UZPRUVO 90 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Uzpruvo 90 mg Solution for Injection in Pre-filled Syringe

Ustekinumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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 the person taking the medicine. If you are the parent or caregiver of a child who will be taking Uzpruvo, please read this information carefully.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Uzpruvo and what is it used for

Uzpruvo contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that identify and bind to specific 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 from 6 years of age
• Psoriatic arthritis - in adults
• Moderate to severe Crohn's disease - in adults

Plaque Psoriasis

Plaque psoriasis is a skin disease that causes inflammation affecting 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 ciclosporin, methotrexate, or phototherapy, or where these treatments do not work.

Uzpruvo is used in children and adolescents from 6 years of age with moderate to severe plaque psoriasis who are not able to tolerate phototherapy or other systemic therapies or where these treatments do not work.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints, which usually occurs with psoriasis. If you have active psoriatic arthritis, you will first receive 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 damage to your joints.

Crohn's Disease

Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, you may be given Uzpruvo to reduce the signs and symptoms of your disease.

2. What you need to know before you use Uzpruvo

Do not use Uzpruvo

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Uzpruvo. Your doctor will check how you are before each treatment. Make sure you tell your doctor about any illness you have before each treatment. Your doctor will also ask if you have recently been near someone who may have tuberculosis. Your doctor will examine you and do a test to check for tuberculosis before you use Uzpruvo. If your doctor thinks you are at risk of tuberculosis, they may give you medicines to treat it.

Watch for serious side effects

Uzpruvo may cause serious side effects, including allergic reactions and infections. You should be aware of certain signs of illness while you are using Uzpruvo. See the complete list of these side effects in “Serious side effects” in section 4.

Tell your doctor before using Uzpruvo

• If you have ever had an allergic reaction to Uzpruvo.Check with your doctor if you are not sure.
• If you have ever had any type of cancer– this is because immunosuppressants like Uzpruvo weaken part of the immune system. This may increase the risk of having cancer.
• If you have been treated for psoriasis with other biologics (a medicine made from a biological source and usually given by injection)– the risk of having cancer may be higher.
• If you have had a recent infection.
• If you have any new or changing lesionswithin the area of psoriasis or on intact skin.
• If you are taking any other treatment for psoriasis and/or psoriatic arthritis– such as any other immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet light (UV)). These treatments may also weaken part of the immune system. It has not been studied whether these treatments can be used together with Uzpruvo. However, it may increase the likelihood of suffering from diseases related to a weaker immune system.
• If you are receiving or have ever received allergy shots– it is not known if Uzpruvo can affect these treatments.
• If you are 65 years of age or older– you are more likely to get infections.

If you are not sure if any of these conditions apply to you, talk to 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. Talk to your doctor immediately if you experience a red, raised, and scaly skin rash, sometimes with a darker border, in areas of skin exposed to the sun or if accompanied by joint pain.

Heart attacks and strokes

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

Children and adolescents

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

Using Uzpruvo with other medicines, vaccines

Tell your doctor or pharmacist:

• If you are using, have recently used, or might use other medicines.
• If you have been vaccinated recently or are going to have a vaccination.Certain types of vaccines (live vaccines) should not be given while you are using Uzpruvo.
• If you received Uzpruvo during pregnancy, inform your baby's doctor about your treatment with Uzpruvo before your baby receives any vaccination, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).Live vaccines are not recommended for your baby in the first 12 months after birth if you received Uzpruvo during pregnancy, unless your baby's doctor recommends otherwise.

Pregnancy and breastfeeding

• If you are pregnant or think you may be pregnant, consult your doctor before using this medicine.
• No increased risk of birth defects has been seen in babies exposed to ustekinumab in the womb.However, there is limited experience with ustekinumab in pregnant women. Therefore, it is preferable to avoid using Uzpruvo during pregnancy.
• If you are a woman of childbearing age, you are advised to avoid becoming pregnant and to use adequate contraceptive measures while you are using Uzpruvo and for at least 15 weeks after the last treatment with Uzpruvo.
• Ustekinumab may pass through the placenta to the fetus.If you received Uzpruvo during pregnancy, your baby may have a higher risk of getting an infection.
• It is important that you inform your baby's doctors and other healthcare professionals if you received Uzpruvo during your pregnancy before your baby receives any vaccination.Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first 12 months after birth if you received Uzpruvo during pregnancy, unless your baby's doctor recommends otherwise.
• 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 you should breastfeed or use Uzpruvo. Do not do both.

Driving and using machines

Uzpruvo has no or negligible influence on the ability to drive and use machines.

Uzpruvo contains polysorbate 80

This medicine contains 0.04 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How to use Uzpruvo

Uzpruvo should be used under the guidance and supervision of a doctor with experience in the treatment of the conditions for which Uzpruvo is indicated.

Always follow exactly the instructions of your doctor. If you are not sure, ask your doctor. Ask your doctor when you should have the injections and about follow-up appointments.

How much Uzpruvo to use

Your doctor will decide how much Uzpruvo you need to use and how long your treatment will last.

Adults from 18 years of age

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 take the next dose 4 weeks later and then every 12 weeks.The following doses are usually the same as the initial dose.

Crohn's disease

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

Children and adolescents from 6 years of age

Psoriasis

• Your doctor will tell you the correct dose for you, including the amount (volume) of Uzpruvo to inject to give the correct dose.The correct dose for you will depend on your body weight at the time of each dose.
• If you weigh less than 60 kg, there is no suitable form of Uzpruvo for children under 60 kg body weight.
• 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 then every 12 weeks.

