Yesintek 130 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Yesintek 130 mg concentrate for solution for infusion

ustekinumab

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

This leaflet has been written for the person 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Yesintek is and what it is used for

What Yesintek is

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

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

What Yesintek is used for

Yesintek is used for the treatment of moderate to severe Crohn’s disease – in adults.

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 Yesintek to reduce the signs and symptoms of your disease.

2. What you need to know before using Yesintek

Do not use Yesintek

• 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 Yesintek.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Yesintek. Your doctor will assess your health status before treatment. Make sure to inform your doctor about any medical conditions you have before treatment. Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis. Your doctor will examine you and perform a test for tuberculosis before you start using Yesintek. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Watch for serious side effects

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

Before using Yesintek, tell your doctor:

• If you have ever had an allergic reaction to Yesintek. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – because immunosuppressants like Yesintek weaken part of the immune system, which 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, usually administered by injection) – the risk of developing cancer may be higher.
• If you currently have or recently had an infection, or if you have any skin openings (fistula).
• If you have any new skin lesions or changes in existing lesions within the psoriasis-affected area or on intact skin.
• If you are taking any other treatments 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 combined use of these treatments with Yesintek has not been studied, but it could increase the likelihood of illnesses related to a weakened immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether Yesintek may affect these treatments.
• If you are 65 years of age or older – you may be at higher risk of developing infections.

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

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 sun-exposed areas of skin, 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 Yesintek. 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 unusual sensations on one side of the body, facial paralysis, or speech or vision disturbances.

Children and adolescents

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

Use of Yesintek with other medicines and vaccines

Inform your doctor or pharmacist:

• If you are currently using, have recently used, or might use other medicines.
• If you have recently been vaccinated or are scheduled to receive a vaccine. Certain types of vaccines (live vaccines) should not be given while you are receiving Yesintek.
• If you received Yesintek during pregnancy, inform your infant’s doctor about your Yesintek treatment 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 Yesintek 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 Yesintek in the womb. However, experience with Yesintek in pregnant women is limited. Therefore, it is preferable to avoid using Yesintek during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use adequate contraception while using Yesintek and for at least 15 weeks after the last dose.
• Yesintek can cross the placenta to the fetus. If you received Yesintek 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 Yesintek during pregnancy before the 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 Yesintek 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 Yesintek. Do not do both at the same time.

Driving and using machines

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

Yesintek contains sodium

Yesintek contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free.” However, before administration, Yesintek is mixed with a solution containing sodium. Talk to your doctor if you are on a low-salt diet.

Yesintek contains polysorbate 80

This medicine contains 10.4 mg of polysorbate 80 (E 433) in each 130 mg/26 ml vial, equivalent to 0.4 mg/ml (0.6 mg/kg per day). Polysorbates may cause allergic reactions. Inform your doctor if you have allergies.

3. How to use Yesintek

Yesintek should be used under the guidance and supervision of a physician experienced in the diagnosis and treatment of Crohn's disease.

Your doctor will administer Yesintek 130 mg concentrate for solution for infusion as a drip into a vein in your arm (intravenous infusion) over a period of at least one hour. Ask your doctor when your injections should be given and about follow-up appointments.

Dosage of Yesintek

Your doctor will decide the dose of Yesintek you need to receive and the duration of treatment.

Adults aged 18 years 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 Yesintek as an injection under the skin (subcutaneous injection) 8 weeks later, and subsequently every 12 weeks.

How Yesintek is administered

• The first dose of Yesintek for the treatment of Crohn's disease is given by a doctor as a drip into a vein in the arm (intravenous infusion).

Talk to your doctor if you have any questions about treatment with Yesintek.

If you forget to use Yesintek

If you miss a dose or fail to attend your appointment for administration, speak with your doctor to schedule another appointment.

If you stop treatment with Yesintek

Stopping treatment with Yesintek is not dangerous. However, if you discontinue it, your symptoms may return.

If you have any other 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 Yesintek (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).

Infusion-related reactions – If you are receiving treatment for Crohn's disease, the first dose of Yesintek is administered by intravenous infusion (drip into a vein). Some patients have experienced severe allergic reactions during the infusion.

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, and fever.

If you have a severe allergic reaction, your doctor may decide that you should not use Yesintek 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).

Yesintek may affect your ability to fight infections. Some of these infections may become serious 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 Yesintek. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or having difficulty breathing; persistent cough
• skin that feels hot, red, and painful, or a painful blistering skin rash
• burning sensation when urinating
• diarrhea
• visual deterioration or loss of vision
• headache, neck stiffness, photosensitivity, 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 Yesintek 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 on the skin, sometimes accompanied by fever (pustular psoriasis)
• Skin peeling (exfoliation of the skin)
• 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 on sun-exposed areas of skin, possibly accompanied by joint pain).

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Yesintek

• Yesintek 130 mg concentrate for solution for infusion is administered in a hospital or medical centre and does not need to be stored or handled by patients.
• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2 °C – 8 °C). Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Do not shake the vials of Yesintek. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging after “EXP”. The expiry date refers to the last day of the month indicated.
• If the liquid changes colour, becomes cloudy, or contains floating foreign particles (see section 6 “Description of the product 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 vigorously shaken.
• If the seal is broken.

Yesintek is for single use only. Any unused diluted solution for infusion remaining in the vial or syringe must be discarded according to local regulations.

6. Contents of the pack and other information

Composition of Yesintek

• The active substance is ustekinumab. Each vial contains 130 mg of ustekinumab in 26 ml.
• The other components are disodium edetate dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E 433), sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.
• This medicine contains 10.4 mg of polysorbate 80 (E 433) in each 130 mg/26 ml vial, equivalent to 0.4 mg/ml (0.6 mg/kg per day). Polysorbates may cause allergic reactions. Inform your doctor if you have allergies.

Appearance of the product and contents of the pack

Yesintek is a concentrate for solution for infusion, clear, pale yellow to colourless. It is supplied in a pack containing one single-dose 30 ml glass vial. Each vial contains 130 mg of ustekinumab in 26 ml of concentrate for solution for infusion.

Marketing Authorization Holder

Biosimilar Collaborations Ireland Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate,

Dublin 13, DUBLIN

Ireland, D13 R20R

Manufacturer

Biosimilar Collaborations Ireland Limited

Block B, The Crescent Building, Santry Demesne

Dublin

D09 C6X8

Ireland

Further information on this medicine is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

Other sources of information

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

This 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 administered product should be clearly documented.

Instructions for dilution:

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

1. Calculate the dose and the number of Yesintek vials required based on the patient's body weight (see section 3, Table 1). Each 26 ml vial of Yesintek contains 130 mg of ustekinumab.
2. Withdraw and then discard a volume of 0.9% sodium chloride solution from the 250 ml infusion bag equivalent to the volume of Yesintek to be added (discard 26 ml of sodium chloride per required Yesintek vial: for 2 vials, discard 52 ml; for 3 vials, discard 78 ml; for 4 vials, discard 104 ml).
3. Withdraw 26 ml of Yesintek from each required vial 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, discoloration, or foreign particles are observed.
5. Infuse the diluted solution over a minimum period of one hour. Once diluted, the infusion must be completed within eight hours of dilution in the infusion bag.
6. Use only an infusion system with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometers).
7. Each vial is for single use only, and any unused medicinal product must be discarded in accordance with local regulations.

Storage

If necessary, the diluted solution for infusion may be stored at room temperature. The infusion must be completed within 12 hours after dilution in the infusion bag. Do not freeze. Do not return to the refrigerator after dilution.