Wezenla 90 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

WEZENLA 45 mg solution for injection in pre-filled syringe

WEZENLA 90 mg solution for injection in pre-filled syringe

ustekinumab

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

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. If you are the parent or caregiver of a child who will be administered WEZENLA, please read this information carefully.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since 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.

Contents of the leaflet

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

1. What WEZENLA is and what it is used for

What WEZENLA is

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

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

What WEZENLA is used for

WEZENLA is used to treat the following inflammatory conditions:

• Plaque psoriasis – in adults and children from 6 years of age
• 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 causing inflammation affecting the skin and nails. WEZENLA reduces inflammation and other signs of the disease.

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

WEZENLA is used in children and adolescents from 6 years of age 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 WEZENLA 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 these medications, you may be given WEZENLA to reduce the signs and symptoms of your disease.

2. What you need to know before starting to use WEZENLA

Do not use WEZENLA

• 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 important.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use WEZENLA. Your doctor will check your health status before each treatment. Make sure to inform your doctor about any medical conditions you 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 WEZENLA. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Be aware of serious side effects

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

Before using WEZENLA, tell your doctor:

• If you have ever had an allergic reaction to WEZENLA. Consult your doctor if you are unsure.
• If you have ever had any type of cancer – this is because immunosuppressants like WEZENLA weaken part of the immune system. This may increase the risk of developing cancer.
• If you have previously received treatment 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 have or have recently had an infection.
• If you have any new skin lesions or changes in existing lesions, either within the psoriasis area or on intact skin.
• If you are currently receiving any other treatment 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 WEZENLA has not been studied. However, it may increase the likelihood of developing illnesses related to a weakened immune system.
• If you are receiving or have ever received allergy shots (immunotherapy) – it is unknown whether WEZENLA may affect these treatments.
• If you are 65 years of age or older – you may have a higher risk of developing infections.

If you are unsure whether any of these conditions apply to you, speak with your doctor or pharmacist before using WEZENLA.

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

In a study conducted in psoriasis patients treated with ustekinumab, heart attacks and strokes have been observed. 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 abnormalities.

Children and adolescents

The use of WEZENLA is not recommended in children under 6 years of age with psoriasis, in 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 WEZENLA 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) must not be administered while you are receiving WEZENLA.
• If you received WEZENLA during pregnancy, inform your infant’s doctor about your WEZENLA 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 WEZENLA during pregnancy, unless your infant’s doctor recommends otherwise.

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 birth defects has been observed in babies exposed to WEZENLA in the womb. However, experience with WEZENLA in pregnant women is limited. Therefore, it is preferable to avoid using WEZENLA during pregnancy.
• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and to use appropriate contraception while using WEZENLA and for at least 15 weeks after the last dose.
• Ustekinumab may cross the placenta to the fetus. If you received WEZENLA during pregnancy, your infant may have an increased risk of developing an infection.
• It is important to inform your infant’s doctors and other healthcare professionals if you received WEZENLA 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 WEZENLA during pregnancy, unless your infant’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 breastfeed. You and your doctor will decide whether to breastfeed or use WEZENLA. Do not do both simultaneously.

Driving and use of machines

The influence of WEZENLA on the ability to drive and use machines is negligible or none.

WEZENLA contains polysorbate 80

WEZENLA contains 0.02 mg (45 mg/0.5 ml) or 0.04 mg (90 mg/1.0 ml) of polysorbate 80 (E 433) per dosage unit, equivalent to 0.04 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use WEZENLA

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

Always follow exactly the dosing instructions provided by your physician. If in doubt, consult your physician. Ask your physician when your injections should be administered and about follow-up appointments.

How much WEZENLA to administer

Your physician will determine the dose of WEZENLA 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 WEZENLA. 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 physician will administer the first dose of approximately 6 mg/kg of WEZENLA as an intravenous infusion (through a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of WEZENLA 8 weeks later, and then every 12 weeks, by subcutaneous injection (“subcutaneous route”).
• In some patients, after the first subcutaneous injection, 90 mg of WEZENLA will be administered every 8 weeks. Your physician will decide when you should receive the next dose.

Children and adolescents aged 6 years and older

Psoriasis

• Your physician will determine the correct dose for you, including the amount (volume) of WEZENLA to inject to deliver the correct dose. The appropriate dose depends on your body weight at the time each dose is given.
• A 45 mg vial is available for children who require less than the full 45 mg dose.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of WEZENLA per kg of body weight.
• If you weigh between 60 kg and 100 kg, the recommended dose is 45 mg of WEZENLA.
• If you weigh more than 100 kg, the recommended dose is 90 mg of WEZENLA.
• After the initial dose, you will receive the next dose 4 weeks later, and subsequently every 12 weeks.

