UZPRUVO 45 mg Injectable Solution In Pre-Filled Syringe

Зміст інструкції

1. Uzpruvo 130 mg concentrate for solution for infusion
   1. What is Uzpruvo and what is it used for
   2. What you need to know before you use Uzpruvo
   3. How to use Uzpruvo
   4. Possible side effects
   5. How to store Uzpruvo
   6. Package Contents and Other Information
2. Uzpruvo 45 mg injectable solution in pre-filled syringe
   1. What is Uzpruvo and what is it used for
   2. What you need to know before using Uzpruvo
   3. How to use Uzpruvo
   4. Possible side effects
   5. How to store Uzpruvo
   6. Package Contents and Other Information
   7. Prepare the materials
   8. Choose the injection site and prepare it
   9. Remove the needle cap (see Figure 4):
   10. Inject the dose
   11. After the injection
3. Uzpruvo 90 mg solution for injection in pre-filled syringe
   1. What is Uzpruvo and what is it used for
   2. What you need to know before using Uzpruvo
   3. How to use Uzpruvo
   4. Possible side effects
   5. How to store Uzpruvo
   6. Package Contents and Other Information
   7. Prepare the materials
   8. Choose the injection site and prepare it
   9. Remove the needle cap (see Figure 4):
   10. Inject the dose
   11. After the injection

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

1. What is Uzpruvo and what is it used for

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

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

• moderate to severe Crohn’s disease in adults.

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

2. What you need to know before you use Uzpruvo

Do not use Uzpruvo

• 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 Uzpruvo.

Warnings and precautions
Talk to your doctor or pharmacist before using Uzpruvo. Your doctor will check your health before starting treatment. Make sure to tell your doctor about any medical conditions 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 Uzpruvo. If your doctor thinks you are at risk of tuberculosis, they may give you medicines to treat it.

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

Contact your doctor before using Uzpruvo

• If you have ever had an allergic reaction to Uzpruvo. Ask your doctor if you are not sure.
• If you have ever had any type of cancer- this is because immunosuppressants like Uzpruvo 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 productderived from a biological source and usually given by injection)- the risk of cancer may be higher.
• If you have or have had a recent infectionor if you have abnormal openings in the skin (fistulas).
• If you have ever had any new or changed skin lesionwithin the area of psoriasis 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 Uzpruvo 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 Uzpruvo 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 may apply to you, talk to your doctor or pharmacist before undergoing treatment with Uzpruvo.
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 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 the body, facial drooping, or speech or vision abnormalities.

Children and adolescents
Uzpruvo 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 Uzpruvo
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 Uzpruvo.
• If you received Uzpruvo during pregnancy, tell your child’s pediatrician about the Uzpruvo treatment before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Uzpruvo during pregnancy, live vaccines are not recommended for your child in the first twelve 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 the womb. However, there is limited experience with ustekinumab in pregnant women. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant and to use appropriate contraception during use of Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo.
• Ustekinumab can reach the newborn through the placenta. If you received Uzpruvo during pregnancy, your child may have an increased risk of infection.
• If you received Uzpruvo during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Uzpruvo during pregnancy, live vaccines such as the BCG vaccine (used for the prevention of tuberculosis) are not recommended for your child in the first twelve months after birth, unless your pediatrician recommends otherwise.
• Ustekinumab can be excreted in small amounts in breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Uzpruvo. You cannot do both.

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

Uzpruvo contains sodium and polysorbate 80
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially ‘sodium-free’. However, before Uzpruvo is given, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low-salt diet.
This medicine contains 0.4 mg of polysorbate 80 per ml. Polysorbates can cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use Uzpruvo

Uzpruvo is intended for use under the guidance and supervision of a physician experienced in the diagnosis
and treatment of Crohn's disease.
Uzpruvo 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 your physician
when you will need to undergo the injections and subsequent follow-up visits.

How much Uzpruvo is administered
The physician will decide how much Uzpruvo 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 body weight.

Your body weightDose
≤ 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 of Uzpruvo with an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks.

