Uzpruvo

Package leaflet: Information for the user

Uzpruvo 130 mg concentrate for solution for infusion

ustekinumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
This leaflet has been written for people 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 get any side effects, including those not listed in this leaflet, talk to 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 Uzpruvo will be used
4. Possible side effects
5. How to store Uzpruvo
6. Contents of the pack and other information

1. What Uzpruvo is and what it is used for

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

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

• Moderate to severe Crohn’s disease in adults and children weighing at least 40 kg.

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

2. What you should know before using Uzpruvo

Do not use Uzpruvo

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Uzpruvo.
Warnings and precautions
Talk to your doctor or pharmacist before using Uzpruvo. Your doctor will assess your health status before starting treatment. Make sure to inform your doctor about any medical conditions you have before treatment. Also, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Uzpruvo. If your doctor believes you are at risk for tuberculosis, you may be given 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.
Before using Uzpruvo, contact your doctor

• If you have ever had an allergic reaction to Uzpruvo – Ask your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants such as Uzpruvo partially weaken the immune system. This may increase the risk of cancer.
• If you have been treated for psoriasis with other biological 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 recently had an infection or if you have abnormal openings in the skin (fistulas).
• If you have ever had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other 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 may also partially reduce immune system activity. The concomitant use of these therapies with Uzpruvo has not been studied. However, it may increase the likelihood of conditions related to a weakened immune system.
• If you are using or have ever used injections for allergy treatment – it is not known whether Uzpruvo may affect them.
• If you are aged 65 years or older – you may have an increased risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Uzpruvo.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or an unusual sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Uzpruvo is not recommended for the treatment of children weighing less than 40 kg with Crohn’s disease, as it has not been studied in this age group.
Other medicines, vaccines, and Uzpruvo
Inform your doctor or pharmacist

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

Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are of childbearing potential, it is advisable to avoid becoming pregnant and you should use an effective method of contraception during treatment with Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Uzpruvo during pregnancy, your child may have an increased risk of developing infections.
• If you received Uzpruvo during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Uzpruvo during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Uzpruvo. You cannot do both.

Driving and using machines
Uzpruvo has no effect or a negligible effect on the ability to drive vehicles or operate machinery.
Uzpruvo contains sodium and polysorbate 80
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially ‘sodium-free’. However, before Uzpruvo is administered, it is mixed with a solution containing sodium. Speak with your doctor if you are on a low-salt diet.
This medicine contains 0.4 mg of polysorbate 80 per ml. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Uzpruvo will be used

Uzpruvo is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease.
Your doctor will administer Uzpruvo 130 mg concentrate for solution for infusion to you as an intravenous infusion (a drip into a vein in your arm) lasting at least one hour. Discuss with your doctor when you should receive your injections and follow-up visits.

How much Uzpruvo will be administered

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

Adults from 18 years of age

• Your doctor will calculate the recommended intravenous infusion dose based on your body weight.

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 receive the next dose of 90 mg of Uzpruvo as an injection under the skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.

Children with Crohn’s disease weighing at least 40 kg

• Your doctor will calculate the recommended intravenous infusion dose based on body weight.

Body weight Dose
≥ 40 to ≤ 55 kg 260 mg

 55 kg to ≤ 85 kg 390 mg
 85 kg 520 mg

• 8 weeks after the initial intravenous dose, you will receive the next dose of 90 mg of Uzpruvo as a subcutaneous injection (injection under the skin), then every 12 weeks thereafter.

How Uzpruvo is administered

• The first dose of Uzpruvo for the treatment of Crohn’s disease is administered by your doctor as an intravenous infusion (a drip into a vein in your arm). Inform your doctor if you have any questions about how to use Uzpruvo.

If you forget to use Uzpruvo

If you forget or miss your scheduled dose appointment, contact your doctor to reschedule as soon as possible.

If you stop using Uzpruvo

Stopping treatment with Uzpruvo is not dangerous. However, if you stop treatment, your symptoms may return.

If you have any questions about the use of this medicine, consult 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 immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in patients taking ustekinab (may affect up to 1 in 1,000 people). Signs include:

  • difficulty breathing or swallowing, or low blood pressure, which may cause dizziness or a feeling of lightheadedness
  • 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, your first dose of Uzpruvo is given via an intravenous infusion (drip). 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. Inform 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.

• Nasal, throat infections and 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 skin and underlying 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 reduce your body’s 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 mainly occur 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 alert for signs of infection while taking Uzpruvo. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath, persistent cough
• warmth, redness, pain or a painful blistering rash on the skin
• burning sensation when urinating
• diarrhoea
• vision problems or loss of vision
• headache, neck stiffness, sensitivity to light, nausea or confusion

Contact your doctor immediately if you notice any of these signs of infection. These may be symptoms of infections such as chest infections, skin infections, herpes zoster or opportunistic infections, which can have serious complications. Speak to your doctor if you have any infection that persists or keeps coming back. Your doctor may decide to stop Uzpruvo until the infection has resolved. Also inform 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 must inform your doctor immediately.

Other side effects

Common side effects (may affect up to 1 in 10 people)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• 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
• 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 paralysis” or “Bell’s palsy”), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, 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 of psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause 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)

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

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 solution for infusion is administered in a hospital or clinic setting, 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 may also be stored at room temperature up to 30°C for a single period of up to 7 days within the outer packaging 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 comes first.

