructions for Administration” at the end of

Inform your doctor if you have any questions about the injection to be performed yourself.

If you use more Otulfi than you should
If you have used or received too much Otulfi, inform your doctor or pharmacist immediately. Always bring
the outer packaging of the medicine with you, even if it is empty.

If you forget to use Otulfi
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for
the missed dose.

If you stop using Otulfi
It is not dangerous to stop using Otulfi. However, if you stop treatment, the symptoms
may reappear. If you have further questions about the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek urgent medical attention if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or lightheadedness o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and pulmonary inflammation have been reported in patients receiving ustekinumab. Tell your doctor immediately if you develop symptoms such as cough, shortness of breath, and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Otulfi again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Infections of the nose and throat and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients)
• Inflammation of the subcutaneous tissue (‘cellulitis’) is uncommon (affects up to 1 in 100 patients).
• Herpes zoster (a type of painful skin rash with blisters) is uncommon (affects up to 1 in 100 patients).

Otulfi may decrease your ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur primarily in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients treated with ustekinumab.
You should be attentive to signs of infection while using Otulfi. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin, or a painful, blistering rash
• burning when urinating
• diarrhea
• vision disturbance or loss of vision
• headache, stiff neck, sensitivity to light, nausea or confusion

Tell your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster, or opportunistic infections that may have serious complications. See your doctor if you have any type of infection that persists or continues to recur. Your doctor may decide to stop Otulfi until the infection resolves. Also, tell your doctor if you have any cuts or open wounds that may become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, you should tell your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infection
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle relaxation on one side of the face (“facial paralysis” or “Bell’s palsy”), which is usually temporary
• A change in psoriasis with redness and new small, yellow or white pustules, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural evolution in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which can lead to a rash with small

red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters with possible redness, itching, and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised, and scaly rash on areas of skin exposed to the sun, sometimes with joint pain).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 Otulfi

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C-8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Otulfi can also be stored at room temperature up to 30 °C, for a single period of a maximum of 30 days, in the outer packaging in order to protect them from light. Record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date on which it should be discarded in the spaces provided on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever is earlier.
• Do not shake the pre-filled syringes of Otulfi. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date that is stated on the label and the carton after EXP or Scad. The expiry date refers to the last day of the month.
• If the liquid has a discoloured appearance, is cloudy or if you see foreign particles floating (see section 6 “Description of Otulfi and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously. Otulfi is for single use. Any unused product remaining in the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Otulfi contains

• The active ingredient is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The excipients are: L-histidine, polysorbate 80 (E433), sucrose, water for injections and hydrochloric acid (for pH adjustment).

Description of the appearance of Otulfi and contents of the pack
Otulfi is a clear injection solution, from colourless to slightly brown-yellow. It is supplied in
a carton containing 1 single dose, in a 1 mL glass pre-filled syringe. Each
pre-filled syringe contains a dose of 45 mg ustekinumab in 0.5 mL of injection solution.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz Austria
More detailed information on this medicine is available on the website of the European
Medicines Agency: https://www.ema.europa.eu/ .

Instructions for administration
At the beginning of treatment, the doctor will assist you during the first injection. However, you and the doctor
may decide whether you can inject Otulfi yourself. In this case, you will be taught how to inject Otulfi by
yourself. Inform the doctor if you have any questions about the injection to be performed by
yourself. In children from 6 years of age, it is recommended that Otulfi is administered by a healthcare
professional or by the person caring for the child, after adequate training.

• Do not mix Otulfi with other injection liquids.
• Do not shake the pre-filled syringes of Otulfi, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows the appearance of the pre-filled syringe.

Figure 1

1. Check the number of pre-filled syringes and prepare the materials

Prepare for the use of the pre-filled syringes.

