Pyzchiva 90 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pyzchiva 90 mg solution for injection in 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 the entire leaflet carefully before you start using this medicine, because 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 Pyzchiva to a child, please read this information carefully.

• Keep this leaflet, as 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 and must not be given to other people, 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 side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Pyzchiva is and what it is used for

What Pyzchiva is

Pyzchiva contains the active substance “ustekinumab”, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognize and bind to certain proteins in the body.

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

What Pyzchiva is used for

Pyzchiva is used to treat the following inflammatory diseases:

• Plaque psoriasis – in adults and children 6 years of age 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 that causes inflammation affecting the skin and nails. Pyzchiva reduces inflammation and other signs of the disease.

Pyzchiva is used in adults with moderate to severe plaque psoriasis who cannot use cyclosporine, methotrexate, or phototherapy, or when these treatments are ineffective.

Pyzchiva is used in children and adolescents 6 years of age 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 medications. If you do not respond well to these medications, you may be treated with Pyzchiva 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 medications. If you do not respond adequately or cannot tolerate those medications, you may be given Pyzchiva to reduce the signs and symptoms of your disease.

2. What you need to know before using Pyzchiva

Do not use Pyzchiva

• 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 significant.

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before using Pyzchiva.

Warnings and precautions

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

Be aware of serious adverse effects

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

Before using Pyzchiva, tell your doctor:

• If you have ever had an allergic reaction to ustekinumab. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like ustekinumab weaken part of the immune system, which may increase the risk of developing cancer.
• If you have been treated for psoriasis with other biologics (a medicine derived from a biological source, usually administered by injection) – the risk of developing cancer may be higher.
• If you have any new skin lesions or changes in existing lesions within the psoriasis area or on intact skin.
• If you currently have or have recently had an infection.
• If you are taking any other treatments 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 ustekinumab has not been studied. However, combining them may 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 ustekinumab 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 Pyzchiva.

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, on sun-exposed skin areas, or if it is accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of patients with psoriasis 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 ustekinumab 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 Pyzchiva with other medicines and vaccines

Inform your doctor or pharmacist:

• If you are currently using, have recently used, or might use any other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) should not be administered while you are receiving Pyzchiva.
• If you received Pyzchiva during pregnancy, inform your infant’s doctor about your treatment with Pyzchiva 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 Pyzchiva during pregnancy, unless otherwise advised by your infant’s doctor.

Pregnancy and breastfeeding

• If you are pregnant, think you might 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 ustekinumab during pregnancy.
• Women of childbearing potential are advised to avoid becoming pregnant and to use effective contraception while receiving ustekinumab and for at least 15 weeks after the last dose.
• Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant.
• Pyzchiva can cross the placenta to the fetus. If you received Pyzchiva during pregnancy, your infant may have an increased risk of developing infections.
• It is important to inform your infant’s doctors and other healthcare professionals that you received Pyzchiva during pregnancy before your 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 Pyzchiva 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 ustekinumab. Do not do both at the same time.

Driving and using machines

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

Pyzchiva contains polysorbate 80 (E433)

This medicine contains 0.04 mg of polysorbate 80 (E433) per pre-filled syringe (1 ml), equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Pyzchiva

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

Always follow exactly the instructions for administration of this medicine provided by your doctor. If you are unsure, ask your doctor. Ask your doctor when your injections should be given and about follow-up appointments.

What dose of Pyzchiva is administered

Your doctor will decide the dose of Pyzchiva you need and the duration of treatment.

Adults aged 18 years and older

Psoriasis or psoriatic arthritis

• The recommended starting dose is 45 mg of Pyzchiva. 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 then every 12 weeks. Subsequent 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 Pyzchiva as an intravenous infusion (a drip into a vein in your arm). After the initial dose, you will receive the next dose of 90 mg of Pyzchiva 8 weeks later, and then every 12 weeks, as an injection under the skin (“subcutaneously”).
• In some patients, after the first subcutaneous injection, 90 mg of Pyzchiva 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 Pyzchiva 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.
• A 45 mg vial is available for children who require a lower dose than the full 45 mg dose.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Pyzchiva per kg of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of Pyzchiva.
• If you weigh more than 100 kg, the recommended dose is 90 mg of Pyzchiva.
• After the initial dose, you will receive the next dose 4 weeks later, and then 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 Pyzchiva as an intravenous infusion (a drip into a vein in your arm). After the initial dose, you will receive the next dose of 90 mg of Pyzchiva 8 weeks later, and then every 12 weeks, as an injection under the skin (“subcutaneously”).
• In some patients, after the first subcutaneous injection, 90 mg of Pyzchiva will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How Pyzchiva is administered

• Pyzchiva is administered by subcutaneous injection (injection under the skin). At the beginning of your treatment, medical or nursing staff may administer Pyzchiva to you.