• Do not shake Uzpruvo vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after “Exp”. The expiry date refers to the last day of that month.
• If the liquid has changed colour, is cloudy, or contains large floating particles (see section 6 “Description of the appearance of Uzpruvo and contents of the container”).
• If you know or suspect 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 only. Any unused diluted infusion solution or unused product remaining in the vial and syringe must be discarded 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 components are: disodium edetate dihydrate, histidine, monohydrochloride histidine, methionine, polysorbate 80 (E433), sucrose and water for injections.

Description of the appearance of Uzpruvo and contents of the pack
Uzpruvo is a clear, colourless to pale yellow concentrate for infusion solution, practically free from visible particles (sterile concentrate). It is supplied in a cardboard pack containing one single dose in a 30 mL glass vial. 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
Manufacturers
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 24797878 Tel: +370 52603926
България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 24797878
Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009747
Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008
Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000
Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +372 53072153 Tlf: +45 44859999
Ελλάδα Österreich
DEMO S.A. Pharmaceutical Industry STADA Arzneimittel GmbH
Τηλ: +30 2108161802 Tel: +43 136785850
España Polska
Laboratorio STADA, S.L. STADA Pharm Sp. z o.o.
Tel: +34 934738889 Tel: +48 227377920
France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870
Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640
Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710
Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933
Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888
Κύπρος Sverige
DEMO S.A. Pharmaceutical Industry STADA Nordic ApS
Τηλ: +30 2108161802 Tel: +45 44859999
Latvija
UAB „STADA Baltics“
Tel: +371 28016404
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 medicinal products, the trade name and batch number of the administered product must be clearly recorded.
Instructions for dilution:
Uzpruvo concentrate for infusion solution must be diluted, prepared and administered by a healthcare professional using aseptic technique.

1. Calculate the dose and number of Uzpruvo vials required based on the patient's body weight (see section 3, Table 1, Table 2). Each 26 mL vial of Uzpruvo contains 130 mg of ustekinumab.
2. Withdraw and discard a volume of 0.9% sodium chloride solution (9 mg/mL) from the 250 mL infusion bag equal to the volume of Uzpruvo to be added (discard 26 mL of sodium chloride for each required Uzpruvo vial; 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 required vial 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, discolouration 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 a single infusion set with an in-line sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometres).
7. Each vial is for single use only and any 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 after dilution in the infusion bag. Do not freeze.

Patient Information Leaflet: Instructions for the User

Uzpruvo 45 mg solution for injection

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for the rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are a parent or caregiver of a child who needs to be given Uzpruvo, please 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 Uzpruvo is and what it is used for

What Uzpruvo is
Uzpruvo contains the active substance "ustekinumab", a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind to specific proteins 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 Uzpruvo is used for
Uzpruvo is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails. Uzpruvo will reduce inflammation and other signs of the disease.
Uzpruvo is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate or phototherapy, or in whom these treatments are ineffective.
Uzpruvo is used in children and adolescents 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 joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given 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 bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Uzpruvo may be given 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 ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with 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 inform your doctor, before each treatment, about any medical
conditions you have. In addition, inform your doctor if you have recently been in contact with people
who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis
before administering Uzpruvo. If your doctor believes you are at risk of tuberculosis, you may be given
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 full
list of these side effects.
Before using Uzpruvo, contact your doctor

• If you previously had an allergic reaction to Uzpruvo. Ask your doctor if you are unsure.
• If you previously 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 biological 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 recently had an infection.
• If you have had any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other 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 may also partially reduce immune system activity. The concomitant use of these therapies with Uzpruvo has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.
• If you are using or have previously used allergy injections – it is not known whether Uzpruvo may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or
pharmacist before starting treatment with Uzpruvo.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in areas of skin exposed to sunlight, or if you experience joint pain.
Heart attack and stroke
In a study of psoriasis patients treated with ustekinumab, heart attack and stroke were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Uzpruvo is not recommended for the treatment of children under 6 years of age with psoriasis, for children with Crohn’s disease weighing less than 40 kg, or for children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines and Uzpruvo
Inform 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) must not be administered while you are using Uzpruvo.
• If you received Uzpruvo during pregnancy, inform your child’s paediatrician about the Uzpruvo treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Uzpruvo during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Uzpruvo during pregnancy, your child may have an increased risk of developing an infection.
• If you received Uzpruvo during pregnancy, it is important that you inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Uzpruvo during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or plan to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Uzpruvo. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has a negligible effect on the ability to drive vehicles or operate
machinery.
Uzpruvo contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform 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 exactly as prescribed by your doctor. If you have any doubts, consult your
doctor. Discuss with your doctor when you should receive injections and follow-up visits.
How much Uzpruvo is administered
Your doctor will decide how much Uzpruvo you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Uzpruvo. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration 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 is administered by your doctor via intravenous infusion (into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Uzpruvo after 8 weeks, followed by administration every 12 weeks via subcutaneous injection (under the skin).
• In some patients, after the first subcutaneous injection, the 90 mg dose of Uzpruvo may be administered every 8 weeks. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Uzpruvo to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time each dose is given.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Uzpruvo per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Uzpruvo.
• Four weeks after the initial dose, the next dose should be administered, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

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

How Uzpruvo is administered

• Uzpruvo is administered by subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Uzpruvo to you.
• However, you and your doctor may decide whether you can self-inject Uzpruvo. In this case, you will be trained on how to self-inject Uzpruvo.
• For instructions on how to inject Uzpruvo, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

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 miss 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
Stopping treatment with Uzpruvo is not dangerous. However, if you stop treatment, your disease
symptoms may return.
If you have any questions about the use of this medicine, consult 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 emergency 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: difficulty breathing or swallowing, low blood pressure causing dizziness or lightheadedness, or 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. Inform your doctor immediately if you develop symptoms such as cough, shortness of breath, or fever.
If you experience 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.