How Uzpruvo is administered

• The first dose of Uzpruvo 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 your physician if you have any questions about the use of Uzpruvo.

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

If you stop taking Uzpruvo
It is not dangerous to stop using Uzpruvo. However, if you stop treatment, the symptoms
may reappear.
If you have any doubts about the use of this medicine, consult your physician 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 medical treatment.

Allergic reactions - these may require urgent medical 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 (may affect up to 1 in 1,000 people). 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 (may affect up to 1 in 100 people).

Infusion-related reactions - If you are being treated for Crohn's disease, the first dose of
Uzpruvo is administered through an intravenous drip (intravenous infusion). Some patients
have experienced severe allergic reactions during the infusion.
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 experience a severe allergic reaction, your doctor may decide that you should not use Uzpruvo
again.

Infections - these may require urgent medical 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 (may affect up to 1 in 10 people).
• Chest infections are uncommon (may affect up to 1 in 100 people)
• Inflammation of the subcutaneous tissue (‘cellulitis’) is uncommon (may affect up to 1 in 100 people).
• Herpes zoster (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

Uzpruvo 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 careful to watch for signs of infection while using Uzpruvo. 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
• 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 Uzpruvo until
the infection resolves. Also, tell your doctor if you have any cuts or open wounds that
could 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(may affect up to 1 in 10 people)

• 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(may affect up to 1 in 100 people)

• Dental infections
• 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 small, yellow or white pustules, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• 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(may affect up to 1 in 10,000 people)

• 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, 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 Uzpruvo

• Uzpruvo 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.
• If necessary, an unopened vial can also be stored at room temperature up to 30°C for a single period of up to 7 days in the outer packaging in order to protect it from light. Once a vial has been stored at room temperature (up to 30°C), it must not be returned to the refrigerator. Discard the vial if not used within 7 days at room temperature or by the original expiry date, whichever is earlier.
• Do not shake the vials of Uzpruvo. 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 that month.
• If the liquid has a discoloured appearance, is cloudy or contains large particles floating in it (see section 6 “Description of Uzpruvo 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.

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

6. Package Contents and Other Information

What Uzpruvo contains

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

Description of Uzpruvo and package contents
Uzpruvo is a clear, colorless to pale yellow concentrate for infusion solution and
practically free from visible particles (sterile concentrate). It is supplied in a cardboard package
containing 1 single-dose vial made of 30 mL glass. Each vial contains 130 mg of
ustekinumab in 26 mL of concentrate for infusion solution (sterile concentrate).

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626

Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111

Magyarország
STADA Hungary Kft
Tel.: +36 18009747

Danmark
STADA Nordic ApS
Tlf: +45 44859999

Malta
Pharma.MT Ltd
Tel: +356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030

Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +370 52603926

Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
DEMO S.A. Pharmaceutical Industry
Τηλ: +30 2108161802

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850

España
Laboratorio STADA, S.L.
Tel: +34 934738889

Polska
STADA Pharm Sp. z.o o.
Tel: +48 227377920

France
EG LABO - Laboratoires EuroGenerics
Tél: +33 146948686

Portugal
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111

România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777

Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Arzneimittel AG
Sími: +49 61016030

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371

Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
DEMO S.A. Pharmaceutical Industry
Τηλ: +30 2108161802

Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +370 52603926
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.
Dilution instructions:
Uzpruvo 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 Uzpruvo vials needed based on the patient's weight (see section 3, Table 1). Each 26 mL vial of Uzpruvo contains 130 mg of ustekinumab.
• 2. Withdraw and discard a volume of sodium chloride 0.9% solution (from a 250 mL infusion bag) equal to the volume of Uzpruvo to be added (discard 26 mL of sodium chloride for each vial of Uzpruvo needed, for 2 vials discard 52 mL, for 3 vials discard 78 mL, for 4 vials discard 104 mL).
• 3. Withdraw 26 mL of Uzpruvo from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag must be 250 mL. Gently mix.
• 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 eight hours of dilution in the infusion bag.
• 6. Use only one sterile, non-pyrogenic, low-protein-binding in-line filter infusion set (pore size 0.2 micrometers).
• 7. Each vial is for single use and unused medicinal product must be disposed of in accordance with local regulations.

