Pyzchiva 45 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pyzchiva 45 mg solution for injection in a pre-filled pen

ustekinumab

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end includes information on how to report these adverse reactions.

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

This leaflet has been written for the person using the medicine.

• 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; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse reactions
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 identify 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 administered with the pre-filled pen is used to treat the following inflammatory conditions:

• Plaque psoriasis – in adults
• 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. Pyzchiva reduces inflammation and other signs of the disease.

Pyzchiva administered with the pre-filled pen is used in adults with moderate to severe plaque psoriasis who cannot use ciclosporin, methotrexate, or phototherapy, or when these treatments are not effective.

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 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 medicines. If you do not respond adequately or cannot tolerate these medicines, 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 ingredients 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 to use Pyzchiva. 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 use 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 pay attention to certain signs of illness while using Pyzchiva. See the complete list of these adverse effects in the section “Serious adverse effects” under section 4.

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 – this is because immunosuppressants like ustekinumab weaken part of the immune system. This may increase the risk of developing cancer.
• If you have previously been treated 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 within the psoriasis-affected area or on intact skin.
• If you are receiving any other treatment for psoriasis and/or psoriatic arthritis – such as other immunosuppressants or phototherapy (where 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, they may increase the likelihood of developing illnesses associated with 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, in areas of skin exposed to sunlight, or if 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 the pre-filled pen formulation of ustekinumab is not recommended in children and adolescents under 18 years of age with psoriasis or Crohn’s disease, as it has not been studied in this age group. For children aged 6 years and older and adolescents with psoriasis, the pre-filled syringe or vial should be used instead. For children weighing at least 40 kg with Crohn’s disease, the infusion solution, vial, or pre-filled syringe should be used.

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

Use of Pyzchiva with other medicines, 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 Pyzchiva treatment before your infant receives any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis). Live vaccines for your infant are not recommended 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 may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• No increased risk of congenital malformations has been observed in babies exposed to ustekinumab in utero. However, experience with ustekinumab in pregnant women is limited. Therefore, it is preferable to avoid using ustekinumab during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use effective contraception while receiving ustekinumab and for at least 15 weeks after the last dose.
• 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 if you received Pyzchiva during your 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 simultaneously.

Driving and using machines

The effect of ustekinumab on the ability to drive and operate machinery is negligible or none.

Pyzchiva contains polysorbate 80 (E433)

This medicine contains 0.02 mg of polysorbate 80 (E433) per pre-filled pen (1 ml), equivalent to 0.02 mg/0.5 ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Pyzchiva

Pyzchiva should 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 as given 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 Pyzchiva is administered

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

Adults from 18 years of age

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 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 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, by 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 (“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 will self-inject Pyzchiva. In that case, you will be trained on how to inject Pyzchiva yourself.

• 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 self-injection.

If you use more Pyzchiva than you should

If you have used or have been given too much Pyzchiva, speak immediately with your doctor or pharmacist. Always keep 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 using Pyzchiva

Stopping ustekinumab is not dangerous. However, if you stop, 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 (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 have a severe allergic reaction, your doctor may decide that you should not use Pyzchiva again.

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 having difficulty breathing; persistent cough,
• skin feeling hot, red and painful, or a painful blistering skin rash,
• burning sensation when urinating,
• diarrhoea,
• visual deterioration or loss of vision,
• 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):

• Diarrhoea
• 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 on the skin, 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, itchy and painful (bullous pemphigoid).
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash in sun-exposed areas of skin, 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 included 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 pre-filled pen in the outer packaging to protect it from light.
• If necessary, individual pre-filled pens of Pyzchiva may also be stored at room temperature up to 30 °C for a maximum period of up to 35 days, keeping them in their original carton to protect them from light. When removing the pre-filled pen from the refrigerator for the first time, write the date in the designated space on the outer packaging. At any time before the end of this period, the product may be returned to the refrigerator once and stored there until the original expiration date. Discard the pen if not used within the maximum 35-day period at room temperature or before the original expiration date, whichever occurs first.
• Do not shake the pre-filled pens of Pyzchiva. Prolonged vigorous shaking may damage the medicine.

Do not use this medicine:

• After the expiry date stated on the label and packaging following “CAD/EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains foreign particles floating in it (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 pre-filled pen must be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pyzchiva

• 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 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 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 and Manufacturer

Samsung Bioepis NL. B.V.

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Traceability:

In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product must be clearly recorded.

Date of the latest revision of this leaflet: MM/YYYY

Other sources of information

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

INSTRUCTIONS FOR USE

Pyzchiva

(ustekinumab)

injection, for subcutaneous use

Prefilled pen

Instructions for injecting Pyzchiva using a prefilled pen.

Read these instructions for use before starting to use Pyzchiva. Your healthcare professional must show you how to correctly prepare and administer your Pyzchiva injection.

If you cannot administer the injection yourself:

• ask your healthcare professional for help, or
• ask someone who has been trained by a healthcare professional to administer the injections to you.

Do not attempt to inject Pyzchiva yourself until your healthcare professional has shown you how to do so.

Do you need help?

Consult your doctor for any questions you may have. For further assistance or to share your experience, refer to the contact information of your local representative provided in the package leaflet.

Important information you should know before injecting Pyzchiva

• For subcutaneous injection only (inject directly under the skin)
• Do not remove the needle cap before you are ready to inject.
• Do not shake the prefilled pen at any time. Shaking the prefilled pen may damage the Pyzchiva medicine.