• 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 tissue beneath the skin ("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 reduce 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 primarily occur 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 aware of the signs of infection while using Uzpruvo. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or short of breath; persistent cough
• warmth, redness, pain, or a painful blistering rash on the skin
• burning sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, light sensitivity, 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, which may have serious complications. Contact your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Uzpruvo until the infection resolves. Also inform 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, inform your doctor immediately.

Other side effects

Common side effects (may affect up to 1 in 10 people)

• Diarrhoea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• 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
• 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 paralysis" or "Bell's palsy"), which is usually temporary
• A change in psoriasis with redness and new small yellow or white blisters, 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 may 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)

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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 vial in the outer packaging to protect the medicine from light.
• Do not shake the vials. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Scad. The expiry date refers to the last day of that month.
• If the liquid changes colour, becomes cloudy, or if foreign particles are visible floating in it (see section 6 "Description of the appearance of Uzpruvo and contents of the pack").
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or heated).
• If the product has been vigorously shaken.

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

6. Contents of the pack and other information

What Uzpruvo contains

• The active substance is ustekinumab. Each vial contains 45 mg of ustekinumab in 0.5 mL.
• The other components 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, colourless to slightly yellow solution for injection, practically free from visible particles. It is supplied in a cardboard pack containing 1 single dose in a 2 mL glass vial. Each vial contains a single dose of 45 mg ustekinumab in 0.5 mL of injectable solution.

Marketing Authorization 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, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 24797878 Tel: +370 52603926

България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 24797878

Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009747

Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008

Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000

Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +372 53072153 Tlf: +45 44859999

Ελλάδα Österreich
DEMO S.A. Pharmaceutical Industry STADA Arzneimittel GmbH
Τηλ: +30 2108161802 Tel: +43 136785850

España Polska
Laboratorio STADA, S.L. STADA Pharm Sp. z o.o.
Tel: +34 934738889 Tel: +48 227377920

France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870

Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640

Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710

Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933

Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888

Κύπρος Sverige
DEMO S.A. Pharmaceutical Industry STADA Nordic ApS
Τηλ: +30 2108161802 Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +371 28016404

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

Instructions for administration
At the beginning of treatment, your doctor or a healthcare professional will assist you with the first injection. However, you and your doctor may decide whether you can self-inject Uzpruvo. In this case, you will be taught how to self-administer Uzpruvo. Inform your doctor if you have any questions regarding self-injection.

• Do not mix Uzpruvo with other injectable liquids.
• Do not shake the Uzpruvo vials, as vigorous shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare materials:

Remove one or more vials from the refrigerator. Leave the vial(s) outside the refrigerator for about
half an hour. This will allow the liquid to reach the appropriate temperature for injection
(room temperature).
Check the following:

• the number of vials and the dose are correct; if your dose is equal to or less than 45 mg, you will take one 45 mg Uzpruvo vial; if your dose is 90 mg, you will take two 45 mg Uzpruvo vials and will need to administer two injections. Choose two different body areas for these injections (for example, one injection in the right thigh and the other injection in the left thigh) and perform the injections one after the other. Use a new needle and a new syringe for each injection.
• the medicine is the correct one
• the medicine has not expired
• the vial is not damaged and the cap is not broken
• the solution in the vial is clear or slightly opalescent (pearl-like appearance) and colourless or pale yellow
• the liquid does not have a changed or cloudy colour and does not contain foreign particles
• the liquid has not been frozen.

Children with paediatric psoriasis and a body weight below 60 kg require a dose lower than 45 mg. Ensure the appropriate amount (volume) to withdraw from the vial and the type of syringe needed for dosing. If you do not know the amount of medicine or the type of syringe to use, contact your doctor for further instructions.
Gather all necessary supplies and place them on a clean surface. The supplies should include a syringe, needle, antiseptic wipes, cotton ball or gauze, and a sharps container (see Figure 1).

Figure 1

2. Choosing and preparing the injection site:

Choose an injection site (see Figure 2).

• Uzpruvo is administered by injection under the skin (subcutaneously).
• Recommended injection sites include the upper thigh or the area around the stomach (abdomen), at least 5 cm away from the navel.
• If possible, avoid areas of skin affected by psoriasis.
• If someone is assisting you with the injection, the upper arms or buttocks may also be used as injection sites.

* The areas in yellow are the recommended injection sites
Figure 2
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the injection site on the skin with an antiseptic swab.
• Do not touch this area again before administering the injection.

