Wezenla 45 mg solution for injection

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

WEZENLA 45 mg Injectable Solution

ustekinumab

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

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

This leaflet has been written for the person using the medicine. If you are a parent or caregiver administering WEZENLA to a child, please read this information carefully.

• Keep this leaflet, as you may need to refer to 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 not listed in this leaflet. See section 4.

Contents of this 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 adverse 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 weakening part of the immune system.

What WEZENLA is used for

WEZENLA is used to treat the following inflammatory diseases:

• 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 using 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 treatment with WEZENLA. Your doctor will assess your condition 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 start using WEZENLA. If your doctor believes you are at risk of tuberculosis, they may prescribe medication to treat it.

Be aware of serious adverse effects

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

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 – because immunosuppressants like WEZENLA 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 have or have had a recent infection.
• If you have any new skin lesions or changes in existing lesions 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 diseases related to a weaker 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 are 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 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 accompanied by joint pain.

Heart attacks and strokes

Heart attacks and strokes have been observed in a study of psoriasis patients 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 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 using WEZENLA.
• If you received WEZENLA during pregnancy, inform your infant’s doctor about your treatment with WEZENLA 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 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 birth defects has been observed in babies exposed to WEZENLA in utero. However, experience with WEZENLA in pregnant women is limited. Therefore, it is preferable to avoid using WEZENLA during pregnancy.
• Women of childbearing potential are advised to avoid becoming pregnant and to use adequate contraception while using WEZENLA and for at least 15 weeks after the last dose of WEZENLA.
• Ustekinumab may cross the placenta and reach 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 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 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 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 administration instructions for 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 WEZENLA should be administered

Your doctor will decide the amount 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 doctor will administer the first dose of approximately 6 mg/kg of WEZENLA 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 WEZENLA 8 weeks later, and then every 12 weeks, as an injection under the skin (“subcutaneously”).
• In some patients, after the first subcutaneous injection, 90 mg of WEZENLA will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

Children and adolescents aged 6 years and older

Psoriasis

• Your doctor will determine the correct dose for you, including the amount (volume) of WEZENLA to inject to deliver the correct dose. The appropriate dose for you will depend on your body weight at the time each dose is given.
• 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 doctor will administer the first dose of approximately 6 mg/kg of WEZENLA 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 WEZENLA 8 weeks later, and then every 12 weeks, as an injection under the skin (“subcutaneously”).
• In some patients, after the first subcutaneous injection, 90 mg of WEZENLA will be administered every 8 weeks. Your doctor will decide when you should receive the next dose.

How WEZENLA is administered

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

Consult your doctor if you have any questions about self-injecting.

If you use more WEZENLA than you should

If you have used or been given too much WEZENLA, speak immediately with your doctor 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 doctor or pharmacist. Do not take a double dose to make up for missed doses.

If you stop using WEZENLA

Stopping use of WEZENLA 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 WEZENLA (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, lung-related allergic reactions and lung inflammation have been reported in patients treated with ustekinumab. Inform your doctor immediately if you experience symptoms such as cough, difficulty breathing, or 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 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 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 WEZENLA. These include:

• fever, flu-like symptoms, night sweats, weight loss
• feeling tired or shortness of breath; persistent cough
• skin that feels hot, red, and painful, or a painful blistering skin rash
• burning sensation when urinating
• diarrhoea
• worsening 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 serious infections such as chest infections, skin infections, herpes, or opportunistic infections, which 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 has resolved. Also contact your doctor if you have any open wound or ulcer 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 facial 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, itchy, and painful (bullous pemphigoid)
• Cutaneous lupus or lupus-like syndrome (a red, raised, scaly rash in sun-exposed skin areas, 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 vial in the outer packaging to protect it from light.
• If necessary, individual WEZENLA vials may also be stored at room temperature up to 30 °C for a single period of up to 30 days in their original carton to protect them from light. Record the date when the vial 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 vial has been stored at room temperature (up to a maximum of 30 °C), it must not be returned to the refrigerator. Discard the vial if it is not used within 30 days of storage at room temperature or after the original expiry date, whichever comes first.
• After the solution has been loaded into a disposable syringe, chemical and physical in-use stability has been demonstrated for 24 hours between 15 °C and 25 °C. Do not return to the refrigerator. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user.
• Do not shake WEZENLA vials. Prolonged vigorous shaking may damage the product.

Do not use this medicine:

• After the expiry date stated on the label and packaging following “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 “What WEZENLA looks like and contents of the pack”).
• 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.
• If the seal is broken.

WEZENLA is for single use only. Any unused product remaining in the vial or syringe must be discarded. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging 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 vial contains 45 mg of ustekinumab in 0.5 ml.
• The other components are L-histidine, L-histidine monohydrochloride monohydrate, 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, and from colourless to pale yellow. It is supplied in a pack containing one single-dose 2 ml glass vial. Each vial contains 45 mg of ustekinumab in 0.5 ml of injectable solution.