• Remove the pre-filled syringe or pre-filled syringes from the refrigerator. Leave the pre-filled syringe out of its packaging for about half an hour. This will allow the liquid to reach a comfortable temperature for injection (room temperature). Do not remove the needle protective cap while waiting to reach room temperature.
• Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upwards.
• Do not hold by the plunger head, the plunger, the needle shield, or the needle protective cap.
• Do not pull back the plunger under any circumstances.
• Do not remove the needle cap from the pre-filled syringe until it is necessary.
• Do not touch the activation clip of the protection (as indicated by the asterisk * in Figure 1) to prevent premature covering of the needle with the needle shield.
• Do not use the pre-filled syringe if it has fallen onto a hard surface.

Check the pre-filled syringe to ensure that:

• the number of pre-filled syringes and the dose are correct or if your dose is 45 mg, you will take one 45 mg pre-filled syringe of Otulfi or if your dose is 90 mg, you will take two 45 mg pre-filled syringes of Otulfi and you will need to perform two injections. Choose two different body sites for these injections (for example, one injection on the right thigh and the other injection on the left thigh), and proceed with the injections one after the other
• the medicine is the correct one
• the medicine has not expired
• the pre-filled syringe is not damaged
• the solution in the pre-filled syringe is clear, from colorless to slightly brown-yellow
• the liquid in the pre-filled syringe does not have an altered or cloudy color and does not contain foreign particles
• the solution in the pre-filled syringe is not frozen

Take everything you need and place it on a clean surface. There should be antiseptic wipes, a
cotton ball or gauze and a sharps container.

2. Choose the injection site and prepare it

Choose a site for the injection (see Figure 2).

• Otulfi is administered by injection under the skin (subcutaneously).
• A good place for the injection is the upper thigh or around the abdomen (belly) at least 5 cm away from the navel.
• If possible, do not choose areas of skin with signs of psoriasis.
• If someone is assisting you during the injection, they can also choose the upper arms as an injection site.

Figure 2: The gray areas are the recommended sites for the injection
Prepare the injection site

• Wash your hands very well with soap and warm water.
• Rub the injection site on the skin with an antiseptic wipe.
• Do nottouch this area again before performing the injection.

3. Remove the protective cap from the needle (see Figure 3)

• The protective cap of the needle must notbe removed until you are ready to inject the dose.
• Take the pre-filled syringe, hold the syringe by its body with one hand.
• Remove the protective cap from the needle and discard it. Do not touch the plunger while performing this operation.

Figure 3

• If you should notice an air bubble in the pre-filled syringe or a drop of liquid on the tip of the needle, this is normal. They should not be removed.
• Do not touch the needle and avoid letting the needle touch any surface
• Do not use the pre-filled syringe if it is pulled out without the protective cap of the needle in place. If this happens, contact your doctor or pharmacist.
• Inject the contents immediately after removing the protective cap from the needle.

4. Inject the dose

• Hold the pre-filled syringe in one hand between your middle and index fingers and place your thumb on top of the plunger head, using the other hand to gently pinch the cleaned skin area between your thumb and index finger. Do not pinch too tightly.
• Do not pull back on the plunger in any way.
• With one quick motion, insert the needle into the skin until it is as far as it will go (see Figure 4).

Figure 4

• Inject all of the liquid by pushing the plunger in until the plunger head is completely between the needle shield wings (see Figure 5).

Figure 5

• Push the plunger in until it reaches the end of its travel and continue to hold the plunger head down while you withdraw the needle and gently release the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty syringe to rise upwards and the needle to be completely covered by the shield wings, as shown in Figure 7.

Figure 7

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You can press a cotton ball or gauze on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you can cover the injection site with a small bandage, if necessary.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see figure 8). For your health and safety and for the safety of others, never reuse the syringe. Dispose of the sharps container in accordance with local regulations.
• Antiseptic swabs and other devices can be disposed of in the waste.

Figure 8

Otulfi 90 mg solution for injection in pre-filled syringe

ustekinumab

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.
This leaflet is written for people who are taking this medicine. If you are the parent or
carer of a child to whom Otulfi needs to be administered, read
this information carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Otulfi and what is it used for

What is Otulfi
Otulfi contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to specific proteins
present in the body.
Otulfi belongs to a group of medicines called “immunosuppressants”. These medicines
reduce the activity of the immune system to some extent.

