Skyrizi 600 mg concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Skyrizi is and what it is used for
2. What you need to know before you are given Skyrizi
3. How Skyrizi will be given
4. Possible side effects
5. How to store Skyrizi
6. Contents of the pack and other information

This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract. If you have active Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large bowel. If you have active ulcerative colitis you will first be given other medicines. If these medicines do not work well enough or if you cannot take these medicines, you will be given Skyrizi to treat your ulcerative colitis.

Skyrizi reduces the inflammation and can therefore help to reduce the signs and symptoms of your disease.

• if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
• if you have an infection, including active tuberculosis, which your doctor thinks is important.

Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi

• if you currently have an infection or if you have an infection that keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or plan to receive an immunisation (vaccine). You should not be given certain types of vaccines while using Skyrizi.

It is important that your doctor or nurse keep a record of the batch number of your Skyrizi.

Every time you get a new pack of Skyrizi, your doctor or nurse must note down the date and the batch number (which is on the packaging after “Lot”).

Allergic reactions

Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps

Skyrizi is not recommended for children and adolescents under 16 years of age. This is because Skyrizi has not been studied in this age group.

Tell your doctor, pharmacist or nurse:

• if you are using, have recently used or might use any other medicines.
• if you have recently had or are going to have a vaccination. You should not be given certain types of vaccines while using Skyrizi.

If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This is because it is not known how this medicine will affect the baby.

If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.

Skyrizi is not likely to affect your driving and use of machines.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

If you forget or miss the appointment for any of your doses, contact your doctor to reschedule your appointment as soon as you remember.

Do not stop using Skyrizi without talking to your doctor first. If you stop treatment, your symptoms may come back.

Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, cough which will not go away
• warm, red and painful skin, or a painful skin rash with blisters

Your doctor will decide if you can keep using Skyrizi.

Tell your doctor, pharmacist or nurse if you get any of the following side effects

Very common: may affect more than 1 in 10 people

• upper respiratory infections with symptoms such as sore throat and stuffy nose

Common: may affect up to 1 in 10 people

• feeling tired
• fungal skin infection
• injection site reactions (such as redness or pain)
• itching
• headache
• rash
• eczema

Uncommon: may affect up to 1 in 100 people

• small raised red bumps on the skin
• hives (urticaria)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substance is risankizumab. Each vial contains 600 mg of risankizumab in 10 mL solution (60 mg/mL).
• The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections.

Skyrizi is a clear and colourless to slightly yellow liquid in a vial. The liquid may contain tiny white or clear particles.

Each pack contains 1 vial.

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