3. Prepare the dose:

• Remove the cap from the top of the vial (see Figure 3)

Figure 3

• Do not remove the stopper
• Clean the stopper with an antiseptic swab
• Place the vial on a flat surface
• Take the syringe and remove the protective needle cap
• Do not touch the needle, and do not let the needle touch anything
• Push the needle through the rubber stopper
• Turn the vial and syringe upside down while keeping the needle inserted
• Pull back the syringe plunger to draw up the prescribed amount of liquid, as directed by your doctor
• It is important that the needle remains fully immersed in the liquid to prevent air bubbles from entering the syringe (see Figure 4)

Figure 4

• Remove the needle from the vial
• Hold the syringe with the needle pointing upward to check for any air bubbles inside
• If air bubbles are present, gently tap the side of the syringe until the air bubbles rise to the top of the syringe (see Figure 5)

Figure 5

• Then gently push the plunger to expel all air (but not the liquid)
• Do not place the syringe on any surface and avoid letting the needle touch anything

4. Inject the dose:

• Gently pinch the clean area of skin, holding it between your thumb and index finger. Do not pinch too forcefully
• Insert the needle into the pinched skin
• Push the plunger with your thumb until all the liquid is injected. Press slowly and steadily, continuing to hold the skin pinched gently
• When the plunger reaches the end of the syringe, withdraw the needle and release the skin

5. After the injection:

• Press a sterile swab on the injection site for a few seconds after the injection
• A small amount of blood or fluid leakage at the injection site may occur. This is normal
• You may place a cotton ball or gauze pad on the injection site and press for 10 seconds
• Do not rub the skin at the injection site: you may cover the area with a small plaster, if needed

6. Disposal:

• Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your safety and the safety of others, never reuse needles or syringes. Dispose of the sharps container according to local regulations.
• Empty vials, antiseptic swabs, and other devices may be discarded in household waste.

Instructions for the user: leaflet information

Uzpruvo 45 mg solution for injection in a pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.
This leaflet has been written for people who are taking this medicine. If you are a parent or caregiver of a child who needs to be given Uzpruvo, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult 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 using 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 Uzpruvo is and what it is used for

What Uzpruvo is
Uzpruvo contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins 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 Uzpruvo is used for
Uzpruvo is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Uzpruvo will reduce inflammation and other signs of the disease.
Uzpruvo is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate or phototherapy, or in whom these treatments have not worked.
Uzpruvo is used in children and adolescents 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 been effective.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given 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 bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Uzpruvo may be given 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 ustekinumab or to any of the other ingredients of this medicine (listed in section 6 below).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions listed above apply to you, speak with 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 inform your doctor about any medical conditions you have before each treatment. Also, inform your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Uzpruvo. If your doctor believes you are at risk for tuberculosis, you may be given medicines to treat tuberculosis.
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.
Before using Uzpruvo, contact your doctor

• If you previously had an allergic reaction to Uzpruvo. Ask your doctor if you are unsure.
• If you previously had any type of cancer – because immunosuppressants like Uzpruvo partially weaken the immune system, which may increase the risk of cancer.
• If you have been treated for psoriasis with other biological 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 recently had an infection.
• If you have developed any new or changed skin lesions within the area of psoriasis or on normal skin.
• If you are currently receiving any other 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 may also partially reduce immune system activity. The concomitant use of these therapies with Uzpruvo has not been studied. However, it could increase the likelihood of conditions related to immune system weakening.
• If you are currently using or have previously used allergy injections – it is not known whether Uzpruvo may affect them.
• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before starting treatment with Uzpruvo.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, in sun-exposed areas of skin or if you experience joint pain.
Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on one side of the body, facial drooping, or speech or vision problems.
Children and adolescents
Uzpruvo is not recommended for the treatment of children under 6 years of age with psoriasis, for children with Crohn’s disease weighing less than 40 kg, or for children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.
Other medicines, vaccines, and Uzpruvo
Inform 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 scheduled to be vaccinated. Some types of vaccines (live vaccines) should not be administered while you are using Uzpruvo.
• if you received Uzpruvo during pregnancy, inform your child’s paediatrician about the Uzpruvo treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Uzpruvo during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
• In newborns exposed to ustekinumab in utero, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant; you should use an effective method of contraception during treatment with Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo.
• Ustekinumab can cross the placenta and reach the unborn child. If you received Uzpruvo during pregnancy, your child may have an increased risk of developing an infection.
• If you received Uzpruvo during pregnancy, it is important to inform your child’s paediatrician and other healthcare providers before your child receives any vaccine. If you received Uzpruvo during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your child during the first twelve months after birth, unless otherwise recommended by the paediatrician.
• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Uzpruvo. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.
Uzpruvo contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform 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 exactly as instructed by your doctor. If you have any doubts, consult your
physician. Discuss with your doctor when you should receive injections and follow-up visits.
How much Uzpruvo is administered
Your doctor will decide how much Uzpruvo you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Uzpruvo. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by administration 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 is administered by your doctor via an intravenous infusion into your arm. After the initial dose, you will receive a dose of 90 mg of Uzpruvo after 8 weeks, then every 12 weeks via 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. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Uzpruvo to be injected to ensure the correct dose is administered. The correct dose will depend on the child’s body weight at the time of each dose administration.
• For children and adolescents requiring a dose lower than 45 mg, a 45 mg vial is available.
• If body weight is less than 60 kg, the recommended dose is 0.75 mg of Uzpruvo per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Uzpruvo.
• Four weeks after the initial dose, you will receive the next dose, followed by administration every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Uzpruvo is administered by your doctor via an intravenous infusion into the arm. Eight weeks after the initial dose, you will receive the next dose of 90 mg of Uzpruvo, followed by administration every 12 weeks via 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. Your doctor will decide when the next dose should be administered.