What is Otulfi used for
Otulfi is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children starting from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults

Plaque psoriasis
Plaque psoriasis is a skin condition that causes inflammation of the skin and nails.
Otulfi will reduce inflammation and other signs of the disease.
Otulfi is used in adults with moderate to severe plaque psoriasis, who cannot use
cyclosporine, methotrexate or phototherapy, or in whom these treatments do not work.
Otulfi is used in children and adolescents starting from 6 years of age with moderate to
severe plaque psoriasis, who cannot tolerate phototherapy or other systemic therapies or when these treatments
have not worked.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis. If you have active psoriatic arthritis you will first be treated with other medicines. If you should
not respond adequately to these medicines, you may take Otulfi to:

• reduce the signs and symptoms of the disease
• improve physical function
• slow down joint damage

Crohn’s disease
Crohn’s disease is an inflammatory disease of the intestine. If you have Crohn’s disease you will
be treated first with other drugs. If you do not respond well enough or are intolerant to these
medicines, you may be given Otulfi to reduce the signs and symptoms of your disease.

2. What you need to know before using Otulfi

Do not use Otulfi

• If you are allergic to ustekinumabor to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infectionthat your doctor considers significant.

If you are not sure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using Otulfi.

Warnings and precautions
Talk to your doctor or pharmacist before using Otulfi. The doctor will check your health status before each treatment. Make sure to inform the doctor about any illnesses you have before each treatment. Also, tell your doctor if you have recently been in contact with people who may have had tuberculosis. The doctor will examine you and perform tests for tuberculosis before administering Otulfi. If your doctor believes you are at risk of tuberculosis, they may give you medicines to treat tuberculosis.

Pay attention to serious side effects
Otulfi can cause serious side effects, including allergic reactions and infections. You should pay attention to certain signs of illness while taking Otulfi. See “Serious side effects” in section 4 for a complete list of these side effects.

Contact your doctor before using Otulfi

• If you have ever had an allergic reaction to ustekinumab. Ask your doctor if you are not sure.
• If you have ever had any type of cancer- this is because immunosuppressants like Otulfi partially weaken the immune system. This can increase the risk of cancer.
• If you have been treated for psoriasis with other biologic medicines (a medicinal product derived from a biological source and usually administered by injection)- the risk of cancer may be higher.
• If you have or have had a recent infection.
• If you have ever had any new or changed lesionwithin the area of psoriasis or on normal skin.
• If you have ever had an allergic reaction to the injection of Otulfi- See “Pay attention to serious side effects” in section 4 for the signs of an allergic reaction.
• If you are taking any other type of treatment for psoriasis and/or psoriatic arthritis- such as another immunosuppressant or phototherapy (when the body is treated with a type of ultraviolet (UV) light). These treatments can also partially reduce the activity

of the immune system. The simultaneous use of these therapies with Otulfi has not been studied.
However, it is possible that it may increase the possibility of conditions related to a
weakened immune system.

• If you are using or have ever used injections for the treatment of allergies- it is not known whether Otulfi can have an effect on them.
• If you are 65 years of age or older- you may have a greater chance of contracting infections.

If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before undergoing treatment with Otulfi.
During treatment with ustekinumab, some patients have experienced reactions similar to lupus, including cutaneous lupus or lupus-like syndrome. Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker edge, in areas of skin exposed to the sun or with joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attack and stroke were observed. The doctor will regularly check risk factors for heart disease and stroke to ensure they are treated appropriately. Contact a doctor immediately if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision abnormalities.

Children and adolescents
Otulfi is not recommended for the treatment of children with psoriasis under the age of 6, or for the treatment of children under the age of 18 with psoriatic arthritis or Crohn's disease because it has not been studied in this age group.