Storage of the Pyzchiva prefilled pen:

• Store Pyzchiva in the refrigerator (between 2 °C and 8 °C).
• Store Pyzchiva in its original carton to protect it from light or physical damage.
• If necessary, individual Pyzchiva prefilled pens may also be stored at room temperature up to 30 °C for a maximum of 1 month, keeping them in their original carton to protect from light. Write the date when the prefilled pen is first removed from the refrigerator in the designated space on the outer packaging. At any time before the end of this period, the product may be returned to the refrigerator once and stored there until the original expiry date. Discard the pen if it is not used after the maximum 1-month period at room temperature or before the original expiry date, whichever comes first. Do not store Pyzchiva under extreme heat or cold conditions.
• Do not freeze.

Preparing the injection with the Pyzchiva prefilled pen

Step 1. Before starting, check the carton to ensure you have the correct dose. You will receive either 45 mg or 90 mg, as prescribed by your doctor.

• If your dose is 45 mg, you will receive one 45 mg prefilled pen.
• If your dose is 90 mg, you will receive either one 90 mg prefilled pen or two 45 mg prefilled pens. If you receive two 45 mg prefilled pens for a 90 mg dose, two injections must be administered, one after the other.

Step 2. Gather supplies

• Step 2.1: Choose a clean, flat, well-lit work surface.

• Step 2.2: Gather the supplies you will need to prepare and administer your injection (Figure B).
  You will need the following supplies:

  • Included in the carton:

• Pyzchiva prefilled pen

  • Not included in the carton:

• Alcohol wipe

• Cotton wool or gauze pads

• Adhesive bandage

• Sharps container (see "How to dispose of the Pyzchiva prefilled pen").

Step 3. Inspect the prefilled pen (Figure C)

• Step 3.1: Check the expiry date on the prefilled pen or carton.

• Step 3.2: Check for particles or color changes in the medicine through the viewing window. The medicine should appear clear and colorless to pale yellow, with some white particles.

• Step 3.3: Ensure the pen is not damaged.

• Do not use Pyzchiva if:

• the expiry date has passed, or if the prefilled pen has been stored at room temperature up to 30 °C for longer than 1 month, or if it has been stored above 30 °C;

• it is frozen, discolored, cloudy, or contains large particles;

• it is damaged;

• it has been dropped and is cracked or broken.

• It is normal to see 1 or more bubbles in the viewing window.

Step 4. Allow the medicine to reach room temperature

• For a more comfortable injection, allow the Pyzchiva prefilled pen to sit at room temperature for about 30 minutes before injecting, after removing it from the refrigerator.
• Do not heat the prefilled pen in any other way (for example, do not heat it in a microwave or in warm water).

Step 5. Wash your hands

• Wash your hands thoroughly with warm water and soap (Figure D).

Step 6. Choose the injection site

• Choose an injection site on the thigh or lower abdomen (lower part of the abdomen), at least 5 cm away from the navel. If a caregiver is administering the injection, it may also be given on the outer area of the upper arm (Figure E).
• Use a different injection site for each injection.
• Do not administer the injection into an area of skin that is tender, bruised, red, hard, or shows signs of psoriasis.

Step 7. Clean the skin at the injection site

• Clean the skin with a new alcohol wipe at the site where you will administer the injection (Figure F).
• Do not touch this area again before administering the injection. Allow the skin to dry before injecting.
• Do not fan or blow on the cleaned area.

Injecting with the Pyzchiva prefilled pen

Step 8. Remove the needle cap when ready to inject Pyzchiva (Figure G).

• Discard the needle cap.
• It is normal for a few drops of liquid to appear at the needle.
• Do not twist or bend the needle cap when removing it, as this may damage the needle.
• Do not use the prefilled pen if it has been dropped after removing the needle cap. Contact your healthcare professional for instructions.

Step 9. Place the prefilled pen directly on the skin at a 90-degree angle (Figure H).

Step 10. Press the prefilled pen firmly against the skin to start the injection (Figure I).

• You may hear a first click when the injection begins.

Step 11. Continue pressing against the skin until the yellow indicator stops moving (Figure J).

The injection may take up to 10 seconds.

• You may hear a second click. This indicates that the injection is complete.
• Do not stop applying pressure at the injection site until the injection is finished.
• Do not move the prefilled pen during the injection.

Step 12. Check that the viewing window has turned yellow to ensure the full dose has been administered, then remove the empty pen from the skin (Figure K).

• The needle shield will fully cover the needle.
• As shown in Figure K, a small grey band may still be visible in the viewing window.
• After removing the needle from the skin, slight bleeding or a few drops at the injection site may occur. This is normal. If needed, you may press the injection site with a cotton ball or gauze. Do not rub the skin at the injection site. If necessary, you may cover the injection site with a small adhesive bandage.

If your dose is 90 mg, you will receive either one 90 mg prefilled pen or two 45 mg prefilled pens. If you receive two 45 mg prefilled pens for a 90 mg dose, a second injection must be administered immediately after the first. Repeat steps 1–12 for the second injection using a new pen. Choose a different injection site for the second injection.

How to dispose of the Pyzchiva prefilled pen

Step 13. Immediately after use, place the used pen into a sharps container (Figure L).

• Do not throw (discard) loose pens into the trash.
• Do not recycle used sharps containers.

Keep Pyzchiva and all medicines out of the reach of children.