How Uzpruvo is given

• Uzpruvo is given as an injection under the skin (“subcutaneously”).At the start of your treatment, medical staff may give you the injection.
• However, you and your doctor may decide that you can inject Uzpruvo yourself.In this case, you will be trained on how to inject Uzpruvo yourself.
• For instructions on how to inject Uzpruvo, see “Administration instructions” at the end of this leaflet.

Talk to your doctor if you have any questions about how to inject yourself.

If you use more Uzpruvo than you should

If you have used or been given too much Uzpruvo, talk to your doctor or pharmacist immediately. Always carry the medicine box with you, even if it is empty.

If you forget to use Uzpruvo

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

If you stop using Uzpruvo

Stopping Uzpruvo is not dangerous. However, if you stop using it, your symptoms may come back.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Some patients may have severe adverse effects that may require urgent treatment.

Allergic Reactions – these may require urgent treatment. Contact your doctor or get emergency medical help immediately 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). The signs include:

• difficulty breathing and swallowing
• low blood pressure, which can cause dizziness or mild headaches
• swelling of the face, lips, mouth, or throat.

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

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

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

Uzpruvo may affect your ability to fight infections. Some of them could become serious and be caused by viruses, fungi, bacteria (including tuberculosis), or parasites, and include infections that occur mainly in people with a weakened immune system (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eyes have been reported in patients receiving treatment with ustekinumab.

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

• fever, flu-like symptoms, night sweats, weight loss

• feeling tired or having difficulty breathing; cough that does not go away
• having hot, red, and painful skin or having a painful skin rash with blisters
• burning when urinating
• diarrhea
• visual impairment or loss of vision
• headache, neck stiffness, photosensitivity, nausea, or confusion.

Communicate with your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as chest infections, skin infections, herpes, or opportunistic infections that could have serious complications. You should also inform your doctor if you have any type of infection that does not go away or comes back. Your doctor may decide that you should not use Uzpruvo until the infection goes away. Also, contact your doctor if you have any open cuts or ulcers that could become infected.

Skin Detachment – increased redness and skin detachment over a large area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.

Other Adverse Effects

Frequent Adverse Effects(may affect up to 1 in 10 people):

• Diarrhea
• Nausea
• Vomiting
• Feeling tired
• Feeling dizzy
• 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 skin 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 skin detachment over a large area of the body, which can 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 can cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very Rare Adverse Effects(may affect up to 1 in 10,000 people):

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is 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 contribute to providing 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 and 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect it from light.
• Before administration, the pre-filled syringe should be allowed to reach room temperature (about half an hour).
• If necessary, individual pre-filled syringes of Uzpruvo can also be stored at room temperature up to 30 °C for a maximum single period of up to 30 days in their original carton to protect them from light. Once removed from the refrigerator, write the discard date on the space provided on the outer packaging. The discard date should 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 should not be stored in the refrigerator again. Discard the syringe if it is not used within 30 days of storage at room temperature or from 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 carton after "EXP". The expiry date is the last day of the month indicated.
• If the liquid changes color, is cloudy, or has large particles floating in it (see section 6 "Appearance of Uzpruvo and package contents").
• If you know or believe that it has been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been vigorously shaken.

Uzpruvo is for single use. You should discard any unused product left in the syringe. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Uzpruvo

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other ingredients are histidine, histidine hydrochloride monohydrate, polysorbate 80 (E433), sucrose, and water for injections.

Appearance of Uzpruvo and pack contents

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

It is provided in a pack containing 1 or 2 pre-filled syringe(s) of 1 ml glass, each pre-filled syringe containing 90 mg of ustekinumab in 1 ml of injectable solution.

Only certain 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

You can obtain more information about this medicinal product by contacting the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet

Other sources of information

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

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

Include QR code

Administration instructions

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 start of treatment, your healthcare professional will help you with your first injection. However, you and your doctor may decide that you can inject Uzpruvo yourself. If so, they will teach you how to inject Uzpruvo. Talk to your doctor if you have any questions 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 90 mg, you will have one pre-filled syringe of 90 mg of Uzpruvo

• 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 colorless to slightly yellowish 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 (about half an hour).

Figure 1 shows the Uzpruvo pre-filled syringe

Figure 1

1. Prepare the materials

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

• Antiseptic wipes
• Cotton balls or swabs
• Adhesive plaster
• Your prescribed dose of Uzpruvo (see Figure 1)
• A puncture-resistant sharps 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 top of the thigh, buttocks, or the abdomen (at least 5 cm from the navel)
• If someone else is administering the injection, the top of the arm can also be used as an injection site (see Figure 3)
• Use a different injection site each time you inject. Do not inject into an area of skin that is sensitive, bruised, red, or hard

The recommended injection sites are shown in yellow

Figure 3

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 injecting
• Do not ventilate or blow on 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 with 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 end 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

Figure 4

1. Inject the dose:

Hold the syringe:

• Hold the body of the pre-filled syringe between your 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

Figure 5

Pinch the skin and insert the needle:

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

Figure 6

Inject the medicine:

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

Figure 7

Allow the needle to retract:

• When you have pushed the plunger as far as it will go, maintain pressure on the plunger head. Remove the needle and release the skin.
• Slowly remove your thumb from the plunger head. The plunger will move up with your finger and retract the needle into the needle protector (see Figure 8).

Figure 8

1. After the injection:

• After completing the injection, press a cotton ball or swab over the injection site for a few seconds after the injection (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 can cover the injection site with an adhesive plaster if necessary

Figure 9

1. Disposal:

• Place used syringes in a puncture-resistant sharps container, similar to a container for disposing of sharps, immediately after use, in accordance with local regulations. Do not dispose of loose syringes in household waste (see Figure 10)
• Dispose of antiseptic wipes, cotton balls or swabs, and packaging in the trash
• For your safety and health and the safety of others, never reuse the syringe

Figure 10