Pyzchiva 130 mg concentrado para solucion para perfusion

Patient Information Leaflet

Pyzchiva130mg Concentrate for Solution for Infusion

ustekinumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this 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.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What Pyzchiva is and what it is used for

2.What you need to know before you start using Pyzchiva

3.How to use Pyzchiva

4.Possible side effects

5.Storage of Pyzchiva

6.Contents of the pack and additional information

What is Pyzchiva

Pyzchiva contains the active ingredient “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 medications called “immunosuppressants”. These medications act by weakening part of the immune system.

What is Pyzchiva used for

Pyzchiva is used to treat the following inflammatory diseases:

• Moderate to severe Crohn's disease - in adults

Crohn's disease

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

No use Pyzchiva

• If you are allergic to ustekinumabor to any of the other ingredients of this medication (listed in section6).
• If you have an active infectionthat your doctor thinks is important.

If you are unsure if any of the above points concern you, speak with your doctor or pharmacist before using Pyzchiva.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Pyzchiva. Your doctor will check how you are before treatment. Make sure to inform your doctor about any illness you suffer from before treatment. Also inform your doctor if you have recently been near someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis detection before using Pyzchiva. If your doctor thinks you are at risk of tuberculosis, they may give you medication to treat it.

Observe severe adverse effects

Pyzchiva may cause severe adverse effects, including allergic reactions and infections. You must pay attention to certain signs of illness while using Pyzchiva. See the complete list of these adverse effects in “Severe adverse effects” of section4.

Tell your doctor before using Pyzchiva:

• If you have ever had an allergic reaction to ustekinumab.Consult with your doctor if you are unsure.
• If you have ever had any type of cancer– this is becauseimmunosuppressants like ustekinumab weaken part of the immune system. This may increase the risk of cancer.
• If you have received treatment for psoriasis with other biologics (a medication produced from a biological source and usually administered by injection)–the risk of developing cancer may be higher.
• If you have or have had a recent infection or have any skin cracks (fistula).
• If you have any new lesions or changes to existing lesionswithin the psoriasis disease area 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 (UV) light). These treatments may also weaken part of the immune system. Although these treatments have not been studied together with ustekinumab, it is possible that they may increase the likelihood of developing immune-related diseases.
• If you are receiving or have ever received injections to treat allergies– it is unknown if ustekinumab may affect these treatments.
• If you are 65years or older– you are more likely to acquire infections.

If you are unsure if you have any of these conditions, speak with your doctor or pharmacist before using Pyzchiva.

Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including lupus skin or lupus-like syndrome. Speak with your doctor immediately if you experience a red, raised, and scaly rash, sometimes with a darker border, on sun-exposed areas or accompanied by joint pain.

Heart attacks and strokes

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

Children and adolescents

Ustekinumab is not recommended for use in children under 18years of age with Crohn's disease, as it has not been studied in this age group.

Using Pyzchiva with other medications, vaccines

Inform your doctor or pharmacist:

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

Pregnancy and breastfeeding

• It is preferable to avoid using Pyzchiva during pregnancy. The effects of ustekinumab on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use suitable contraceptive measures while using ustekinumab and for at least 15weeks after the last treatment with ustekinumab.
• Inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant.
• Ustekinumab may pass through the placenta to the fetus. If you received Pyzchiva during pregnancy, your baby may have a higher risk of contracting an infection.
• It is essential to inform your baby's doctors and other healthcare professionals if you received Pyzchiva during pregnancy before your baby receives any vaccine. Live vaccines, such as the BCG vaccine (used to prevent tuberculosis), are not recommended for your baby in the first six months after birth if you received Pyzchiva 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 do so. You and your doctor will decide whether to breastfeed or use ustekinumab. Do not do both at the same time.

Driving and operating machinery

The influence of ustekinumab on the ability to drive and operate machinery is negligible or insignificant.

Pyzchiva contains sodium

Pyzchiva contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”. However, before Pyzchiva is administered to you, it is mixed with asolution that contains sodium.Consult with your doctor if you follow a low-sodium diet.

Pyzchiva contains polisorbate 80 (E433)

This medication contains 10.4 mg of polisorbate 80 (E433) in each vial (30 ml) equivalent to 10.4 mg/26 ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

Pyzchiva must be used under the guidance and supervision of a doctor with experience in the diagnosis and treatment of Crohn's disease.

Your doctor will administer Pyzchiva 130 mg concentrate for solution for infusion via a vein in the arm (intravenous infusion) for at least one hour.Pregunte a su médico cuándo deben ponerle las inyecciones y sobre las consultas de seguimiento.

What amount of Pyzchiva is administered

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

Adults 18 years of age and older

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

• After the initial intravenous dose, you will receive the next dose of 90 mg of Pyzchiva via a subcutaneous injection 8 weeks later, and then every 12 weeks thereafter.

How Pyzchiva is administered

The first dose of Pyzchiva for the treatment of Crohn's disease is administered by a doctor via infusion in a vein in the arm (intravenous infusion).

Consult with your doctor if you have any questions about treatment with Pyzchiva.

If you forget to use Pyzchiva

If you forget a dose or miss an appointment, speak with your doctor to schedule another appointment.

If you interrupt treatment with Pyzchiva

Stopping use of ustekinumab is not hazardous. However, if you stop, your symptoms may return.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Some patients may experience severe side 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 (they can affect up to 1 in 10,000 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 urticaria (these can affect up to 1 in 100 people).