• However, you and your doctor may decide that you can self-inject Pyzchiva. In this case, you will be trained on how to self-inject Pyzchiva.

• For instructions on how to inject Pyzchiva, 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 Pyzchiva than you should

If you have used or been given too much Pyzchiva, speak immediately with your doctor or pharmacist. Always carry the medicine carton with you, even if it is empty.

If you forget to use Pyzchiva

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 treatment with Pyzchiva

Stopping ustekinumab 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 will experience 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 (may affect up to 1 in 100 people).

In rare cases, lung-related allergic reactions 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 have a severe allergic reaction, your doctor may decide that you should no longer use Pyzchiva.

Infections – these may require urgent treatment. Contact your doctor immediately if you notice any of these signs.

• Nasal or 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 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).

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

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

• fever, flu-like symptoms, night sweats, weight loss,
• feeling tired or short of breath; persistent cough,
• skin that feels hot, red, and painful, or 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 infections such as chest infections, skin infections, herpes, or opportunistic infections, which could lead to serious 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 ustekinumab 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 peeling of the skin 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 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 in areas of skin exposed to sunlight, possibly accompanied by joint pains)

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 listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pyzchiva

• 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 prefilled syringe in the outer packaging to protect it from light.
• If necessary, individual prefilled syringes of Pyzchiva may also be stored at room temperature up to 30 °C for a single period of up to 35 days in their original carton to protect them from light. Write the date the prefilled syringe is first removed from the refrigerator in the designated space on the outer packaging. At any time before the end of this period, the syringe may be returned to the refrigerator once and stored there until the original expiration date. Discard the syringe if not used within the maximum 35-day period at room temperature or after the original expiration date, whichever occurs first.
• Do not shake the prefilled syringes of Pyzchiva. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging after “CAD/EXP”. The expiry date refers to the last day of the month indicated.
• If the solution changes colour, becomes cloudy, or contains foreign particles (see section 6, “Appearance of Pyzchiva 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.

Pyzchiva is for single use only. Any unused product remaining in the syringe must be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pyzchiva

• The active substance is ustekinumab. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml.
• The other components are histidine, histidine hydrochloride monohydrate, polysorbate 80 (E 433), sucrose, water for injections.

Appearance of Pyzchiva and contents of the pack

Pyzchiva is a clear, colourless to pale yellow injectable solution. The solution may contain a few translucent or white protein particles. It is supplied in a pack containing 1 pre-filled glass syringe of 1 ml. Each pre-filled syringe contains 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorisation Holder and Manufacturer

Samsung Bioepis NL B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Sandoz nv/sa Tel/Tel: +32 2 722 97 97	Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037
	Luxembourg/Luxembourg Sandoz nv/sa Tel.: +32 2 722 97 97
Czech Republic Sandoz s.r.o. Tel: +420 225 775 111	Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890
Denmark/Norway/Iceland/Sweden Sandoz A/S Tlf: +45 63 95 10 00	Malta Sandoz Pharmaceuticals d.d. Tel: +356 9964 4126
Germany Hexal AG Tel: +49 8024 908 0	Netherlands Sandoz B.V. Tel: +31 36 52 41 600
Estonia Sandoz d.d. Estonian branch Tel: +372 665 2400	Austria Sandoz GmbH Tel: +43 5338 2000
Greece SANDOZ HELLAS MONOPROSOPIKI EPE Tel: +30 216 600 5000	Poland Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 00
Spain Sandoz Farmacéutica, S.A. Tel: +34 900 456 856	Portugal Sandoz Farmacêutica Lda. Tel: +351 21 000 86 00
France Sandoz SAS Tel: +33 1 49 64 48 00	Romania Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 60
Croatia Sandoz d.o.o. Tel: +385 1 23 53 111	Slovenia Sandoz Pharmaceutical Company d.d. Tel: +386 1 580 29 02
Ireland Rowex Ltd. Tel: +353 27 50077	Slovakia Sandoz d.d. - organizational unit Tel: +421 2 48 200 600
Italy Sandoz S.p.A. Tel: +39 02 81280696	Finland/Finland Sandoz A/S Puh/Tel: +358 10 6133 400
Cyprus SANDOZ HELLAS MONOPROSOPIKI EPE Tel: +30 216 600 5000
Latvia Sandoz d.d. Latvia branch Tel: +371 67 892 006

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.