Storage
If necessary, the diluted infusion solution may be stored at room temperature.
The infusion must be completed within 8 hours of dilution in the infusion bag. Do not
freeze.

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

1. What is Uzpruvo and what is it used for

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

What is Uzpruvo used for
Uzpruvo 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.
Uzpruvo will reduce the inflammation and other signs of the disease.
Uzpruvo 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.
Uzpruvo 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 Uzpruvo to:

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

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 well enough or are intolerant to these
medicines, you may be given Uzpruvo to reduce the signs and symptoms of the disease.

2. What you need to know before using Uzpruvo

Do not use Uzpruvo

• 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 important.

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

Warnings and precautions
Talk to your doctor or pharmacist before using Uzpruvo. 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 Uzpruvo. If your doctor thinks you are at risk of tuberculosis, you
may be given medicines to treat tuberculosis.

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

Contact your doctor before using Uzpruvo

• If you have ever had an allergic reactionto Uzpruvo. Ask your doctor if you are not sure.
• If you have ever had any type of cancer- because immunosuppressants like Uzpruvo partially weaken the immune system. This may increase the risk of cancer.
• 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.
• If you have ever had any new or changed lesionwithin the area of psoriasis or on normal skin.
• If you are taking any other type of treatment for psoriasisand/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 Uzpruvo has not been studied. However, it is possible that it may increase the possibility of conditions related to a weakening of the immune system.
• If you are using or have ever used injections for the treatment of allergies- it is not known if Uzpruvo 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 if any of the conditions mentioned above may apply to you, talk to your doctor
or pharmacist before undergoing treatment with Uzpruvo.
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, 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 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 speech or vision abnormalities.

Children and adolescents
Uzpruvo is not recommended for the treatment of children with psoriasis under the age of 6, or for
the treatment of children and adolescents 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 Uzpruvo
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 Uzpruvo.
• if you received Uzpruvo during pregnancy, inform your child's pediatrician about the treatment with Uzpruvo before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Uzpruvo 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

• It is preferable to avoid the use of Uzpruvo during pregnancy. The effects of Uzpruvo on pregnant women are not known. If you are of childbearing potential, it is advisable to avoid becoming pregnant; you should use adequate contraception during the use of Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo. If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
• Ustekinumab can reach the unborn child through the placenta. If you have received Uzpruvo during pregnancy, your child may have an increased risk of infection.
• If you received Uzpruvo during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Uzpruvo 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 plan to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Uzpruvo. You cannot do both.

Driving and using machines
Uzpruvo does not impair or negligibly impairs the ability to drive vehicles or use machines.

Uzpruvo contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per ml. Polysorbates can cause
allergic reactions. Tell your doctor if you have known allergies.

3. How to use Uzpruvo

Uzpruvo is intended for use under the guidance and supervision of a physician experienced in the treatment of the conditions for which Uzpruvo 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 undergo the injections and subsequent follow-up
visits.

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

Adults starting from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended starting dose is 45 mg of Uzpruvo. 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 Uzpruvo will be administered to you by the doctor via an intravenous infusion in your arm (intravenous infusion). After the initial dose, you will receive the next dose of 90 mg of Uzpruvo after 8 weeks, then every 12 weeks with a subcutaneous injection (subcutaneous route).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Uzpruvo may be administered every 8 weeks. The 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 Uzpruvo 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 each dose.
• If the body weight is less than 60 kg, there is no dosage form of Uzpruvo for children weighing less than 60 kg.
• If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo.
• If the weight exceeds 100 kg, the recommended dose is 90 mg of Uzpruvo.
• After the initial dose, you will receive the next dose after 4 weeks, and subsequently every 12 weeks.

