Pyzchiva 130 mg Concentrate Solution for Infusion Instructions

130 mg Concentrate Solution for Infusion

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Product Information

Specifications

• Product Name: PyzchivaTM 130 mg concentrate for solution for
  infusion ustekinumab

• Active Substance: Ustekinumab

• Category: Monoclonal Antibody

• Group: Immunosuppressants

Product Usage Instructions

1. What Pyzchiva is and what it is used for

What Pyzchiva is: Pyzchiva contains the active
substance ‘ustekinumab’, a monoclonal antibody that weakens part of
the immune system.

What Pyzchiva is used for: Pyzchiva is used to
reduce the signs and symptoms of Crohn’s disease, an inflammatory
disease of the bowel, when other medicines have not been
effective.

2. What you need to know before you use Pyzchiva

Warnings and Precautions:

• Consult your doctor or pharmacist before using Pyzchiva.

• Your doctor will assess your health before treatment.

• Inform your doctor about any illnesses or recent exposure to
  tuberculosis.

• Watch out for serious side effects like allergic reactions and
  infections.

Before you use Pyzchiva, tell your doctor
if:

• You are uncertain about certain conditions.

• You experience lupus-like reactions or skin issues during
  treatment.

• You have risk factors for heart attack or stroke.

Seek immediate medical attention if you
experience:

• Chest pain, weakness, or abnormal sensations on one side of
  your body.

• Facial droop, speech, or visual abnormalities.

FAQ (Frequently Asked Questions)

Q: What should I do if I experience any side effects while

using Pyzchiva?

A: If you experience any side effects, talk to
your doctor or pharmacist immediately. You can also report any side
effects to help with monitoring new safety information. Refer to
section 4 of the leaflet for details on reporting side effects.

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Package leaflet: Information for the user
PyzchivaTM 130 mg concentrate for solution for infusion ustekinumab
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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.
– Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – 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.
What is in this leaflet
1. What Pyzchiva is and what it is used for 2. What you need to know before you use Pyzchiva 3. How Pyzchiva will be given 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 recognise and bind specifically to certain proteins in the body. Pyzchiva belongs to a group of medicines calledimmunosuppressants’. These medicines work by weakening part of the immune system.
What Pyzchiva is 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 bowel. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough or are intolerant to these medicines, you may be given Pyzchiva to reduce the signs and symptoms of your

disease.
2. What you need to know before you use Pyzchiva
Do not use Pyzchiva: · If you are allergic to ustekinumab or any of the other ingredients of this
medicine (listed in section 6). · If you have an active infection which 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 Pyzchiva.
Warnings and precautions
Talk to your doctor or pharmacist before using Pyzchiva. Your doctor will check how well you are before treatment. Make sure you tell your doctor about any illness you have before treatment. Also tell your doctor if you have recently been near anyone who might have tuberculosis. Your doctor will examine you and do a test for tuberculosis, before you have Pyzchiva. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Look out for serious side effects
Pyzchiva can cause serious side effects, including allergic reactions and infections. You must look out for certain signs of illness while you are taking Pyzchiva. See `Serious side effects’ in section 4 for a full list of these side effects.
Before you use Pyzchiva tell your doctor:
· If you ever had an allergic reaction to Ustekinumab. Ask your doctor if you are not sure.
· 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 cancer.
· If you have been treated for psoriasis with other biologic medicines (a medicine produced from a biological source and usually given by injection) ­ the risk of cancer may be higher.
· If you have or have had a recent infection or if you have any abnormal skin openings (fistulae).
· If you have any new or changing lesions within psoriasis areas or on normal skin. · If you are having any other treatment for psoriasis and/or psoriatic arthritis ­
such as another 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. Using these therapies together with ustekinumab has not been studied. However it is possible it may increase the chance of diseases related to a weaker immune system. · If you are having or have ever had injections to treat allergies ­ it is not known if ustekinumab may affect these. · If you are 65 years of age or over ­ you may be more likely to get infections.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist

