Skyrizi 600 mg concentrate for solution for infusion
risankizumab
- 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
Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat patients 16 years and older with moderate to severe Crohn’s disease and adult patients with moderate to severe ulcerative colitis.
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’.
You will begin treatment with Skyrizi with a starting dose which will be given by your doctor or nurse through a drip in your arm (intravenous infusion).
Starting doses
Crohn’s disease
How much?
When?
- When your doctor tells you
- 4 weeks after 1st dose
- 4 weeks after 2nd dose
Ulcerative colitis
How much?
When?
- When your doctor tells you
- 4 weeks after 1st dose
- 4 weeks after 2nd dose
Afterwards, you will receive Skyrizi as an injection under your skin. See package leaflet for Skyrizi 180 mg and 360 mg solution for injection in cartridge.
Maintenance doses
Crohn’s disease
How much?
- 1st maintenance dose: 360 mg
- Further doses: 360 mg
When?
- 4 weeks after the last starting dose (at week 12)
- Every 8 weeks, starting after the 1st maintenance dose
Ulcerative colitis
How much?
- 1st maintenance dose: 180 mg or 360 mg
- Further doses: 180 mg or 360 mg
When?
- 4 weeks after the last starting dose (at week 12)
- Every 8 weeks, starting after the 1st maintenance dose
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Skyrizi 600 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and outer carton after ‘EXP’.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in the original carton in order to protect from light.
Do not shake the Skyrizi vial. Prolonged vigorous shaking can damage the medicine.
Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
- 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.
AbbVie Ltd
Maidenhead
SL6 4UB
UK
Tel: +44 (0)1628 561090
AbbVie S.r.l.
04011 Campoverde di Aprilia
(Latina)
Italy
or
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
This leaflet was last revised in 10/2024
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