How Uzpruvo is administered

• Uzpruvo is administered by a subcutaneous injection (“by the subcutaneous route”). At the beginning of treatment, medical or nursing staff may inject Uzpruvo for you.
• However, you and your doctor can decide whether you can inject Uzpruvo yourself. In this case, you will be taught how to inject Uzpruvo yourself.
• For instructions on how to inject Uzpruvo, see “Instructions for Administration” at the end

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

If you use more Uzpruvo than you should
If you have used or received too much Uzpruvo, 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 Uzpruvo
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 Uzpruvo
It is not dangerous to stop using Uzpruvo. However, if you stop treatment, the symptoms may reappear.
If you have any doubts 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 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 receiving ustekinumab (may affect up to 1 in 1,000 people). 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 (may affect up to 1 in 100 people).

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 Uzpruvo again.

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

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

Uzpruvo 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 careful to watch for signs of infection while using Uzpruvo. 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 you urinate
• 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 infections such as chest infections, skin infections, herpes zoster or opportunistic infections that can have serious complications. See your doctor if you have any type of infection that persists or keeps coming back. Your doctor may decide to stop Uzpruvo until the infection gets better. Also tell your doctor if you have any cuts or open wounds that may get 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(may affect up to 1 in 10 people)

• 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(may affect up to 1 in 100 people)

• 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 palsy” or “Bell’s palsy”), which is usually temporary
• A change in psoriasis with redness and small, yellow or white bumps, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• 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(may affect up to 1 in 10,000 people)

• Blistering skin 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 Uzpruvo

• 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.
• Before administration, allow Uzpruvo to reach room temperature (approximately half an hour).
• If necessary, individual pre-filled syringes of Uzpruvo 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. Once removed from the refrigerator, record the date on which they should be discarded in the space 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. 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 that month.
• If the liquid has a change in colour, is cloudy or if it contains large particles floating (see section 6 “Description of Uzpruvo 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.

Uzpruvo is for single use. Any unused product remaining in the syringe must be discarded. Do not throw
any medicines down the drain or into household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Uzpruvo contains

• The active ingredient is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The other ingredients are: histidine, histidine monohydrochloride, polysorbate 80 (E433), sucrose, water for injections.

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

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

Manufacturers
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626

Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111

Magyarország
STADA Hungary Kft
Tel.: +36 18009747

Danmark
STADA Nordic ApS
Tlf: +45 44859999

Malta
Pharma.MT Ltd
Tel: +356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030

Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +370 52603926

Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
DEMO S.A. Pharmaceutical Industry
Τηλ: +30 2108161802

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850

España
Laboratorio STADA, S.L.
Tel: +34 934738889

Polska
STADA Pharm Sp. z.o o.
Tel: +48 227377920

France
EG LABO - Laboratoires EuroGenerics
Tél: +33 146948686

Portugal
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111

România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777

Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Arzneimittel AG
Sími: +49 61016030

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371

Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
DEMO S.A. Pharmaceutical Industry
Τηλ: +30 2108161802

Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +370 52603926

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 .
Detailed information on this medicinal product, including a video on how to use the pre-filled syringe,
is available by scanning the QR code below or the outer packaging with
a smartphone. The same information is also available at the following URL: uzpruvopatients.com
QR code to be included

Instructions for administration
INSTRUCTIONS FOR USE
Uzpruvo 45 mg solution for injection in pre-filled syringe
ustekinumab
for subcutaneous use
Read these instructions for use carefully before using Uzpruvo solution
for injection in pre-filled syringe
At the beginning of treatment, the doctor will assist you during the first injection. However, you and the doctor
may decide that you can inject Uzpruvo yourself. In this case, you will be taught how to inject
Uzpruvo yourself. Inform your doctor if you have any questions about the injection to be performed
yourself.

Important information you must know before injecting Uzpruvo solution for injection in
pre-filled syringe
Uzpruvo solution for injection in pre-filled syringe is not suitable for paediatric patients weighing less
than 60 kg, other ustekinumab-containing products that allow weight-based dosing must be used.

Important information:

• For subcutaneous use only
• Do not mix Uzpruvo with other injectable liquids
• Do not shake the pre-filled syringes of Uzpruvo. This is because shaking can damage the medicine. Do not use the medicine if it has been shaken vigorously. Take a new pre-filled syringe.