before using Pyzchiva.
Some patients have experienced lupus-like reactions including skin lupus or lupus-like syndrome during treatment with ustekinumab. Talk to your doctor right away if you experience a red, raised, scaly rash sometimes with a darker border, in areas of the skin that are exposed to the sun or with joint pains.
Heart attack and strokes
Heart attack and strokes have been observed in a study in patients with psoriasis treated with ustekinumab. Your doctor will regularly check your risk factors for heart disease and stroke in order to ensure that they are appropriately treated. Seek medical attention right away if you develop chest pain, weakness or abnormal sensation on one side of your body, facial droop, or speech or visual abnormalities.
Children and adolescents
Ustekinumab is not recommended for use in children under 18 years of age with Crohn’s disease because it has not been studied in this age group.
Other medicines, vaccines and Pyzchiva
Tell your doctor or pharmacist: · If you are taking, have recently taken or might take any other medicines. · If you have recently had or are going to have a vaccination. Some types of
vaccines (live vaccines) should not be given while using Pyzchiva. · If you received Pyzchiva while pregnant, tell your baby’s doctor about your
Pyzchiva treatment before the 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 the pregnancy unless your baby’s doctor recommends otherwise.
Pregnancy and breast-feeding
· It is preferable to avoid the use of Pyzchiva in pregnancy. The effects of ustekinumab in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using ustekinumab and for at least 15 weeks after the last ustekinumab treatment.
· Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
· Ustekinumab can pass across the placenta to the unborn baby. If you received Pyzchiva during your pregnancy, your baby may have a higher risk for getting an infection.
· It is important that you tell your baby’s doctors and other health care professionals if you received Pyzchiva during your pregnancy before the 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 the pregnancy unless your baby’s doctor recommends otherwise.
· Ustekinumab may pass into breast milk in very small amounts. Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor should decide if you should breast-feed or use ustekinumab – do not do both.

Driving and using machines
Ustekinumab has no or negligible influence on the ability to drive and use machines.

Pyzchiva contains sodium
Pyzchiva contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially `sodium-free’. However, before Pyzchiva is given to you, it is mixed with a solution that contains sodium. Talk to your doctor if you are on a low salt diet.

3. How Pyzchiva will be given
Pyzchiva is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn’s disease.
Pyzchiva 130 mg concentrate for solution for infusion will be given to you by your doctor, through a drip in the vein of your arm (intravenous infusion) over at least one hour. Talk to your doctor about when you will have your injections and follow-up appointments.
How much Pyzchiva is given
Your doctor will decide how much Pyzchiva you need to receive and for how long.

Adults aged 18 years or older
· The doctor will work out the recommended intravenous infusion dose for you based on your body weight.

Your body weight
55 kg > 55 kg to 85 kg

85 kg

Dose 260 mg 390 mg 520 mg

· After the starting intravenous dose, you will have the next dose of 90 mg Pyzchiva by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks thereafter.
How Pyzchiva is given
· The first dose of Pyzchiva for treatment of Crohn’s disease is given by a doctor as a drip in the vein of an arm (intravenous infusion).
Talk to your doctor if you have any questions about receiving Pyzchiva.

If you forget to use Pyzchiva
If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.
If you stop using Pyzchiva
It is not dangerous to stop using ustekinumab. However, if you stop, your symptoms may come back. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Some patients may have serious side effects that may need urgent treatment.
Allergic reactions ­ these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs.
· Serious allergic reactions (anaphylaxis’) are rare in people taking ustekinumab (may affect up to 1 in 1,000 people). Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o 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). Infusion-related reactions ­ If you are being treated for Crohn’s disease, the first dose of ustekinumab is given through a drip into a vein (intravenous infusion). Some patients have experienced serious allergic reactions during the infusion. In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab. Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever. If you have a serious allergic reaction, your doctor may decide that you should not use Pyzchiva again. Infections ­ these may need urgent treatment. Tell your doctor straight away if you notice any of the following signs. · Infections of the nose or throat and common cold are common (may affect up to 1 in 10 people) · Infections of the chest are uncommon (may affect up to 1 in 100 people) · Inflammation of tissue under the skin (cellulitis’) is uncommon (may
affect up to 1 in 100 people) · Shingles (a type of painful rash with blisters) are uncommon (may
affect up to 1 in 100 people)
Ustekinumab may make you less able to fight infections. Some infections could become serious and may include infections caused by viruses, fungi, bacteria (including tuberculosis), or parasites, including infections that mainly occur in people with a weakened immune system (opportunistic infections). Opportunistic infections of the brain (encephalitis, meningitis), lungs, and eye have been reported in patients receiving treatment with ustekinumab.