How Uzpruvo is administered

• Uzpruvo is administered via subcutaneous injection (“subcutaneously”). At the beginning of treatment, medical or nursing staff may administer Uzpruvo to you.
• However, you and your doctor may decide whether you can self-inject Uzpruvo. In this case, you will be taught how to self-inject Uzpruvo.
• For instructions on how to inject Uzpruvo, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

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 miss 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
Stopping Uzpruvo is not dangerous. However, if you stop treatment, disease symptoms may return.
If you have any doubts about using this medicine, consult 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 assistance 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: difficulty breathing or swallowing, low blood pressure (which may cause dizziness or lightheadedness), or 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. 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 Uzpruvo again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice
any of the following signs.

• Nasal, throat infections, and 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 skin and underlying 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 reduce the ability to fight infections. Some infections may become severe and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur 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 aware of signs of infection while using Uzpruvo. 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 sensation when urinating
• diarrhea
• vision problems or loss of vision
• headache, neck stiffness, light sensitivity, 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, which may have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Uzpruvo 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, inform your doctor immediately.
Other side effects
Common side effects (may affect up to 1 in 10 people)

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• 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 new small yellow or white blisters, 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 may cause a rash with small red or purple spots, fever, or joint pain (vasculitis)

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult 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 30 minutes).
• If necessary, individual pre-filled syringes of Uzpruvo may be stored at room temperature up to 30°C for a single period of up to 30 days, kept in the outer packaging to protect from light. Once removed from the refrigerator, record the date by which they must 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 comes first.
• Do not shake the pre-filled syringes. Vigorous and prolonged shaking may damage the medicine.

Do not use this medicine

• After the expiry date stated on the label and carton after EXP or Scad. The expiry date refers to the last day of that month.
• If the liquid changes colour, appears cloudy, or if foreign particles are visible floating in it (see section 6 “Description of the appearance of Uzpruvo and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

Uzpruvo is for single use only. Any unused product remaining in the syringe must be discarded. Do not dispose of medicines via 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 substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 mL.
• The other components are: histidine, monohydrochloride histidine, polysorbate 80 (E433), sucrose, water for injections.

Description of the appearance of Uzpruvo and contents of the pack
Uzpruvo is a clear, colourless to slightly yellow injectable solution, practically free from visible particles. It is supplied in a cardboard pack containing one single dose in a 1 mL glass pre-filled syringe. Each pre-filled syringe contains a single dose of 45 mg ustekinumab in 0.5 mL of injectable solution.
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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 24797878 Tel: +370 52603926
България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 24797878
Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009747
Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008
Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000
Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +372 53072153 Tlf: +45 44859999
Ελλάδα Österreich
DEMO S.A. Pharmaceutical Industry STADA Arzneimittel GmbH
Τηλ: +30 2108161802 Tel: +43 136785850
España Polska
Laboratorio STADA, S.L. STADA Pharm Sp. z.o o.
Tel: +34 934738889 Tel: +48 227377920
France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870
Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640
Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710
Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933
Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888
Κύπρος Sverige
DEMO S.A. Pharmaceutical Industry STADA Nordic ApS
Τηλ: +30 2108161802 Tel: +45 44859999
Latvija
UAB „STADA Baltics“
Tel: +371 28016404
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 included below or on 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, your doctor or healthcare professional will assist you with your first injection.
However, you and your doctor may decide that you can self-inject Uzpruvo. In this case, you will be taught how to self-inject Uzpruvo. Inform your doctor if you have any questions about self-injection.
Important information:

• For subcutaneous use only
• Do not mix Uzpruvo with other injectable liquids
• Do not shake the pre-filled syringes of Uzpruvo, as shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously. Use a new pre-filled syringe instead.

Check the pre-filled syringe to ensure that:

• the number of pre-filled syringes and the dose are correct; if your dose is 45 mg, you will use one 45 mg pre-filled syringe of Uzpruvo; if your dose is 90 mg, you will use two 45 mg pre-filled syringes of Uzpruvo and will need to give yourself two injections. Choose two different body areas for these injections (e.g., one injection in the right thigh and the other in the left thigh), and perform 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, colourless to slightly yellow, and practically free from visible particles
• the solution in the pre-filled syringe has not been frozen
• the solution has reached room temperature (approximately 30 minutes).

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

Plunger Barrel of syringe Needle Needle cap
Figure 1

1. Prepare the materials:

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

• Antiseptic wipes
• Cotton balls or gauze pads
• Adhesive bandage
• The prescribed dose of Uzpruvo (see Figure 1)
• Puncture-resistant sharps container for disposal (not included). See Figure 2

Collect all supplies and place them on a clean surface.

Figure 2

2. Choose and prepare the injection site:

Choose an injection site (see Figure 3).

• Uzpruvo is administered by injection under the skin (subcutaneously)
• Select an injection site. Suitable areas of the body for injection are the upper thigh or around the abdomen (abdominal area), at least 5 cm away from the navel
• If someone is assisting you with the injection, you may also choose the upper arms or buttocks (see Figure 3)
• Use a different injection site for each injection. Do not inject into areas of skin that are tender, bruised, red, or hard

The yellow areas indicate recommended injection sites
Figure 3
Preparing the injection site

• Wash your hands thoroughly with soap and warm water
• Clean the skin where you plan to give the injection with an antiseptic wipe
• Do not touch this area again before giving the injection. Allow the skin to dry before injecting
• Do not fan or blow on the cleaned area
• Do not inject through clothing