Check the pre-filled syringe to make sure 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 Uzpruvo or if your dose is 90 mg you will take two 45 mg pre-filled syringes of Uzpruvo and you will need to perform two injections. Choose two different body sites for these injections (e.g. 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 and from colourless to light yellow and practically free from visible particles
• the solution in the pre-filled syringe is not frozen
• it has reached room temperature (about half an hour).

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

Plunger Syringe body Needle Needle cap
Figure 1

1. Prepare the materials

Collect the necessary materials to prepare and administer the injection. You will need:

• Antiseptic swabs
• Cotton balls or gauze
• Adhesive bandage
• The prescribed dose of Uzpruvo (see Figure 1)
• Puncture-resistant sharps disposal container (not included). See Figure 2. Gather everything you need and place it on a clean surface.

Uzpruvo
Prefilled
Sharps
Wipes
syringe
container
Adhesive
bandage
Cotton
ball or gauze
Figure 2

2. Choose the injection site and prepare it

Choose a site for the injection (see Figure 3).

• Uzpruvo is administered by injection under the skin (subcutaneously)
• Choose an injection site. A good place for the injection is the upper thigh (legs), buttocks, or around the abdomen (belly) at least 5 cm away from the navel
• If someone assists you during the injection, you can also choose the upper arms (see figure 3)
• Use a different injection site for each injection. Do not make an injection in an area of skin that is sensitive, bruised, red, or hardened

The areas in yellow are the recommended sites for the injection
Figure 3
Prepare the injection site

• Wash your hands very well with soap and warm water.
• Rub the skin where you plan to make the injection with an antiseptic wipe
• Do not touch this area again before making the injection. Allow the skin to dry before the injection
• Do not air or blow on the cleaned area
• Do not inject through clothing

3. Remove the needle cap (see Figure 4):

• Hold the pre-filled syringe body with one hand and remove the needle cap when you are ready to inject Uzpruvo (see Figure 4)
• Do not touch the plunger while removing the needle cap
• Dispose of the needle cap in the trash. Do not replace the cap
• You may also see a drop of liquid at the tip of the needle. This is normal
• Do not touch the needle and avoid letting the needle touch anything
• Inject the dose immediately after removing the needle cap

Figure 4

4. Inject the dose

Grasp the syringe:

• Hold the body of the prefilled syringe with one hand between your thumb and index finger (see Figure 5)
• Do not use the prefilled syringe if it is removed without the needle protective cap in place. If this happens, contact your doctor or pharmacist for instructions
• Never pull back on the plunger

Figure 5
Pinch the skin and insert the needle:

• Use your other hand to gently pinch the clean area of skin. Hold firmly
• Using a quick, dart-like motion, insert the needle into the pinched skin at an angle of approximately 45 degrees (see Figure 6)

Figure 6
Inject the medicine:

• Inject all of the liquid by using your thumb to push the plunger all the way down until the prefilled syringe is empty (see Figure 7).

Figure 7
Let the needle retract:

• When the plunger is pushed all the way down, maintain pressure on the plunger head. Remove the needle from the skin and release the skin
• Slowly remove your thumb from the plunger head. The plunger will rise with your finger and retract the needle into the needle protection (see Figure 8).

Figure 8

5. After the injection

• After completing the injection, press a cotton ball or gauze on the injection site for a few seconds after the injection (see Figure 9)
• You may see slight bleeding at the injection site. This is normal
• Do not rub the skin at the injection site
• You can cover the injection site with a small bandage, if necessary

Figure 9

6 Disposal

• Place used syringes in a puncture-resistant container, such as a sharps container, immediately after use, according to local regulations (see Figure 10). Do not discard (dispose of) syringes in household waste
• Dispose of antiseptic wipes, cotton balls or gauze, and packaging in the trash
• Never reuse a syringe, for your own safety and health, and for that of others

Figure 10

Uzpruvo 90 mg solution for injection in pre-filled syringe

ustekinumab
Medicinal product subject to additional monitoring. This will allow for 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 Uzpruvo 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 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Uzpruvo and what is it used for

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

What is Uzpruvo used for
Uzpruvo 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.
Uzpruvo will reduce the inflammation and other signs of the disease.
Uzpruvo 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.
Uzpruvo 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 Uzpruvo 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 well enough or are intolerant to these
medicines, you may be given Uzpruvo to reduce the signs and symptoms of the disease.

