Patient Information Leaflet

WEZENLA 130mg 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 section4 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 is WEZENLA and what it is used for

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

3.How to use WEZENLA

4.Possible adverse effects

5.Storage of WEZENLA

6.Contents of the pack and additional information

What is WEZENLA

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

WEZENLA belongs to a group of medications called “immunosuppressants”. These medications act by weakening part of the immune system.

How is WEZENLA used

WEZENLA 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 do not tolerate those medications, you may be given WEZENLA to reduce the signs and symptoms of your disease.

No use WEZENLA

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use WEZENLA. Your doctor will check how you are before starting treatment. Make sure to inform your doctor about any illness you have 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 WEZENLA. If your doctor thinks you are at risk of tuberculosis, they may give you medication to treat it.

Be aware of severe side effects

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

Tell your doctor before using WEZENLA:

• If you have ever had an allergic reaction to WEZENLA.Consult with your doctor if you are unsure.
• If you have ever had any type of cancer– this is because the immunosuppressants of the type of WEZENLA weaken part of the immune system. This may increase the risk of having 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 in 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. The use of these treatments in combination with WEZENLA has not been studied. However, it may increase the likelihood of developing immune-related diseases.
• If you are receiving or have ever received injections to treat allergies– it is unknown whether WEZENLA may affect these treatments.
• If you are65 years or older– you are more likely to acquire infections.

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

Some patients have experienced reactions similar to lupus during treatment with ustekinumab, including cutaneous lupus or lupus-like syndrome. Speak with your doctor immediately if you experience a red, elevated, and scaly rash, sometimes with a darker border, in 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 sensation in one side of the body, facial paralysis, or abnormalities in speech or vision.

Children and adolescents

WEZENLA 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 WEZENLA 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 WEZENLA.
• If you received WEZENLA during pregnancy, inform your baby's doctor about your treatment with WEZENLA 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 12 months after birth if you received WEZENLA during pregnancy, unless your baby'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 medication.
• No increased risk of birth defects has been observed in babies exposed to WEZENLA in the womb. However, there is limited experience with WEZENLA in pregnant women. Therefore, it is preferable to avoid using WEZENLA during pregnancy.
• If you are a fertile woman, it is recommended that you avoid becoming pregnant and use suitable contraceptive measures while using WEZENLA and for at least 15weeks after the last WEZENLA treatment.
• WEZENLA may pass through the placenta to the fetus. If you received WEZENLA 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 WEZENLA 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 12 months after birth if you received WEZENLA 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 WEZENLA. Do not do both at the same time.

Driving and operating machinery

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

WEZENLA contains sodium

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

WEZENLA should 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 WEZENLA 130 mg concentrate for infusion via a drip in a vein in your arm (intravenous infusion) for at least one hour. Ask your doctor when they should give you the injections and about follow-up appointments.

What dose of WEZENLA is administered

Your doctor will decide how much WEZENLA you need to receive and the duration of treatment.

Adults 18 years of age and older

How WEZENLA is administered

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

If you forget to use WEZENLA

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

If you interrupt WEZENLA treatment

Stopping WEZENLA 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.

-Difficulty breathing and swallowing

-Low blood pressure, which can cause dizziness or mild headaches

-Swelling of the face, lips, mouth, or throat.

Reactions related to infusion – If you are being treated for Crohn's disease, the first dose of WEZENLA is administered through 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 WEZENLA again.

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

WEZENLA 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 weakened immune systems. 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 WEZENLA. These include:

Inform your doctor immediately if you notice any of these signs of infection, as they may be signs of infections such as pneumonia, skin infections, herpes, or opportunistic infections that could 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 WEZENLA 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 – increased redness and skin peeling on a large area of the body may be symptoms of psoriasis erythroderma or dermatitis exfoliativa, which are serious 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):

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

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

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

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 (see details below). By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Spanish Medicines and Healthcare Products Agency (AEMPS):

www.notificaRAM.es

Do not use this medication:

WEZENLA is for single use. You must dispose of the unused diluted infusion solution remaining in the vial or syringe in accordance with local regulations.

Composition of WEZENLA

Appearance of WEZENLA and contents of the pack

WEZENLA is a concentrate for solution for infusion that is transparent to opalescent, colourless to pale yellow in colour. It is presented in a pack containing 1vial of 30ml of glass single-use vial. Each vial contains 130mg of ustekinumab in 26ml of concentrate for solution for infusion.

Marketing authorisation holder and manufacturer responsible

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 responsible

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

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

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://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:

WEZENLA 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 WEZENLA required based on the patient's weight (see section3, table1). Each vial of 26ml of WEZENLA contains 130mg of ustekinumab.

2.Draw off and discard a volume of 0.9% sodium chloride solution from the infusion bag of 250ml equivalent to the volume of WEZENLA to be added (discard 26ml of sodium chloride for each vial of WEZENLA required: for 2vials, discard 52ml; for 3vials, discard 78ml; for 4vials, discard 104ml).

3.Draw off 26ml of WEZENLA from each vial required and add it to the infusion bag of 250ml. The final volume of the infusion bag must be 250ml. Mix gently.

4.Visually inspect the diluted solution before infusion. Do not use if particles are observed, changes in colour or foreign particles are detected.

5.Infuse the diluted solution over a minimum period of one hour.

6.Use only a infusion system with an in-line filter, sterile, apyrogenic, low protein binding (pore size of 0.2micrometres).

7.Each vial is for single use only and the unused medicinal product must be discarded in accordance with local regulations.

Storage:

If necessary, the diluted infusion solution can be stored at room temperature.

It has been demonstrated that the product is chemically and physically stable for 24hours at a temperature between 15°C and 25°C once diluted between 0.86mg/ml and 2.60mg/ml. Do not refrigerate. Do not freeze.