Uzpruvo 45 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

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

ustekinumab

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

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

This leaflet has been written for the person using the medicine. If you are a parent or caregiver administering Uzpruvo to a child, please read this information carefully.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not share it with others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. 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 specifically recognize and bind to certain proteins in the body.

Uzpruvo belongs to a group of medicines called “immunosuppressants”. These medicines work by weakening part of the immune system.

What Uzpruvo is used for

Uzpruvo is used to treat the following inflammatory diseases:

• Plaque psoriasis – in adults and children aged 6 years and older
• 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 disease causing inflammation that affects the skin and nails. Uzpruvo reduces 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 when these treatments are ineffective.

Uzpruvo is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies, or when these treatments are ineffective.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, which is usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If you do not respond well to these medicines, you may be treated with Uzpruvo to:

• Reduce the signs and symptoms of your disease.
• Improve your physical function.
• Reduce joint damage.

Crohn’s disease

Crohn’s disease is an inflammatory bowel disease. If you have Crohn’s disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate those medicines, you may be given Uzpruvo to reduce the signs and symptoms of your 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 components 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 above apply to you, speak with your doctor or pharmacist before using Uzpruvo.

Warnings and precautions

Talk to your doctor or pharmacist before starting Uzpruvo. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any illness you may have before each treatment. Your doctor will also ask whether you have recently been in contact with someone who might have tuberculosis. Your doctor will examine you and perform a test to detect tuberculosis before you start using Uzpruvo. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious adverse effects

Uzpruvo may cause serious adverse effects, including allergic reactions and infections. You should pay attention to certain signs of illness while using Uzpruvo. See the complete list of these adverse effects in the “Serious adverse effects” section under section 4.

Before using Uzpruvo, tell your doctor

• If you have ever had an allergic reaction to Uzpruvo. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Uzpruvo weaken part of the immune system. This may increase the risk of developing cancer.
• If you have previously received treatment for psoriasis with other biologics (a medicine produced from a biological source and usually administered by injection) – the risk of developing cancer may be higher.
• If you currently have or have recently had an infection.
• If you have any new skin lesions or changes in existing lesions, either within the psoriatic area or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis, such as other immunosuppressants or phototherapy (when your body is treated with a type of ultraviolet (UV) light). These treatments may also weaken part of the immune system. The use of these treatments together with Uzpruvo has not been studied. However, combining them could increase the likelihood of developing illnesses related to a weaker immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Uzpruvo may affect these treatments.
• If you are 65 years of age or older – you may be more likely to develop infections.

If you are unsure whether any of these conditions apply to you, speak with your doctor or pharmacist before using Uzpruvo.

Some patients have experienced lupus-like reactions during treatment with ustekinumab, including cutaneous lupus or 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, especially if accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of psoriasis patients treated with ustekinumab. Your doctor will periodically check your risk factors for heart disease and stroke to ensure they are properly managed. Seek immediate medical attention if you experience chest pain, weakness or numbness on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

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

Use of Uzpruvo with other medicines, vaccines

Inform your doctor or pharmacist:

• If you are currently using, have recently used, or may use any other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) must not be administered while using Uzpruvo.
• If you received Uzpruvo during pregnancy, inform your infant’s doctor about your Uzpruvo treatment before the infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines are not recommended for your infant during the first twelve months after birth if you received Uzpruvo during pregnancy, unless otherwise advised by your infant’s doctor.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been observed in babies exposed to ustekinumab in the womb. 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, you are advised to avoid becoming pregnant and to use adequate contraception while using Uzpruvo and for at least 15 weeks after the last dose.
• Ustekinumab can cross the placenta to the fetus. If you received Uzpruvo during pregnancy, your infant may have an increased risk of infection.
• It is important to inform your infant’s doctors and other healthcare professionals if you received Uzpruvo during pregnancy before the infant receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your infant during the first twelve months after birth if you received Uzpruvo during pregnancy, unless otherwise recommended by your infant’s doctor.
• Ustekinumab may be excreted in breast milk in very small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether to breastfeed or use Uzpruvo. Do not do both simultaneously.

Driving and using machines

The effect of Uzpruvo on the ability to drive and use machines is negligible or none.

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 any known allergies.

3. How to use Uzpruvo

Uzpruvo should be used under the guidance and supervision of a physician experienced in the treatment of conditions for which Uzpruvo is indicated.

Always follow exactly the administration instructions provided by your doctor. If in doubt, ask your doctor. Ask your doctor when your injections should be given and about follow-up appointments.

How much Uzpruvo should be administered

Your doctor will decide the amount of Uzpruvo you need to use and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

• The recommended starting 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.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks. The following doses are usually the same as the starting dose.