Children weighing at least 40 kg

Crohn’s disease

• During treatment, your physician will administer the first dose of approximately 6 mg/kg of WEZENLA as an intravenous infusion (through a vein in the arm). After the initial dose, you will receive the next dose of 90 mg of WEZENLA 8 weeks later, and then every 12 weeks, by subcutaneous injection (“subcutaneous route”).
• In some patients, after the first subcutaneous injection, 90 mg of WEZENLA will be administered every 8 weeks. Your physician will decide when you should receive the next dose.

How WEZENLA is administered

• WEZENLA is administered by subcutaneous injection (“subcutaneous route”). At the beginning of your treatment, medical or nursing staff may administer WEZENLA to you.
• However, you and your physician may decide that you can self-inject WEZENLA. In this case, you will be trained on how to self-administer WEZENLA.
• For instructions on how to inject WEZENLA, see “Instructions for use” at the end of this leaflet.

Consult your physician if you have any questions about self-injection.

If you use more WEZENLA than you should

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

If you forget to use WEZENLA

If you miss a dose, speak with your physician or pharmacist. Do not take a double dose to make up for missed doses.

If you stop using WEZENLA

Stopping treatment with WEZENLA 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 physician 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 lung 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 WEZENLA 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)

WEZENLA may affect your ability to fight infections. Some of these infections could 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 WEZENLA. 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, stiff neck, photosensitivity, nausea, or confusion.

Contact your doctor immediately if you notice any of these signs of infection, as they may indicate serious infections such as chest infections, skin infections, herpes, or opportunistic infections that could lead to severe 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 WEZENLA 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 blockage or congestion
• Bleeding, bruising, hardening, swelling, and itching at the injection site
• Feeling weak
• Drooping eyelid and muscle weakness 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 sun-exposed areas of skin, possibly accompanied by joint pain).

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

5. Storage of WEZENLA

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Keep the pre-filled syringe in the outer packaging to protect it from light.
• If necessary, individual pre-filled syringes of WEZENLA may also be stored at room temperature up to 30 °C for a maximum single period of up to 30 days in their original carton to protect them from light. Record the date when the pre-filled syringe is first removed from the refrigerator and the date when it must be discarded. The discard date must not exceed the original expiry date printed on the carton. Once a syringe has been stored at room temperature (up to a maximum of 30 °C), it must not be returned to the refrigerator. Discard the syringe if it is not used within 30 days of storage at room temperature or by the original expiry date, whichever comes first.
• Do not shake the pre-filled syringes of WEZENLA. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging after “CAD” or “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 “Description of WEZENLA 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.

WEZENLA 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 medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of WEZENLA

• The active substance is ustekinumab. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml or 90 mg of ustekinumab in 1 ml.
• The other components are L-histidine, monohydrated L-histidine hydrochloride, polysorbate 80 (E 433), sucrose, and water for injections.

Appearance of WEZENLA and contents of the pack

WEZENLA is an injectable solution ranging from clear to opalescent, colourless to pale yellow. It is supplied in a pack containing one single-use 1 ml glass pre-filled syringe. Each pre-filled syringe contains 45 mg of ustekinumab in 0.5 ml or 90 mg of ustekinumab in 1 ml of injectable solution.

Marketing Authorisation Holder and Manufacturer

Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland

Marketing Authorisation Holder

Amgen Technology (Ireland) UC,
Pottery Road,
Dun Laoghaire,
Co Dublin,
Ireland

Manufacturer

Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet

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 USE

These Instructions for Use provide information on how to inject WEZENLA using a pre-filled syringe.

This pre-filled syringe delivers WEZENLA via an injection under the skin (subcutaneous). Refer to the package leaflet for information about the medicine.

Use of the WEZENLA pre-filled syringe:

• It is important that you do not attempt to administer the injection unless you have been trained to do so by your doctor or a healthcare professional.

• In children aged 12 years or older with psoriasis and weighing 60 kg or more, it is recommended that WEZENLA be administered by a parent or caregiver or under their supervision.

• Do not use the pre-filled syringe if the carton is damaged or if the seal is broken.

• Do not use the pre-filled syringe after the expiry date stated on the label.

• Do not shake the pre-filled syringe.

• Do not remove the needle cap from the pre-filled syringe until you are ready to perform the injection.

• Do not use the pre-filled syringe if it has been frozen.

• Do not use the pre-filled syringe if it has been dropped on a hard surface. Even if no damage is visible, some parts of the syringe may have broken. Use a new pre-filled syringe, if available, and contact your doctor or healthcare professional.

You should discard any unused product remaining in the syringe. Medicines must not be disposed of via sewage systems or in household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.