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

• When you are ready to inject Uzpruvo, remove the needle cap
• Do not touch the plunger while removing the needle cap
• Hold the pre-filled syringe body with one hand and pull off the needle cap (see Figure 4)
• Dispose of the needle cap in the trash. Do not re-cap it
• 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:

Hold the syringe:

• Hold the pre-filled syringe body in one hand between thumb and index finger (see Figure 5)
• Do not use the pre-filled syringe if it does not have the needle protective cap. If this occurs, contact your doctor or pharmacist for instructions
• Never pull back the plunger

Figure 5
Pinch the skin and insert the needle:

• Use the other hand to gently pinch the cleaned area of skin and hold it firmly
• Use a quick, dart-like motion to insert the needle into the skin at an angle of approximately 45 degrees, while keeping the skin pinched (see Figure 6)

Figure 6
Inject the medicine:

• Inject all the liquid by using the thumb to push the plunger all the way down until the pre-filled syringe is empty (see Figure 7)

Figure 7
Allow the needle to retract:

• When the plunger is fully depressed, maintain pressure on the plunger head. Remove the needle from the skin and release the skin
• Slowly remove the thumb from the plunger head. The plunger will rise with the finger, retracting 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 pad over the injection site for a few seconds (see Figure 9).
• You may notice slight bleeding at the injection site. This is normal.
• Do not rub the skin at the injection site.
• You may cover the injection site with a small adhesive bandage, if needed.

Figure 9
6 Disposal:

• Immediately after use, place used syringes into a puncture-resistant container, such as a sharps container, in accordance with local regulations. Do not dispose of syringes in household waste (see Figure 10).
• 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 the safety of others.

Figure 10

Package leaflet: Information for the user

Uzpruvo 90 mg solution for injection in pre-filled syringe

ustekinumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.
This leaflet is intended for people taking this medicine. If you are a parent or caregiver of a child who is to be given Uzpruvo, please read these instructions carefully before administration.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult 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 using 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 Uzpruvo is and what it is used for

What Uzpruvo is
Uzpruvo contains the active substance “ustekinumab”, a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and bind to specific proteins 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 Uzpruvo is used for
Uzpruvo is used to treat the following inflammatory diseases:

• plaque psoriasis (in adults and children from 6 years of age)
• psoriatic arthritis (in adults)
• moderate to severe Crohn’s disease in adults and children weighing at least 40 kg

Plaque psoriasis
Plaque psoriasis is a skin condition causing inflammation of the skin and nails.
Uzpruvo will reduce 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 are ineffective.
Uzpruvo is used in children and adolescents 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 joint disease, usually associated with psoriasis. If you have active psoriatic arthritis, you will first be treated with other medicines. If you do not respond adequately to these medicines, you may be given 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 bowel disease. If you have Crohn’s disease, you will first be treated with other medicines. If you do not respond sufficiently or are intolerant to these medicines, Uzpruvo may be given to reduce the signs and symptoms of the disease.

2. What you should know before using Uzpruvo

Do not use Uzpruvo

• If you are allergic to ustekinumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an active infection that your doctor considers important.

If you are unsure whether any of the conditions above 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 inform your doctor, before each treatment, about any medical conditions you have. Also, tell your doctor if you have recently been in contact with people who might have had tuberculosis. Your doctor will examine you and perform tests for tuberculosis before administering Uzpruvo. If your doctor believes you are at risk of tuberculosis, you may be given medicines to treat tuberculosis.

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.

Before using Uzpruvo, contact your doctor

• If you previously had an allergic reaction to Uzpruvo. Ask your doctor if you are unsure.

• If you previously 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 biological 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 recently had an infection.

• If you have developed any new or changed skin lesions within the area of psoriasis or on normal skin.

• If you are currently receiving any other 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 may also partially reduce immune system activity. The combined use of these therapies with Uzpruvo has not been studied. However, it could increase the likelihood of conditions related to a weakened immune system.

• If you are currently using or have previously used allergy injections – it is not known whether Uzpruvo may affect them.

• If you are aged 65 years or older – you may have a higher risk of developing infections.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before starting treatment with Uzpruvo.
During treatment with ustekinumab, some patients have developed lupus-like reactions, including cutaneous lupus or lupus-like syndrome (lupus-like syndrome). Contact your doctor immediately if you develop a red, raised, scaly rash, sometimes with a darker border, on areas of skin exposed to sunlight, or if you experience joint pain.

Heart attack and stroke
In a study of patients with psoriasis treated with ustekinumab, heart attacks and strokes were observed. Your doctor will regularly monitor risk factors for heart disease and stroke to ensure they are appropriately managed. Seek immediate medical attention if you develop chest pain, weakness or a strange sensation on one side of the body, facial drooping, or speech or vision problems.

Children and adolescents
Uzpruvo is not recommended for the treatment of children and adolescents under 6 years of age with psoriasis, children with Crohn’s disease weighing less than 40 kg, or children under 18 years of age with psoriatic arthritis, as it has not been studied in these age groups.

Other medicines, vaccines, and Uzpruvo
Inform 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 scheduled 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 paediatrician about the Uzpruvo treatment before your child receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). If you received Uzpruvo during pregnancy, live vaccines are not recommended for your child during the first twelve months after birth, unless otherwise recommended by your child’s paediatrician.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.

• In newborns exposed to ustekinumab in the womb, no increased risk of congenital malformations has been observed. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.

• If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant; you should use an adequate method of contraception during treatment with Uzpruvo and for at least 15 weeks after stopping treatment with Uzpruvo.