Date of the most recent review of this package leaflet: MM/YYYY

Other sources of information

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

Instructions for administration

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

• Do not mix Pyzchiva with other injectable liquids.
• Do not shake the prefilled syringes. The medicine may deteriorate if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

Figure 1 shows what the prefilled syringe looks like.

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

Preparation for using the prefilled syringe

• Remove the prefilled syringe(s) from the refrigerator. Leave the prefilled syringe outside the carton for 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature). Do not heat the prefilled syringe in any other way (for example, do not heat it in a microwave or in hot water). Do not remove the needle cap while waiting for the syringe to reach room temperature.
• Hold the prefilled syringe by the barrel with the shielded needle pointing upwards.
• Do not hold the syringe by the plunger head, plunger, needle shield wings, or needle cap.
• Do not pull out the plunger at any time.
• Do not remove the needle cap from the prefilled syringe until instructed to do so.

Check the prefilled syringe(s) to ensure that

• The number of prefilled syringes and the concentration are correct
  • If your dose is 90 mg, you will have one 90 mg prefilled syringe of Pyzchiva.
• It is the correct medicine.
• The expiry date has not passed.
• The prefilled syringe is not damaged.
• The solution in the prefilled syringe is clear and colourless to slightly yellow.
• The solution in the prefilled syringe does not have an abnormal colour, is not cloudy, and does not contain foreign particles.
• The solution in the prefilled syringe is not frozen.

Prepare all the materials you need and place them on a clean surface. Include antiseptic wipes, cotton wool or gauze, and a sharps container.

1. Choose and prepare the injection site:

Choose the injection site (see Figure 2).

• Pyzchiva is administered by injection under the skin (subcutaneously).
• Suitable injection sites include the upper thigh or the abdominal area (abdomen), at least 5 cm from the navel.
• As far as possible, avoid areas of skin showing signs of psoriasis.
• If someone else is administering the injection, they may also choose the upper arm as the injection site.

Prepare the injection site

• Wash your hands thoroughly with soap and lukewarm water.
• Clean the skin at the injection site with an antiseptic wipe.
• Do not touch this area again before administering the injection.
• Do not fan or blow on the cleaned area.

1. Remove the needle cap (see Figure 3):
   • The needle cap must not be removed until you are ready to inject.
   • Hold the prefilled syringe and grasp the barrel of the syringe with one hand.
   • Remove the needle cap and dispose of it. Do not touch the plunger while doing this.

• You may observe an air bubble in the prefilled syringe or a drop of liquid at the end of the needle. Both are normal and do not need to be removed.
• Do not touch the needle or allow it to touch any surface.
• Do not use the prefilled syringe if it has been dropped without the needle cap. If this happens, inform your doctor or pharmacist.
• Inject the dose immediately after removing the needle cap.

1. Inject the dose:
   • Hold the prefilled syringe in one hand between the index and middle fingers, place your thumb on the plunger head, and with the other hand gently pinch a fold of cleaned skin with your thumb and index finger. Do not squeeze tightly.
   • Do not pull out the plunger at any time.
   • With one quick motion, insert the needle through the skin as far as it will go (see Figure 4).

• Inject the entire medicine by pushing the plunger until the plunger head is completely within the needle shield wings (see Figure 5).

• After pushing the plunger as far as it will go, maintain pressure on the plunger head, withdraw the needle, and release the skin (see Figure 6).

• Slowly remove your thumb from the plunger head so that the empty syringe advances until the needle is completely covered by the needle shield, as shown in Figure 7:

1. After the injection:

   • Press the injection site with an antiseptic wipe for a few seconds after the injection.
   • A small amount of blood or liquid may appear at the injection site. This is normal.
   • You may press cotton wool or gauze on the injection site and hold it for 10 seconds.
   • Do not rub the skin at the injection site. You may cover the injection site with a plaster if needed.

2. Disposal:

   • Used syringes must be placed in a puncture-resistant container, such as a sharps container (see Figure 8). For your safety and health, and for the safety of others, never reuse the syringe. Dispose of your sharps container according to local regulations.
   • Antiseptic wipes and other materials may be discarded in the trash.