Other medicines, vaccines and Otulfi
Tell your doctor or pharmacist:

• if you are taking, have recently taken or may take any other medicines
• if you have recently been vaccinated or are about to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Otulfi.
• if you received Otulfi during pregnancy, inform your child's pediatrician about the treatment with Otulfi before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Otulfi during pregnancy, live vaccines are not recommended for your child in the first six months after birth, unless your child's pediatrician recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• No increased risk of birth defects has been observed in newborns exposed to ustekinumab in utero. However, there is limited experience with ustekinumab in pregnant women. Therefore, it is preferable to avoid the use of Otulfi during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during use of Otulfi and for at least 15 weeks after stopping treatment with Otulfi.
• Ustekinumab can reach the newborn through the placenta. If you received Otulfi during pregnancy, your baby may have an increased risk of contracting an infection.
• If you received Otulfi during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Otulfi during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first six months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab can be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Otulfi. You cannot do both.

Driving and using machines
Otulfi does not alter or negligibly alters the ability to drive vehicles and use machines.

3. How to use Otulfi

Otulfi is intended for use under the guidance and supervision of a physician experienced in the treatment
of the conditions for which Otulfi is indicated.
Use this medicine always exactly as your doctor has instructed. If you have any doubts, ask your
doctor. Discuss with your doctor when you should have the injections and subsequent check-up visits.

How much Otulfi is administered
Your doctor will decide how much Otulfi you need and for how long.

Adults starting from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Otulfi. Patients with a weight greater than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• After the initial dose, you will take the next dose 4 weeks later, and then every 12 weeks. Subsequent doses are usually the same as the initial dose.

Crohn’s Disease

• During treatment, the first dose of approximately 6 mg/kg of Otulfi will be administered to you by your doctor via an intravenous infusion into a vein in your arm. After the initial dose, you will receive the next dose of 90 mg of Otulfi after 8 weeks, then every 12 weeks with an injection under the skin (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Otulfi may be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents starting from 6 years of age
Psoriasis

• The doctor will calculate the correct dose, including the amount (volume) of Otulfi that must be injected to ensure the administration of the correct dose. The correct dose will depend on the child's body weight at the time of administration of each dose.
• If the body weight is less than 60 kg, there is no formulation of Otulfi for children with a body weight less than 60 kg, therefore other medicines based on ustekinumab must be used.
• If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Otulfi.
• If the weight exceeds 100 kg, the recommended dose is 90 mg of Otulfi.
• After the initial dose, you will receive the next dose after 4 weeks, and subsequently every 12 weeks.

How Otulfi is administered
Otulfi is administered by a subcutaneous injection (“by the subcutaneous route”). At the beginning of
treatment, medical or nursing staff may inject Otulfi for you.

• However, you and your doctor can decide whether you can inject Otulfi yourself. In this case, you will be taught how to inject Otulfi yourself. In children starting from 6 years of age, it is recommended that Otulfi be administered by a healthcare professional or the person caring for the child, after adequate training.
• For instructions on how to inject Otulfi, see “Instructions for administration” at the end of

Inform your doctor if you have any questions about the injection to perform yourself.

If you use more Otulfi than you should
If you have used or received too much Otulfi, inform your doctor or pharmacist immediately. Always
carry the outer packaging of the medicine with you, even if it is empty.

If you forget to use Otulfi
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for
the missed dose.

If you stop using Otulfi
It is not dangerous to stop using Otulfi. However, if you stop treatment, the symptoms
may recur. If you have further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Some patients may experience serious side effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment, so contact your doctor or seek urgent medical attention if you notice any of the following signs.

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ustekinumab (affecting up to 1 in 1,000 patients). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or lightheadedness o swelling of the face, lips, mouth or throat.
• Common signs of an allergic reaction include skin rash and hives (affecting up to 1 in 100 patients).

In rare cases, allergic lung reactions and pulmonary inflammation have been reported in patients receiving ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath and fever.
If you experience a severe allergic reaction, your doctor may decide that you should not use Otulfi again.

Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal and throat infections and the common cold are common (affecting up to 1 in 10 patients).
• Chest infections are uncommon (may affect up to 1 in 100 patients)
• Inflammation of the subcutaneous tissue (‘cellulitis’) is uncommon (affecting up to 1 in 100 patients).
• Herpes zoster (a type of painful blistering rash) is uncommon (affecting up to 1 in 100 patients).