• Ustekinumab can pass to the unborn child through the placenta. If you received Uzpruvo during pregnancy, your baby may have an increased risk of developing an infection.

• If you received Uzpruvo during pregnancy, it is important to inform your baby’s paediatrician and other healthcare providers before your baby receives any vaccine. If you received Uzpruvo during pregnancy, live vaccines such as the BCG vaccine (used to prevent tuberculosis) are not recommended for your baby during the first twelve months after birth, unless otherwise recommended by the paediatrician.

• Ustekinumab may be excreted in breast milk in very small amounts. If you are breastfeeding or planning to breastfeed, consult your doctor. You and your doctor will decide whether you should breastfeed or use Uzpruvo. You cannot do both.

Driving and using machines
Ustekinumab does not affect or has negligible influence on the ability to drive vehicles or operate machinery.

Uzpruvo contains polysorbate 80
This medicine contains 0.04 mg of polysorbate 80 per mL. Polysorbates may cause allergic reactions. Inform 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.
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor. Discuss with your doctor when you should receive injections and follow-up visits.
How much Uzpruvo is administered
Your doctor will decide how much Uzpruvo you need and for how long.
Adults from 18 years of age
Psoriasis and psoriatic arthritis

• The recommended initial dose is 45 mg of Uzpruvo. Patients weighing more than 100 kilograms (kg) may start with a dose of 90 mg instead of 45 mg.
• Four weeks after the initial dose, you will receive the next dose, followed by doses 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 is administered by your doctor via an intravenous infusion (IV infusion) into your arm. After the initial dose, you will receive the next dose of 90 mg of Uzpruvo after 8 weeks, then every 12 weeks via 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. Your doctor will decide when the next dose should be given.

Children and adolescents from 6 years of age
Psoriasis

• Your doctor will calculate the correct dose, including the amount (volume) of Uzpruvo to be injected to ensure the correct dose is administered. The correct dose will depend on the child's body weight at the time of each dose administration.
• For children and adolescents requiring a dose lower than 45 mg, a 45 mg vial is available.
• If body weight is below 60 kg, the recommended dose is 0.75 mg of Uzpruvo per kg of body weight.
• If body weight is between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo.
• If body weight exceeds 100 kg, the recommended dose is 90 mg of Uzpruvo.
• Four weeks after the initial dose, you will receive the next dose, followed by doses every 12 weeks.

Children weighing at least 40 kg
Crohn’s disease

• During treatment, the first dose of approximately 6 mg/kg of Uzpruvo is administered by your doctor via an intravenous infusion into the arm (intravenous infusion). Eight weeks after the initial dose, you will receive the next dose of 90 mg of Uzpruvo, followed by doses every 12 weeks via 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. Your doctor will decide when the next dose should be administered.

How Uzpruvo is administered

• Uzpruvo is administered via a subcutaneous injection (“subcutaneous route”). At the beginning of treatment, medical or nursing staff may administer Uzpruvo to you.
• However, you and your doctor may decide whether you can self-inject Uzpruvo. In this case, you will be trained on how to self-inject Uzpruvo.
• For instructions on how to inject Uzpruvo, see “Instructions for administration” at the end of this leaflet. Inform your doctor if you have any questions about self-injection.

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 miss 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
Stopping treatment with Uzpruvo is not dangerous. However, if you stop treatment, disease symptoms
may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 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, or low blood pressure, which may cause dizziness or lightheadedness, or 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. 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 Uzpruvo again.
Infections – these may require urgent treatment, so contact your doctor immediately if you notice any of the following signs.

• Nasal, 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 beneath 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 reduce 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 primarily occur 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 aware of the signs of infection while using Uzpruvo. 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 sensation when urinating
• diarrhoea
• visual disturbance or loss of vision
• headache, neck stiffness, 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, which can have serious complications. Consult your doctor if you have any infection that persists or keeps recurring. Your doctor may decide to stop Uzpruvo until the infection resolves. Also inform 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, inform your doctor immediately.
Other side effects
Common side effects (may affect up to 1 in 10 people)

• Diarrhoea
• 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 new small yellow or white blisters, 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 may 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)

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 30 minutes).
• If necessary, individual pre-filled syringes of Uzpruvo may also be stored at room temperature up to 30°C for a single period of up to 30 days, kept in the outer packaging to protect from light. Once removed from the refrigerator for the first time, record the date of disposal in the designated space on the outer packaging. The disposal 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 comes first.
• 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 carton following EXP or Scad. The expiry date refers to the last day of that month.
• If the solution changes colour, becomes cloudy, or contains foreign floating particles (see section 6 “Description of the appearance of Uzpruvo and contents of the pack”).
• If you know or suspect the medicine has been exposed to extreme temperatures (e.g. accidentally frozen or overheated).
• If the product has been shaken vigorously.