2. What you need to know before using Uzpruvo

Do not use Uzpruvo

• 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 Uzpruvo.

Warnings and precautions
Talk to your doctor or pharmacist before using Uzpruvo. 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 Uzpruvo. If your doctor believes you are at risk of tuberculosis, you
may be given medicines to treat tuberculosis.

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

Contact your doctor before using Uzpruvo

• If you have ever had an allergic reactionto Uzpruvo. Ask your doctor if you are not sure.
• If you have ever had any type of cancer- this is because immunosuppressants like Uzpruvo weaken the immune system to some extent. This can increase the risk of cancer.
• 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.
• If you have ever had any new or changed lesionwithin the area of psoriasis or on normal skin.
• If you are taking any other type of treatment for psoriasisand/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 reduce the activity of the immune system to some extent. The simultaneous use of these therapies with Uzpruvo 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 Uzpruvo 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 if any of the conditions mentioned above may apply to you, talk to your doctor
or pharmacist before undergoing treatment with Uzpruvo.
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, 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 the body, facial drooping, or speech or vision abnormalities.

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

Other medicines, vaccines and Uzpruvo
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 Uzpruvo.
• if you received Uzpruvo during pregnancy, inform your child's pediatrician about the treatment with Uzpruvo before your child receives any vaccines, including live vaccines such as the BCG vaccine (used for the prevention of tuberculosis). If you received Uzpruvo 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

• It is preferable to avoid the use of Uzpruvo during pregnancy. The effects of Uzpruvo on pregnant women are not known. If you are of childbearing potential, you should avoid becoming pregnant; you should use adequate contraception during use of Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo.
• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice.
• Ustekinumab can reach the unborn child through the placenta. If you have received Uzpruvo during pregnancy, your child may be at increased risk of infection.
• If you received Uzpruvo during pregnancy, it is important to inform your pediatrician and other healthcare professionals before your child receives any vaccines. If you received Uzpruvo 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 small amounts into breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor for advice. You and your doctor will decide whether to breastfeed or use Uzpruvo. You cannot do both.

Driving and using machines
Uzpruvo does not impair or negligibly impairs the ability to drive vehicles or operate machinery.

Uzpruvo contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per ml. Polysorbates can cause
allergic reactions. Tell your doctor if you have known allergies.

3. How to use Uzpruvo

Uzpruvo is intended for use under the guidance and supervision of a doctor experienced in the treatment of the conditions for which Uzpruvo 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 undergo injections and subsequent follow-up visits.

How much Uzpruvo is administered
The doctor will decide how much Uzpruvo 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 Uzpruvo. 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 Uzpruvo will be administered to you by the 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 Uzpruvo 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 Uzpruvo may be administered every 8 weeks. The 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 Uzpruvo 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 each dose.
• If the body weight is less than 60 kg, there is no dosage form of Uzpruvo for children weighing less than 60 kg.
• If the body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo. If the weight exceeds 100 kg, the recommended dose is 90 mg of Uzpruvo.
• After the initial dose, you will need to receive the next dose after 4 weeks, and subsequently every 12 weeks.

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

• However, you and your doctor can decide whether you can inject Uzpruvo yourself. In this case, you will be taught how to inject Uzpruvo yourself.
• For instructions on how to inject Uzpruvo, see “Instructions for Use” at the end

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

If you use more Uzpruvo than you should
If you have used or received too much Uzpruvo, 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 Uzpruvo
If you forget a dose, contact your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

If you stop using Uzpruvo
It is not dangerous to stop using Uzpruvo. However, if you stop treatment, the symptoms may reappear.
If you have any doubts 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 everybody gets them.
li manifestino.

