Skyrizi® 150 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 the following inflammatory diseases:

• Plaque psoriasis in adults
• Plaque psoriasis in children and adolescents from 6 to less than 18 years of age
• Psoriatic arthritis in adults

How Skyrizi works

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

Plaque psoriasis in adults

Skyrizi is used to treat adults with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Plaque psoriasis in children and adolescents

Skyrizi is used to treat children and adolescents from 6 to less than 18 years of age with moderate to severe plaque psoriasis. Skyrizi reduces inflammation and can therefore help reduce symptoms of plaque psoriasis such as burning, itching, pain, redness, and scaling.

Psoriatic arthritis

Skyrizi is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi either alone or in combination with other medicines to treat your psoriatic arthritis.

Skyrizi reduces inflammation and can therefore help to reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rash, psoriatic nail damage, and it may slow down damage to the bone and cartilage in your joints. These effects can ease your normal daily activities, reduce tiredness, and improve your quality of life.

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 under 6 years of age with plaque psoriasis.

Skyrizi is not recommended for children and adolescents under 18 years of age with psoriatic arthritis. 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 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 0.2 mg of polysorbate 20 in each 150 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 pre-filled syringe, 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 an injection under your skin (called a ‘subcutaneous injection’).

How much Skyrizi to use

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 or pharmacist. 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 in the outer carton in order to protect from light.

If needed, you may also store the pre-filled syringe 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.

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

• The active substance is risankizumab. Each pre-filled syringe contains 150 mg of risankizumab in 1 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 pre-filled syringe.

Marketing Authorisation Holder

AbbVie Ltd

Maidenhead

SL6 4UB

UK

Tel: +44 (0)1628 561090

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia

(Latina)

Italy

This leaflet was last revised in 05/2026

To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the Marketing Authorisation Holder.

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

  • In children and adolescents 10 to less than 18 years of age, it is recommended that Skyrizi is given by or under supervision of an adult
  • In children 6 to less than 10 years of age, Skyrizi should be given by an adult
• 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
• 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
• if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe)
• 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

  Ê

FRONT

Brief ID: PROD-2026-000380

Skyrizi® 150 mg solution for injection

in pre-filled syringe

risankizumab

EN Follow the steps below each time you use Skyrizi

STEP 1

Remove the pre-filled syringe from the cardboard sleeve by holding the finger grip.

• Do not hold or pull plunger rod when removing the pre-filled syringe from the sleeve
• Do not remove the needle cover until you are ready to inject

Place the following items on a clean, flat surface:

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

Wash and dry your hands.

STEP 2

Areas to inject

Areas to inject

Choose from these 3 areas to inject:

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

Before the injection, 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
• Do not inject into areas affected by psoriasis

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, they do not need to be removed
• 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
• Do not use if the syringe has been dropped
• Do not use if the syringe has been damaged (for example, the needle is bent or the plunger rod is not connected to the body of the syringe)

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.

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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

Throw away the used syringe in a special disposal container straight after use.

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

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20099623

BACK

New Control Number: 20099623 Size or Drawing Number: SB-8137 (467.4 x 498.5 mm, folded: 125.4 x 50.8 mm) Brief ID: PROD-2026-000380 PDS: CMS.S.03C477

GLM only: PA2026