Reactions related to infusion – If you are being treated for Crohn's disease, the first dose of ustekinumab is administered through a drip in a vein (intravenous infusion). Some patients have experienced severe allergic reactions during the infusion.

In rare cases, pulmonary allergic reactions 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 Pyzchiva again.

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

• Common colds and sore throats, and nasal infections are frequent (they can affect up to 1 in 10 people).
• Chest infections are rare (they can affect up to 1 in 100 people).
• Cellulitis, an inflammation of the tissues under the skin, is rare (it can affect up to 1 in 100 people).
• Herpes, a painful rash with blisters, is rare (it can affect up to 1 in 100 people).

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

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

• Fever, flu-like symptoms, night sweats, weight loss,
• Feeling tired or difficulty breathing; cough that does not go away,
• Having hot, red, and painful skin or having a painful skin rash with blisters,
• Urinary burning,
• Diarrhea,
• Visual deterioration or loss of vision,
• Headache, neck stiffness, photosensitivity, nausea, or confusion.

Inform 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 may have serious complications. You should also inform your doctor if you have any type of infection that does not go away or reappears. Your doctor may decide that you should not use ustekinumab until the infection has cleared up. You should also contact your doctor if you have any open wounds or ulcers that may become infected.

Skin peeling – the increase in redness and skin peeling on a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are severe skin disorders. If you notice any of these symptoms, you should inform your doctor immediately.

Other side effects

Frequent side effects(they can 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

Rare side effects(they can affect up to 1 in 100 people):

• Dental infections
• Vaginal yeast infections
• Depression
• Stuffy or congested nose
• Bleeding, petechiae, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and facial muscle weakness (“facial paralysis” or “Bell's palsy”), which is usually temporary
• A change in psoriasis with redness and new small skin blisters, sometimes accompanied by fever (psoriasis pustular)
• Skin peeling (exfoliation of the skin)
• Acne

Rare side effects(they can affect up to 1 in 10,000 people):

• Redness and skin peeling on a large area of the body, which can cause itching or pain (dermatitis exfoliativa). Similar symptoms may develop as a natural change in psoriasis symptoms (psoriasis erythroderma)
• Inflammation of small blood vessels, which can cause a skin rash with small red or purple bumps, fever, or joint pain (vasculitis)

Very rare side effects(they can affect up to 1 in 100,000 people):

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national reporting system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Pyzchiva 130 mg concentrate for solution for infusion is administered in a hospital or medical center and does not require patients to conserve or handle it.
• Maintain this medication out of the sight and reach of children.
• Store in refrigerator (2 °C and 8 °C). Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• Do not shake the Pyzchiva vials. Prolonged vigorous shaking may damage the product.

Do not use this medication:

• After the expiration date that appears on the label and packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.
• If the liquid changes color, becomes turbid, or presents foreign particles floating in it (see section 6 “Appearance of Pyzchiva and contents of the packaging”).
• If you know or suspect you have been exposed to extreme temperatures (such as accidental heating or freezing).
• If the product has been vigorously shaken.
• If the seal is broken.

Pyzchiva is for single use. Dispose of the unused diluted infusion solution remaining in the vial or syringe in accordance with local regulations.

Composition of Pyzchiva

• The active ingredient is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 ml.
• The other components are histidine, histidine hydrochloride monohydrate, methionine, disodium edetate, sucrose, polisorbate 80 (E 433), water for injection.

Appearance of Pyzchiva and contents of the container

Pyzchiva is a concentrate for solution for infusion, transparent, colourless or pale yellow in colour. It is presented in a container that contains 1 vial of 30 ml of glass for single use. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion.

Holder of the Marketing Authorization and responsible for manufacturing

Samsung Bioepis NL. B.V.

Olof Palmestraat 10

2616 LR Delft

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: MM/YYYY

Other sources of information

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

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The following information is intended for healthcare professionals only:

Traceability:

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

Instructions for dilution:

Pyzchiva concentrate for solution for infusion must be diluted, prepared and infused by a healthcare professional using aseptic technique.

1. Calculate the dose and the number of vials of Pyzchiva needed based on the patient's weight (see section 3, Table 1). Each vial of 26 ml of Pyzchiva contains 130 mg of ustekinumab.
2. Withdraw and discard a volume of 0.9% sodium chloride solution from the infusion bag equivalent to the volume of Pyzchiva to be added (discard 26 ml of sodium chloride for each vial of Pyzchiva needed: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml). Alternatively, a 250 ml infusion bag containing 0.45% sodium chloride, USP, may be used.
3. Withdraw 26 ml of Pyzchiva from each vial needed and add it to the 250 ml infusion bag. The final volume of the infusion bag must be 250 ml. Mix gently.
4. Visually inspect the diluted solution before infusion. Do not use if particulate matter, colour change or foreign particles are observed.
5. Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion solution must be completed within 72 hours after dilution in the infusion bag. If necessary, the diluted infusion solution may be stored between 2 °C and 8 °C for a maximum of 1 month and at room temperature up to 30 °C for an additional 72 hours after removal from refrigeration, including the infusion period.
6. Use only a infusion system with an in-line filter, sterile, apyrogenic, low protein binding (pore size of 0.2 micrometers).
7. Each vial is for single use only and the unused medicinal product must be discarded in accordance with local regulations.

Storage:

The diluted infusion solution may be stored at room temperature up to 30 °C for a maximum of 72 hours, including the infusion period. If necessary, the diluted infusion solution may be stored between 2 °C and 8 °C for a maximum of 1 month and at room temperature up to 30 °C for an additional 72 hours after removal from refrigeration, including the infusion period. Do not freeze.