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

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

• Severe allergic reactions (“anaphylaxis”) are rare in patients taking ustekinumab (may affect up to 1 in 1,000 people). 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 skin rash and hives (may affect up to 1 in 100 people).

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 Uzpruvo
again.

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

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

Uzpruvo 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 careful to watch for signs of infection while using Uzpruvo. 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 you urinate
• 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 infections such as chest infections, skin infections, herpes zoster or opportunistic
infections that can have serious complications. See your doctor if you have any type of
infection that persists or keeps coming back. Your doctor may decide to stop Uzpruvo until
the infection is resolved. Also tell your doctor if you have any cuts or open wounds that
could 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(may affect up to 1 in 10 people)

• 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(may affect up to 1 in 100 people)

• Dental infection
• Vaginal fungal infection
• Depression
• Blocked 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 palsy” or “Bell’s palsy”), which is usually temporary
• A change in psoriasis with redness and small, yellow or white bumps, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• Acne

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

• 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 skin rash with small red or purple bumps, fever or joint pain (vasculitis)

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

• Blistering skin 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 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 Uzpruvo

• 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.
• Before administration, allow Uzpruvo to reach room temperature (approximately half an hour).
• If necessary, individual pre-filled syringes of Uzpruvo 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. Once removed from the refrigerator for the first time, record the date on which they should be discarded in the space 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. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and the outer packaging after EXP or Scad. The expiry date refers to the last day of that month.
• If the liquid has a change in colour, is cloudy or contains large particles floating in it (see section 6 “Description of Uzpruvo 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.

Uzpruvo is for single use. Any unused product remaining in the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Uzpruvo contains

• The active ingredient is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The other ingredients are: Histidine, histidine monohydrochloride, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Uzpruvo and contents of the pack
Uzpruvo is a clear, injectable solution, from colourless to slightly yellow and practically free from
visible particles. It is supplied in a carton containing 1 or 2 single-dose, pre-filled glass syringes of 1 mL. Each pre-filled syringe contains a dose of ustekinumab 90 mg in
1 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany

Manufacturers
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626

Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111

Magyarország
STADA Hungary Kft
Tel.: +36 18009747

Danmark
STADA Nordic ApS
Tlf: +45 44859999

Malta
Pharma.MT Ltd
Tel: +356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030

Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +370 52603926

Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
DEMO S.A. Pharmaceutical Industry
Τηλ: +30 2108161802

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850

España
Laboratorio STADA, S.L.
Tel: +34 934738889

Polska
STADA Pharm Sp. z.o o.
Tel: +48 227377920

France
EG LABO - Laboratoires EuroGenerics
Tél: +33 146948686

Portugal
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111

România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777

Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Arzneimittel AG
Sími: +49 61016030

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371

Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
DEMO S.A. Pharmaceutical Industry
Τηλ: +30 2108161802

Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +370 52603926

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 .
Detailed information on this medicinal product, including a video on how to use the pre-filled syringe, is available by scanning the QR code below or the outer packaging with
a smartphone. The same information is also available at the following URL: uzpruvopatients.com
QR code to be included

Instructions for administration
INSTRUCTIONS FOR USE
Uzpruvo 90 mg solution for injection in pre-filled syringe
ustekinumab
for subcutaneous use
Read these instructions for use carefully before using Uzpruvo solution
for injection in pre-filled syringe
At the beginning of treatment, your doctor will assist you during the first injection. However, you and your doctor
may decide that you can inject Uzpruvo yourself. In this case, you will be taught how to inject
Uzpruvo yourself. Inform your doctor if you have any questions about the injection to be performed
yourself.

Important information you should know before injecting Uzpruvo solution for injection in
pre-filled syringe
Uzpruvo solution for injection in pre-filled syringe is not suitable for paediatric patients weighing less
than 60 kg, other ustekinumab products that allow weight-based dosing should be used.

