Skyrizi® 180 mg – patient leaflet, side effects, dosage

1. What Skyrizi is and what it is used for

Skyrizi contains the active substance risankizumab.

Skyrizi is used to treat patients 16 years and older with moderate to severe Crohn’s disease and adults with moderate to severe ulcerative colitis.

How Skyrizi works

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.

2. What you need to know before you use Skyrizi

Do not use Skyrizi

• 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.

Warnings and precautions

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 to keep a record of the batch number of your Skyrizi.

Every time you get a new pack of Skyrizi, note down the date and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Serious allergic reactions

Skyrizi can cause serious side effects, including serious allergic reactions (‘anaphylaxis’). 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
• low blood pressure, which can cause dizziness or light-headedness
• severe itching of the skin, with a red rash or raised bumps

Children and adolescents

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

Other medicines and Skyrizi

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.

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 polysorbate and sodium

This medicine contains 0.24 mg of polysorbate 20 in each dose 180 mg dose and 0.48 mg of polysorbate 20 in each 360 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

This medicine contains less than 1 mmol sodium (23 mg) per 180 mg dose and 360 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 1 or 2 injections under your skin (called ‘subcutaneous injections’).

How much Skyrizi to use

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

Afterwards, you will receive Skyrizi as an injection under your skin (called a ‘subcutaneous injection’)

Maintenance doses

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 injection 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

Allergic reactions – these may need urgent treatment. Tell your doctor or get emergency medical help straight away if you notice any of the following signs:

Serious allergic reactions (‘anaphylaxis’) are rare in people taking Skyrizi (may affect up to 1 in a 1 000 people). Signs include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• low blood pressure, which can cause dizziness or light-headedness

Talk to your doctor or get medical help immediately if you have the following symptoms.

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.

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

• 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)

  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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

  By reporting side effects you can help provide more information on the safety of this medicine.

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 syringe(s) in the original carton in order to protect from light.

If needed, you may also store the pre-filled syringe(s) out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.

Do not use this medicine if the liquid is cloudy or contains flakes or large particles.

Each pre-filled syringe is for single use only.

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.

Any unused product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Skyrizi contains

• The active substance is risankizumab. Each pre-filled syringe contains 180 mg of risankizumab in 1.2 mL solution.
• The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20 and water for injections. See section 2, “Skyrizi contains polysorbate and sodium”.

What Skyrizi looks like and contents of the pack

Skyrizi is a clear and colourless to yellow liquid in a pre-filled syringe with needle guard. The liquid may contain tiny white or clear particles.

Each pack contains 1 or 2 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AbbVie Ltd

Maidenhead

SL6 4UB

UK

Tel: +44 (0)1628 561090

Manufacturer

AbbVie Biotechnology GmbH

Knollstrasse

67061 Ludwigshafen

Germany

This leaflet was last revised in 10/2025

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.

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Brief ID: PROD-2025-000404

Skyrizi® 180 mg solution for injection

in pre-filled syringe

risankizumab

EN

DN7943

1. 7. Instructions for use

Please read all of section 7 before using Skyrizi

Skyrizi pre-filled syringe

Plunger rod Finger grip Needle cover

Body of syringe

Important information to know before you inject Skyrizi

• You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help
• Mark the dates on your calendar so you know when to inject Skyrizi
• Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
• Do not inject if the liquid is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles
• Do not shake the syringe(s)
• Wait to remove the needle cover until just before the injection

Return this medicine to the pharmacy

• if the expiry date (EXP) has passed
• if the liquid has ever been frozen (even if thawed)
• if the syringe has been dropped or damaged
• if the carton perforations are broken

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.

• Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
• Keep the syringe in the carton until ready to inject

Follow the steps below each time you use Skyrizi

STEP 1

180 mg dose – 1 syringe

360 mg dose – 2 syringes

Place the following items on a clean, flat surface:

• 1 or 2 pre-filled syringe(s) and 1 or 2 alcohol pad(s) (not included in the carton)
• 1 or 2 cotton ball(s) or gauze pad(s) (not included in the carton)
• Special disposal container (not included in the carton)

Wash and dry your hands.

For the 180 mg dose

1 injection is required.

For the 360 mg dose

2 injections are required, one after the other.

Start with one syringe for the first injection.

STEP 2

Areas to inject

Areas to inject

Choose from these 3 areas to inject:

• front of left thigh
• front of right thigh
• belly (abdomen) at least 5 cm from the belly button (navel)

Before injecting, wipe where you will inject in a circular motion with an alcohol pad.

• Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
• Do not inject through clothes
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks.

For the 360 mg dose

• Use a new injection site for each injection.
• For the second syringe, inject at least 3 cm away from the first injection. Do not inject into the same place.

STEP 3

Check liquid

Hold the syringe with the covered needle pointing down, as shown.

Check the liquid in the syringe.

• It is normal to see bubbles in the window
• The liquid should look clear to yellow and may contain tiny white or clear particles

• Do not use if the liquid is cloudy or contains flakes or large particles

  STEP 4

  Removing the needle cover:

  • Hold the syringe in one hand between the finger grip and needle cover
  • With the other hand, gently pull the needle cover straight off
  • Do not hold or pull the plunger rod when removing the needle cover
  • You may see a drop of liquid at the end of the needle. This is normal
  • Throw away the needle cover
  • Do not touch the needle with your fingers or let the needle touch anything

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

Needle guard

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.

• The needle guard will not activate unless all the liquid is injected.
• Speak to your doctor, pharmacist or nurse if you think you have not given a full dose.

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

180 mg dose

1 injection is required

360 mg dose

2 injections are required

For the 180 mg dose

1 injection is required.

For the 360 mg dose

2 injections are required

• Repeat Steps 2 through 6 with the second syringe.
• 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 right away after use.

• Do not throw away used syringes in the household waste
• Your doctor, pharmacist or nurse will tell you how to return the full special disposal container

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BACK

New Control Number: DN7943 Size or Drawing Number: SB-8137 (Flat size: 467.4 x 498.5mm, Folded size: 125.4 x 50.8mm)