Otulfi may decrease your ability to fight infections. Some infections may become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis) or parasites, including infections that occur primarily in people with weakened immune systems (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs and eyes have been reported in patients treated with ustekinumab.
You should be attentive to signs of infection while using Otulfi. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warm, red and painful skin, or a painful blistering rash
• burning when urinating
• diarrhea
• visual disturbance or loss of vision
• headache, stiff neck, sensitivity to light, nausea or confusion

Inform your doctor immediately if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, herpes zoster or opportunistic infections that may have serious complications. See your doctor if you have any type of infection that persists or continues to recur. Your doctor may decide to stop Otulfi until the infection resolves. Also, inform your doctor if you have any cuts or open wounds that may become infected.

Skin peeling – increased redness and peeling of the skin over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. If you notice any of these signs, you should inform your doctor immediately.
Other side effects
Common side effects (affect up to 1 in 10 patients)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• Headache
• Itching
• Back, muscle or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon side effects (affect up to 1 in 100 patients)

• Dental infection
• Vaginal fungal infection
• Depression
• Stuffy or runny nose
• Bleeding, bruising, stiffness, swelling and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness on one side of the face (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small, yellow or white pustules, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects (affect up to 1 in 1,000 patients)

• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural progression in the type of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which can lead to a rash with small red or purple bumps, fever or joint pain (vasculitis)

Very rare side effects (affect up to 1 in 10,000 patients)

• Formation of skin blisters with possible redness, itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (red, raised and scaly rash on areas of skin exposed to the sun, sometimes with joint pain).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 Otulfi

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C-8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
• If necessary, individual pre-filled syringes of Otulfi can also be stored at room temperature up to 30 °C, for a single period of a maximum of 30 days, in the outer packaging in order to protect them from light. Record the date on which the pre-filled syringe is removed from the refrigerator for the first time and the date it should be discarded in the spaces provided on the outer packaging. The discard date must not exceed the original expiry date printed on the packaging. Once a syringe has been stored at room temperature (up to 30 °C), it must not be returned to the refrigerator. Discard the syringe if not used within 30 days at room temperature or by the original expiry date, whichever is earlier.
• Do not shake the pre-filled syringes of Otulfi. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date that is stated on the label and the outer packaging after EXP or Scad. The expiry date refers to the last day of the month.
• If the liquid has a discoloured appearance, is cloudy or if you see foreign particles floating (see section 6 “Description of Otulfi and contents of the pack”).
• If you know or suspect that the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been shaken vigorously. Otulfi is for single use. Any unused product remaining in the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your 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 Otulfi contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The excipients are: L-histidine, polysorbate 80 (E433), sucrose, water for injections and hydrochloric acid (for pH adjustment).

Description of the appearance of Otulfi and contents of the pack
Otulfi is a clear injection solution, from colourless to slightly brown-yellow. It is supplied in
a cardboard pack containing 1 single dose, in a 1 mL glass pre-filled syringe. Each
pre-filled syringe contains a dose of 90 mg ustekinumab in 1 mL of solution for injection.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
8055 Graz Austria
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu/ .

Instructions for administration
At the beginning of treatment, your doctor will assist you during the first injection. However, you and your doctor
may decide if you can inject Otulfi yourself. In this case, you will be taught how to inject Otulfi by
yourself. Inform your doctor if you have any questions about the injection to be performed by
yourself. In children from 6 years of age, it is recommended that Otulfi is administered by a healthcare
professional or by the person caring for the child, after adequate training.

• Do not mix Otulfi with other injection liquids.
• Do not shake the pre-filled syringes of Otulfi, as vigorous shaking can damage the medicinal product. Do not use the medicinal product if it has been vigorously shaken.

Figure 1 shows the appearance of the pre-filled syringe.

Figure 1

1. Check the number of prefilled syringes and prepare the materials

Prepare for the use of the prefilled syringes.