Crohn's disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of Uzpruvo as an intravenous infusion (a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Uzpruvo 8 weeks later, and then every 12 weeks, by injection under the skin ("subcutaneously").
• In some patients, after the first subcutaneous injection, 90 mg of Uzpruvo will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents aged 6 years and older

Psoriasis

• Your doctor will determine the correct dose for you, including the amount (volume) of Uzpruvo to inject to deliver the correct dose. The appropriate dose for you will depend on your body weight at the time each dose is given.
• If you weigh less than 60 kg, there is no Uzpruvo dosage form available for children weighing less than 60 kg.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Uzpruvo.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Uzpruvo.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks.

Children weighing at least 40 kg

Crohn's disease

• During treatment, your doctor will administer the first dose of approximately 6 mg/kg of Uzpruvo as an intravenous infusion (a drip into a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of Uzpruvo 8 weeks later, and then every 12 weeks, by injection under the skin ("subcutaneously").
• In some patients, after the first subcutaneous injection, 90 mg of Uzpruvo will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How Uzpruvo is administered

• Uzpruvo is administered by subcutaneous injection ("under the skin"). At the beginning of your treatment, medical or nursing staff may administer Uzpruvo to you.
• However, you and your doctor may decide that you can self-inject Uzpruvo. In that 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.

Consult your doctor if you have any questions about how to self-inject.

If you use more Uzpruvo than you should

If you have used or been given too much Uzpruvo, speak immediately with your doctor or pharmacist.

Always carry the medicine carton with you, even if it is empty.

If you forget to use Uzpruvo

If you miss a dose, speak with your doctor or pharmacist. Do not take a double dose to make up for missed doses.

If you stop using Uzpruvo

Stopping the use of Uzpruvo is not dangerous. However, if you discontinue treatment, your symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Some patients may experience serious adverse effects that may require urgent treatment.

Allergic reactions – these may require urgent treatment. Contact your doctor or seek immediate medical help if you notice any of the following signs.

• Severe allergic reactions ("anaphylaxis") are rare in the population using ustekinumab (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing and swallowing

• low blood pressure, which may cause dizziness or mild headaches

• swelling of the face, lips, mouth, or throat.

• Common signs of an allergic reaction include rash and hives (these may affect up to 1 in 100 people).

In rare cases, allergic reactions affecting the lungs and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you develop symptoms such as cough, difficulty breathing, 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. Contact your doctor immediately if you notice any of these signs.

• Infections of the nose or 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 tissues beneath the skin ("cellulitis") is uncommon (may affect up to 1 in 100 people).
• Herpes (a type of painful blistering rash) is uncommon (may affect up to 1 in 100 people).

Uzpruvo may affect your ability to fight infections. Some of these infections could become serious and may be caused by viruses, fungi, bacteria (including tuberculosis), or parasites. These include 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 receiving ustekinumab treatment.

You should monitor for signs of infection while using Uzpruvo. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or having difficulty breathing; persistent cough
• skin feeling warm, red, and painful, or having a painful blistering skin rash
• burning sensation when urinating
• diarrhea
• visual deterioration or vision loss
• headache, neck stiffness, light sensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe complications. You should also inform your doctor if you have any infection that does not go away or keeps recurring. Your doctor may decide that you should not use Uzpruvo until the infection resolves. Also contact your doctor if you have any open cuts or ulcers that could become infected.

Skin peeling – increased redness and widespread skin peeling may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you must inform your doctor immediately.

Other adverse effects

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

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Dizziness
• Headache
• Itching ("pruritus")
• Back, muscle, or joint pain
• Sore throat
• Redness and pain at the injection site
• Sinusitis

Uncommon adverse effects (may affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Nasal congestion or stuffiness
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and sinking of the muscles 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 (skin exfoliation)
• Acne

Rare adverse 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 cause itching or pain (exfoliative dermatitis). Similar symptoms may develop as a natural change in psoriasis symptoms (erythrodermic psoriasis)
• Inflammation of small blood vessels, which may cause a skin rash with small red or purple raised spots, fever, or joint pain (vasculitis)

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

• Blisters on the skin, which may be red and cause itching and pain (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash on sun-exposed skin areas, possibly accompanied by joint pain).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Uzpruvo

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C to 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect it from light.
• Before administration, allow the pre-filled syringe 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 in their original carton to protect them from light. Once removed from the refrigerator, write the date when the syringe must be discarded in the designated space on the outer packaging. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to a maximum of 30 °C), it must not be returned to the refrigerator. Discard the syringe if it is not used within 30 days of storage at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of Uzpruvo. Prolonged vigorous shaking may damage the product.