You must look out for signs of infection while you are using ustekinumab. These include: · fever, flu-like symptoms, night sweats, weight loss · feeling tired or short of breath; cough which will not go away · warm, red and painful skin, or a painful skin rash with blisters · burning when passing water · diarrhoea · visual disturbance or vision loss · headache, neck stiffness, light sensitivity, nausea or confusion.
Tell your doctor straight away if you notice any of these signs of infection. These may be signs of infections such as chest infections, skin infections, shingles or opportunistic infections that could have serious complications. Tell your doctor if you have any kind of infection that will not go away or keeps coming back. Your doctor may decide that you should not use ustekinumab until the infection goes away. Also tell your doctor if you have any open cuts or sores as they might get infected.
Shedding of skin ­ increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions. You should tell your doctor straight away if you notice any of these signs.
Other side effects
Common side effects (may affect up to 1 in 10 people):
· Diarrhoea · Nausea · Vomiting · Feeling tired · Feeling dizzy · Headache · Itching (pruritus’) · Back, muscle or joint pain · Sore throat · Redness and pain where the injection is given · Sinus infection Uncommon side effects (may affect up to 1 in 100 people): · Tooth infections · Vaginal yeast infection · Depression · Blocked or stuffy nose · Bleeding, bruising, hardness, swelling and itching where the injection is given · Feeling weak · Drooping eyelid and sagging muscles on one side of the face (facial
palsy’ or `Bell’s palsy’), which is usually temporary · A change in psoriasis with redness and new tiny, yellow or white skin blisters,

sometimes accompanied by fever (pustular psoriasis) · Peeling of the skin (skin exfoliation) · Acne Rare side effects (may affect up to 1 in 1000 people)
· Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis). Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis).
· Inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps, fever or joint pain (vasculitis)
Very rare side effects (may affect up to 1 in 10,000 people)
· Blistering of the skin that may be red, itchy, and painful (Bullous pemphigoid). · Skin lupus or lupus-like syndrome (red, raised scaly rash on areas of the skin
exposed to the sun possibly with joint pains).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pyzchiva
· Pyzchiva 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.
· Keep this medicine out of the sight and reach of children. · Store in a refrigerator (2°C­8°C). Do not freeze. · Keep the vial in the outer carton in order to protect from light. · Do not shake the Pyzchiva vials. Prolonged vigorous shaking may damage the
medicine.
Do not use this medicine:
· After the expiry date which is stated on the label and the carton after EXP’. The expiry date refers to the last day of that month. · If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6What Pyzchiva looks like and contents of the pack’).
· If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).
· If the product has been shaken vigorously. · If the seal is broken.
Pyzchiva is for single use only. Any diluted infusion solution or unused product remaining in the vial and the syringe should be thrown away in accordance with local requirements.
6. Contents of the pack and other information

What Pyzchiva contains
· The active substance is ustekinumab. Each vial contains 130 mg ustekinumab in 26 mL.
· The other ingredients are Histidine, Histidine hydrochloride monohydrate, Methionine, Disodium edetate, Sucrose, Polysorbate 80, Water for injections.
What Pyzchiva looks like and contents of the pack
Pyzchiva is a clear, colourless to light yellow concentrate for solution for infusion. It is supplied as a carton pack containing 1 single-dose, glass 30 mL vial. Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion.
Marketing Authorisation Holder
Samsung Bioepis UK Limited 5th floor Profile West 950 Great West Road Brentford Middlesex TW8 9ES United Kingdom
Manufacturer Samsung Bioepis NL B.V. Olof Palmestraat 10 2616 LR Delft The Netherlands
This leaflet was last revised in 05/2024.

The following information is intended for healthcare professionals only:
Traceability:
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should 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 Pyzchiva vials needed based on patient weight (see section 3, Table 1). Each 26 mL vial of Pyzchiva contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of Pyzchiva to be added (discard 26 mL sodium chloride for each vial of Pyzchiva needed, for 2 vialsdiscard 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 Injection, 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 in the infusion bag should be 250 mL. Gently mix.
4. Visually inspect the diluted solution before infusion. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
5. Infuse the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed within 72 hours of the dilution in the infusion bag. If necessary, the diluted infusion solution may be kept at 2 °C to 8 °C for up to 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 an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.
Storage The diluted infusion solution may be kept at room temperature up to 30°C for up to 72 hours including infusion period. If necessary, the diluted infusion solution may be kept at 2 °C to 8 °C for up to 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.

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