• Remove the prefilled syringe or prefilled syringes from the refrigerator. Leave the prefilled syringe out of its packaging for about half an hour. This will allow the liquid to reach a comfortable temperature for injection (room temperature). Do not remove the needle protective cap while waiting to reach room temperature.
• Hold the prefilled syringe by its body with the covered needle pointing upwards.
• Do not hold by the plunger head, the plunger, the needle shield or the needle protective cap.
• Do not pull back the plunger under any circumstances.
• Do not remove the needle cap from the prefilled syringe until necessary.
• Do not touch the activation clip of the protection (as indicated by the asterisk * in Figure 1) to prevent premature covering of the needle with the needle shield.
• Do not use the prefilled syringe if it has fallen onto a hard surface.

Check the prefilled syringe to ensure that:

• the number of prefilled syringes and the dose are correct or if its dose is 90 mg, take a 90 mg prefilled syringe of Otulfi
• the medicine is the correct one
• the medicine has not expired
• the prefilled syringe is not damaged
• the solution in the prefilled syringe is clear, from colorless to slightly brown-yellow
• the liquid in the prefilled syringe does not have a changed or cloudy color and does not contain foreign particles
• the solution in the prefilled syringe is not frozen.

Take everything you need and place it on a clean surface. There should be antiseptic wipes, a
cotton ball or gauze and a sharps container.

2. Choose the injection site and prepare it

Choose a site for the injection (see Figure 2).

• Otulfi is administered by injection under the skin (subcutaneously).
• A good place for the injection is the upper thigh or around the abdomen (belly) at least 5 cm away from the navel.
• If possible, do not choose areas of skin with signs of psoriasis.
• If someone assists you during the injection, they can also choose the upper arms as an injection site.

Figure 2: The grey areas are the recommended sites for the injection
Prepare the injection site.

• Wash your hands very well with soap and warm water.
• Rub the injection site on the skin with an antiseptic wipe.
• Do nottouch this area again before performing the injection.

3. Remove the protective cap from the needle (see Figure 3)

• The protective cap of the needle must notbe removed until you are ready to inject the dose.
• Take the pre-filled syringe, hold the syringe by its body with one hand.
• Remove the protective cap from the needle and discard it. Do not touch the plunger while performing this operation.

Figure 3

• If you should notice an air bubble in the pre-filled syringe or a drop of liquid on the tip of the needle, this is normal. They should not be removed.
• Do not touch the needle and avoid letting the needle touch any surface.
• Do not use the pre-filled syringe if it is pulled out without the protective cap of the needle in place. If this happens, contact your doctor or pharmacist.
• Inject the contents immediately after removing the protective cap from the needle.

4. Inject the dose

• Hold the pre-filled syringe in one hand between your middle and index fingers and place your thumb on top of the plunger head, and use the other hand to gently pinch the cleaned skin area holding it between your thumb and index finger. Do not pinch too tightly.
• Do not pull back the plunger in any way.
• With one quick motion, insert the needle into the skin until it is as far as it will go (see Figure 4).

Figure 4

• Inject all of the liquid by pushing the plunger in until the plunger head is completely between the needle guard wings (see Figure 5).

Figure 5

• Push the plunger in until it has reached the end of its travel and continue to hold the plunger head pressed down while you withdraw the needle and gently release the skin (see Figure 6).

Figure 6

• Slowly remove your thumb from the plunger head to allow the empty syringe to rise up and the needle to be completely covered by the guard wings, as shown in Figure 7.

Figure 7

5. After the injection

• Press an antiseptic swab on the injection site for a few seconds after the injection.
• There may be a small amount of blood or fluid at the injection site. This is normal.
• You can press a cotton ball or gauze on the injection site and hold it for 10 seconds.
• Do not rub the skin at the injection site: you can cover the injection site with a small bandage if necessary.

6. Disposal

• Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your health and safety and the safety of others, never reuse the syringe. Dispose of the sharps container in accordance with local regulations.
• Antiseptic swabs and other devices can be disposed of in the waste.

Figure 8