Do not use this medicine

• After the expiry date stated on the label and packaging after “EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains large floating particles (see section 6 “What Uzpruvo looks like and contents of the container”).
• If you know or suspect it has been exposed to extreme temperatures (such as accidental overheating or freezing).
• If the product has been shaken vigorously.

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

6. Contents of the pack and other information

Composition of Uzpruvo

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml.
• The other components are histidine, histidine monohydrochloride, polysorbate 80 (E433), sucrose, and water for injections.

Appearance of Uzpruvo and contents of the pack

Uzpruvo is a clear, colourless to slightly yellowish injectable solution, practically free from particles.

It is supplied in a pack containing 1 single-use 1 ml glass pre-filled syringe. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

Marketing Authorization 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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

You can access detailed and up-to-date information about this medicine, including a video on how to use the pre-filled syringe, by scanning with your mobile phone (smartphone) the QR code included below or on the outer packaging. You can also access this information at the following internet address: uzpruvopatients.com

Include QR code

Administration instructions

INSTRUCTIONS FOR USE

Uzpruvo 45 mg solution for injection in pre-filled syringe

ustekinumab

for subcutaneous use

Read these instructions carefully before using Uzpruvo solution for injection in pre-filled syringe.

At the beginning of treatment, a healthcare professional will assist you with your first injection. However, you and your doctor may decide that you can self-administer Uzpruvo. In such a case, you will be trained on how to inject Uzpruvo. Speak with your doctor if you have any doubts about administering the injections.

Important information:

• For subcutaneous injection only
• Do not mix Uzpruvo with other injectable liquids.
• Do not shake the pre-filled syringes of Uzpruvo. The medicine may deteriorate if shaken vigorously. Do not use the medicine if it has been shaken vigorously. Choose a new pre-filled syringe.

Check the pre-filled syringe(s) to ensure that:

• the number of pre-filled syringes and the concentration are correct

• If your dose is 45 mg, you will have one 45 mg pre-filled syringe of Uzpruvo

• If your dose is 90 mg, you will have two 45 mg pre-filled syringes of Uzpruvo and will need to administer two injections. Choose two different injection sites (e.g. one in the right thigh and one in the left thigh), and inject one immediately after the other

• it is the correct medicine

• the expiry date has not passed

• the pre-filled syringe is not damaged

• the solution in the pre-filled syringe is clear and colourless to slightly yellow and practically free from visible particles

• The solution in the pre-filled syringe is not frozen

• Before administration, allow the pre-filled syringe to reach room temperature (approximately 30 minutes).

Figure 1 shows what the Uzpruvo pre-filled syringe looks like

1. Prepare the materials

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

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

Prepare all the materials you need and place them on a clean surface.

1. Choose and prepare the injection site:

Choose the injection site (see Figure 3)

• Uzpruvo is administered by injection under the skin (subcutaneously)
• Choose an injection site. Suitable injection sites include the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel
• If someone else is administering the injection, the upper arm or buttocks may also be used as injection sites (see Figure 3)
• Use a different injection site for each injection. Do not administer an injection into an area of skin that is tender, bruised, red, or hard

Prepare the injection site

• Wash your hands thoroughly with soap and warm water
• Clean the skin at the injection site with an antiseptic wipe
• Do not touch this area again before administering the injection. Allow your skin to dry before the injection
• Do not blow or fan the cleaned area
• Do not inject through clothing

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

• Remove the needle cap when you are ready to inject Uzpruvo
• Do not touch the plunger while removing the needle cap
• Hold the body of the pre-filled syringe in one hand and remove the needle cap (see Figure 4)
• Discard the needle cap. Do not reuse it.
• You may see a drop of liquid at the tip of the needle. This is normal
• Do not touch the needle or allow it to touch any surface
• Inject the dose immediately after removing the needle cap

1. Inject the dose:

Hold the syringe:

• Hold the body of the pre-filled syringe in one hand between the thumb and index finger (see Figure 5)
• Do not use the pre-filled syringe if it has been dropped without the needle cap. If this happens, inform your doctor or pharmacist.
• Do not pull the plunger back at any time

Pinch the skin and insert the needle:

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

Inject the medicine:

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

Allow the needle to retract:

• After pushing the plunger as far as it will go, maintain pressure on the plunger head. Remove the needle and release the skin.
• Slowly release your thumb from the plunger head. The plunger will move upward with your finger and retract the needle into the needle shield (see Figure 8).

Figure 8

1. 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)
• There may be 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 an adhesive bandage if needed

1. Disposal:

• Immediately after use, place used syringes into a puncture-resistant container, such as a sharps disposal container, according to your local regulations. Do not throw (dispose of) loose syringes into household waste (see Figure 10)
• Dispose of antiseptic wipes, cotton balls or gauze, and packaging in the trash
• For your safety, your health, and the safety of others, never reuse the syringe