Important information:

• For subcutaneous use only
• Do not mix Uzpruvo with other injectable liquids
• Do not shake the pre-filled syringes of Uzpruvo. This is because shaking can damage the medicine. Do not use the medicine if it has been shaken vigorously. Take a new pre-filled syringe.

Check the pre-filled syringe to make sure that:

• the number of pre-filled syringes and the dose are correct or if your dose is 90 mg you will take one 90 mg pre-filled syringe of Uzpruvo
• 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 and from colourless to light yellow and practically free from visible particles
• the solution in the pre-filled syringe has not been frozen
• it has reached room temperature (about half an hour).

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

Plunger Syringe body Needle Needle cap
Figure 1

1. Prepare the materials

Gather the necessary materials to prepare and administer the injection. You will need:

• Antiseptic wipes
• Cotton balls or gauze
• Adhesive bandage
• The prescribed dose of Uzpruvo (see Figure 1)
• Puncture-resistant sharps disposal container (not included). See Figure 2. Take everything you need and place it on a clean surface.

Uzpruvo
Prefilled
Sharps
Wipes
syringe
container
Adhesive
bandage
Cotton ball
or gauze
Figure 2

2. Choose the injection site and prepare it

Choose an injection site (see Figure 3).

• Uzpruvo is administered by injection under the skin (subcutaneously)
• Choose an injection site. A good place for the injection is the upper thigh (legs), buttocks, or around the abdomen (belly) at least 5 cm away from the navel
• If someone assists you during the injection, you can also choose the upper arms (see figure 3)
• Use a different injection site for each injection. Do not make an injection in an area of skin that is sensitive, bruised, red, or hardened

The areas in yellow are the recommended sites for the injection
Figure 3
Prepare the injection site

• Wash your hands thoroughly with soap and warm water.
• Rub the skin where you plan to make the injection with an antiseptic swab
• Do not touch this area again before making the injection. Let the skin dry before the injection
• Do not fan or blow on the cleaned area
• Do not inject through clothing

3. Remove the needle cap (see Figure 4):

• Hold the pre-filled syringe body with one hand and remove the needle cap when you are ready to inject Uzpruvo (see Figure 4)
• Do not touch the plunger while removing the needle cap
• Dispose of the needle cap in the trash. Do not replace the cap
• You may also see a drop of liquid at the end of the needle. This is normal
• Do not touch the needle and avoid letting the needle touch anything
• Inject the dose immediately after removing the needle cap

Figure 4

4. Inject the dose

Grasp the syringe:

• Hold the body of the prefilled syringe with one hand between your thumb and index finger (see Figure 5)
• Do not use the prefilled syringe if it is pulled out without the needle protective cap in place. If this happens, contact your doctor or pharmacist for instructions
• Never pull back on the plunger

Figure 5
Pinch the skin and insert the needle:

• Use your other hand to gently lift the cleaned area of skin. Hold firmly
• Use a quick, dart-like motion to insert the needle into the lifted skin at an angle of approximately 45 degrees (see Figure 6)

Figure 6
Inject the medicine:

• Inject all of the liquid by using your thumb to push the plunger all the way down until the prefilled syringe is empty (see Figure 7).

Figure 7
Allow the needle to retract:

• When the plunger is pushed all the way down, maintain pressure on the plunger head. Remove the needle from the skin and release the skin
• Slowly remove your thumb from the plunger head. The plunger will rise with your finger and retract the needle into the needle protection (see Figure 8).

Figure 8

5. After the injection

• After completing the injection, position a cotton ball or gauze on the injection site for a few seconds after the injection (see Figure 9)
• You may see slight bleeding at the injection site. This is normal
• Do not rub the skin at the injection site
• You can cover the injection site with a small bandage, if necessary

Figure 9

6 Disposal

• Dispose of used syringes in a puncture-resistant container, such as a sharps container, immediately after use, according to local regulations (see Figure 10). Do not discard (dispose of) syringes in household waste
• Dispose of antiseptic swabs, cotton balls or gauze and packaging in the trash
• Never reuse a syringe, for your own safety and health, and for that of others

Figure 10