Marketing Authorisation Holder

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 about 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 European Medicines Agency website: https://www.ema.europa.eu

---

Instructions for use

At the beginning of treatment, a healthcare professional will assist you with your first injection. However, you and your doctor may decide that you can self-inject WEZENLA. In such case, you will be trained on how to inject WEZENLA yourself. Speak with your doctor if you have any questions about administering the injections.

• Do not mix WEZENLA with other injectable liquids.
• Do not shake WEZENLA vials. The medicine may deteriorate if shaken vigorously. Do not use the medicine if it has been shaken vigorously.

1. Check the number of vials and prepare the materials:

Remove the vial(s) from the refrigerator. Let the vial sit for about 30 minutes. This will allow the liquid to reach a comfortable temperature for administration (room temperature).

Inspect the vial(s) to ensure that:

• the number of vials and concentration are correct

• If the dose is 45 mg or less, you will be given one 45 mg WEZENLA vial.

• If the dose is 90 mg, you will be given two 45 mg WEZENLA vials, and you will need to administer two injections. Choose two different injection sites for these injections (for example, one injection in the right thigh and the other in the left thigh), and administer the injections one immediately after the other. Use a new needle and syringe for each injection.

  • it is the correct medicine
  • the expiry date has not passed
  • the vial is not damaged and the seal is intact
  • the solution in the vial is from clear to opalescent and from colourless to slightly yellow
  • the solution has not changed colour, is not cloudy, and contains no foreign particles
  • the solution is not frozen

Children with paediatric psoriasis weighing less than 60 kilograms require a dose lower than 45 mg. Make sure you know the correct amount (volume) to withdraw from the vial and the type of syringe needed for dosing. If you are unsure about the amount or type of syringe required, contact your healthcare professional for further instructions.

Gather all necessary supplies and place them on a clean surface. Include the syringe, needle, antiseptic wipes, cotton wool or gauze, and a sharps container for disposing of sharp objects (see Figure 1).

Figure 1

1. Choose and prepare the injection site:

Select the injection site (see Figure 2).

• WEZENLA is administered by injection under the skin (subcutaneously).
• Suitable injection sites include the upper thigh or the abdominal area (abdomen), at least 5 cm away from the navel.
• Whenever possible, avoid areas of skin showing signs of psoriasis.
• If someone else is administering the injection, they may also choose the upper arm as an injection site.

The areas recommended for injection are indicated in gray.

Figure 2

Prepare the injection site

• Wash your hands thoroughly with soap and lukewarm water.
• Clean the skin at the injection site with an antiseptic wipe.
• Do not touch this area again before administering the injection.

1. Prepare the dose:

• Remove the cap covering the top of the vial (see Figure 3).

Figure 3

• Do not remove the stopper.
• Clean the stopper with an alcohol swab.
• Place the vial on a flat surface.
• Take the syringe and remove the needle cap.
• Do not touch the needle and prevent it from contacting other objects.
• Pierce the rubber stopper with the needle.
• Turn the vial and syringe upside down.
• Pull back the plunger of the syringe to draw up the amount of liquid prescribed by your doctor.
• It is important that the needle tip remains immersed in the liquid at all times to prevent air bubbles from entering the syringe (see Figure 4).

Figure 4

• Remove the needle from the vial.
• Hold the syringe with the needle pointing upward to check for air bubbles inside.
• If there are air bubbles, gently tap the side of the syringe until the bubbles rise to the top (see Figure 5).

Figure 5

• Then push the plunger to expel all the air (but not the liquid).
• Do not place the syringe on any surface and prevent the needle from contacting other objects.

1. Administer the dose:

• Gently pinch the disinfected skin between your thumb and index finger without squeezing tightly. Insert the needle into the skin fold at a 45-degree angle.
• Push the plunger with your thumb slowly and steadily until fully depressed, injecting all the liquid, while maintaining the skin fold gently pinched.
• Once the plunger has been fully depressed, withdraw the needle and release the skin fold.

1. After the injection:

• Press the injection site with an antiseptic wipe for a few seconds after the injection.
• A small amount of blood or liquid may appear at the injection site. This is normal.
• You may apply pressure with a cotton ball or gauze pad for 10 seconds.
• Do not rub the skin at the injection site. You may cover the injection site with a plaster (bandage), if needed.

1. Disposal:

• Used syringes and needles must be placed in a puncture-resistant container, such as a sharps container. For your safety and health, and for the safety of others, never reuse needles or syringes. Dispose of your sharps container according to local regulations.
• Empty vials, antiseptic gauze pads, and other materials may be discarded in the regular trash.