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

6. Package contents and other information

What Uzpruvo contains

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 mL.
• The other components 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, colourless to slightly yellow injectable solution, practically free from visible particles. It is supplied in a cardboard pack containing 1 or 2 single doses in 1 mL glass pre-filled syringes. Each pre-filled syringe contains a single dose of 90 mg ustekinumab 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
EG (Eurogenerics) NV UAB „STADA Baltics“
Tél/Tel: +32 24797878 Tel: +370 52603926

България Luxembourg/Luxemburg
STADA Bulgaria EOOD EG (Eurogenerics) NV
Teл.: +359 29624626 Tél/Tel: +32 24797878

Česká republika Magyarország
STADA PHARMA CZ s.r.o. STADA Hungary Kft
Tel: +420 257888111 Tel.: +36 18009747

Danmark Malta
STADA Nordic ApS Pharma.MT Ltd
Tlf: +45 44859999 Tel: +356 21337008

Deutschland Nederland
STADAPHARM GmbH Centrafarm B.V.
Tel: +49 61016030 Tel.: +31 765081000

Eesti Norge
UAB „STADA Baltics“ STADA Nordic ApS
Tel: +372 53072153 Tlf: +45 44859999

Ελλάδα Österreich
DEMO S.A. Pharmaceutical Industry STADA Arzneimittel GmbH
Τηλ: +30 2108161802 Tel: +43 136785850

España Polska
Laboratorio STADA, S.L. STADA Pharm Sp. z o.o.
Tel: +34 934738889 Tel: +48 227377920

France Portugal
EG LABO - Laboratoires EuroGenerics Stada, Lda.
Tél: +33 146948686 Tel: +351 211209870

Hrvatska România
STADA d.o.o. STADA M&D SRL
Tel: +385 13764111 Tel: +40 213160640

Ireland Slovenija
Clonmel Healthcare Ltd. Stada d.o.o.
Tel: +353 526177777 Tel: +386 15896710

Ísland Slovenská republika
STADA Arzneimittel AG STADA PHARMA Slovakia, s.r.o.
Sími: +49 61016030 Tel: +421 252621933

Italia Suomi/Finland
EG SpA STADA Nordic ApS, Suomen sivuliike
Tel: +39 028310371 Puh/Tel: +358 207416888

Κύπρος Sverige
DEMO S.A. Pharmaceutical Industry STADA Nordic ApS
Τηλ: +30 2108161802 Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +371 28016404

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 on 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 or healthcare professional will assist you with the first injection. However, you and your doctor may decide that you can self-inject Uzpruvo. In this case, you will be trained on how to self-administer Uzpruvo. Inform your doctor if you have any questions about self-injection.

Important information:

• For subcutaneous use only
• Do not mix Uzpruvo with other injectable liquids
• Do not shake the pre-filled syringes of Uzpruvo, as shaking may damage the medicine. Do not use the medicine if it has been shaken vigorously. Use a new pre-filled syringe instead.

Check the pre-filled syringe to ensure that:

• the number of pre-filled syringes and the dose are correct; if your dose is 90 mg, you will use 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, colourless to pale yellow, and practically free from visible particles
• the solution in the pre-filled syringe has not been frozen
• the solution has reached room temperature (approximately 30 minutes)

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

Plunger Stopper Body of syringe Needle Needle cap
Figure 1

1. Prepare the materials:

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

• Antiseptic wipes
• Cotton balls or gauze pads
• Adhesive bandage
• The prescribed dose of Uzpruvo (see Figure 1)
• A puncture-resistant sharps disposal container (not included). See Figure 2

Collect all supplies and place them on a clean surface.

Uzpruvo
Pre-filled syringe
Antiseptic wipes
Sharps disposal container
Adhesive bandage
Cotton ball or gauze
Figure 2

2. Choosing and preparing the injection site:

Choose an injection site (see Figure 3)

• Uzpruvo is administered by injection under the skin (subcutaneous injection).
• Choose an injection site. Suitable areas for injection are the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
• If someone is assisting you with the injection, you may also choose the upper arms or buttocks (see Figure 3).
• Use a different injection site for each injection. Do not inject into areas of skin that are tender, bruised, red, or hard.

The yellow areas indicate recommended injection sites.
Figure 3
Preparing the injection site

• Wash your hands thoroughly with soap and warm water.
• Clean the skin where you plan to give the injection with an antiseptic swab.
• Do not touch this area again before administering the injection. Allow the skin to dry before injecting.
• Do not fan or blow air onto the cleaned area.
• Do not inject through clothing.

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

• When ready to inject Uzpruvo, remove the needle cap
• Do not touch the plunger while removing the needle cap
• Hold the pre-filled syringe body with one hand and pull off the needle cap (see Figure 4)
• Dispose of the needle cap in the trash. Do not re-cap it
• You may 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:

Hold the syringe:

• Hold the pre-filled syringe body in one hand between your thumb and index finger (see Figure 5)
• Do not use the pre-filled syringe if it does not have the needle protective cap. If this is the case, contact your doctor or pharmacist for instructions
• Never pull back the plunger

Figure 5
Pinch the skin and insert the needle:

• Use the other hand to gently lift and firmly hold the cleaned area of skin
• With a quick, dart-like motion, insert the needle into the skin at an angle of approximately 45 degrees, while keeping the skin pinched (see Figure 6)

Figure 6
Inject the medicine:

• Inject all the liquid by using your thumb to push the plunger all the way down until the pre-filled syringe is empty (see Figure 7)

Figure 7
Allow the needle to retract:

• When the plunger is fully depressed, 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, retracting the needle into the needle shield (see Figure 8)

Figure 8

5. After the injection:

• After completing the injection, place a cotton ball or gauze pad over the injection site for a few seconds (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 may cover the injection site with a small plaster, if needed.

Figure 9
6 Disposal:

• Immediately after use, place used syringes in a puncture-resistant container, such as a sharps container, according to local regulations. Do not dispose of (throw away) syringes in household waste (see Figure 10).
• 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 the safety and health of others.

Figure 10