Active ingredient
- risankizumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 41042/0033.
Skyrizi 75 mg solution for injection in pre-filled syringe (Great Britain)
Package leaflet: Information for the patient
Skyrizi 75 mg solution for injection in pre-filled syringe
risankizumab
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Skyrizi is and what it is used for
2. What you need to know before you use Skyrizi
3. How to use Skyrizi
4. Possible side effects
5. How to store Skyrizi
6. Contents of the pack and other information
7. Instructions for use
1. What Skyrizi is and what it is used for
Skyrizi contains the active substance risankizumab.
Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
How Skyrizi works
This medicine works by stopping a protein in the body called ‘IL-23’, which causes inflammation. It reduces the inflammation. It also reduces symptoms of psoriasis such as burning, itching, pain, redness and scaling.
2. What you need to know before you use Skyrizi
Do not use Skyrizi
Warnings and precautions
Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
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:
Children and adolescents
Skyrizi is not recommended for children and adolescents under 18 years of age. This is because Skyrizi has not been studied in this age group.
Other medicines and Skyrizi
Tell your doctor, pharmacist or nurse:
If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.
Pregnancy, contraception and breast-feeding
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.
Driving and using machines
Skyrizi is not likely to affect your driving and use of machines.
Skyrizi contains sorbitol and sodium
This medicine contains 68 mg sorbitol per 150 mg dose.
This medicine contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially ‘sodium-free’.
3. How to use Skyrizi
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
This medicine is given as 2 injections under your skin (called ‘subcutaneous injections’).
How much Skyrizi to use
The dose is 150 mg given as two 75 mg injections.
How much?
When?
1st dose
150 mg (two 75 mg injections)
When your doctor tells you
2nd dose
150 mg (two 75 mg injections)
4 weeks after 1st dose
Further doses
150 mg (two 75 mg injections)
Every 12 weeks starting after 2nd dose
You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself. Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse. A caregiver may also give your injections after they have been trained.
Read section 7 ‘Instructions for use’ at the end of this leaflet before injecting Skyrizi yourself.
If you use more Skyrizi than you should
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.
If you forget to use Skyrizi
If you forget to use Skyrizi, inject a dose as soon as you remember. Talk to your doctor if you are not sure what to do.
If you stop using Skyrizi
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as:
Your doctor will decide if you can keep using Skyrizi.
Other side effects
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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Reporting of side effects
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.
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Skyrizi
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 syringe label and outer carton after ‘EXP’.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the pre-filled syringes in the original carton in order to protect from light.
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. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Skyrizi contains
What Skyrizi looks like and contents of the pack
Skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.
Each pack contains 2 pre-filled syringes and 2 alcohol pads.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 01/2021
Other sources of information
Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone. The same information is also available at the following URL:
www.skyrizi.eu
To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the local representative of the Marketing Authorisation Holder.
7. Instructions for use
Please read all of section 7 before using Skyrizi
Important information to know before you inject Skyrizi
Return this medicine to the pharmacy
For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
Follow the steps below each time you use Skyrizi
STEP 1
Place the following items on a clean, flat surface:
Wash and dry your hands.
Start with one syringe for the first injection.
For a full dose, 2 injections are required, one after the other.
STEP 2
Choose from these 3 areas to inject:
For the second syringe, inject at least 3 cm away from the first injection. Do not inject into the same place.
Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
STEP 3
Hold the syringe with the covered needle pointing down, as shown.
Check the liquid in the syringe.
STEP 4
Removing the needle cover:
STEP 5
Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.
Gently pinch the area of cleaned skin with your other hand and hold it firmly.
Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement. Keep the syringe steady at the same angle.
STEP 6
Slowly push the plunger rod all the way in until all of the liquid is injected.
Pull the needle out of the skin while keeping the syringe at the same angle.
Slowly take your thumb off the plunger rod. The needle will then be covered by the needle guard.
Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.
Do not rub the skin where you have injected. You may have slight bleeding from where you injected. This is normal
STEP 7
For a full dose, two injections are needed, one after the other.
Inject the second syringe straight after the first injection but at least 3 cm away from the first injection
STEP 8
Throw away used syringes in a special disposal container straight after use.
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