Skyrizi 150 mg solution for injection in pre-filled syringe

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Skyrizi 150mg solution for injection in pre-filled syringe

risankizumab

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Skyrizi is and what it is used for
2. What you need to know before using 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 the following inflammatory conditions:

• Plaque psoriasis
• Psoriatic arthritis

How Skyrizi works

This medicine works by blocking a protein in the body called "IL-23" that causes inflammation.

Plaque psoriasis

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

Psoriatic arthritis

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

Skyrizi reduces inflammation and, thus, can help reduce pain, stiffness, and swelling in and around your joints, pain and stiffness in your spine, psoriatic skin rashes, and nail damage due to psoriasis, as well as slow down bone and cartilage damage in your joints. These effects may make it easier for you to carry out daily activities, reduce fatigue, and improve your quality of life.

2. What you need to know before using Skyrizi

Do not use Skyrizi

• if you are allergic to risankizumab or to any of the other ingredients of this medicine (listed in section 6).
• if you have an infection that your doctor considers significant, for example, active tuberculosis.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Skyrizi and during your treatment:

• if you currently have an infection or if you have a recurring infection.
• if you have tuberculosis (TB).
• if you have recently received or are planning to receive a vaccine. Certain vaccines should not be given during treatment with Skyrizi.

It is important to keep a record of the Skyrizi batch number.

Each time you receive a new Skyrizi pack, write down the date and the batch number (shown on the pack after “Batch”) and keep this information in a safe place.

Severe allergic reactions

Skyrizi may cause serious side effects, including severe allergic reactions (“anaphylaxis”). Contact your doctor or seek immediate medical attention if you notice any signs of an allergic reaction while receiving Skyrizi, such as:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or lightheadedness
• intense itching of the skin, with a red rash or bumps

Children and adolescents

Skyrizi is not recommended for children and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and Skyrizi

Inform your doctor, pharmacist, or nurse:

• if you are taking, have recently taken, or might need to take any other medicines.
• if you have recently been vaccinated or plan to be vaccinated. Certain vaccines should not be administered during treatment with Skyrizi.

If you are unsure, consult your doctor, pharmacist, or nurse before using Skyrizi and during your treatment.

Pregnancy, contraception, and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. This is necessary because it is not known how this medicine may affect the baby.

If you are a woman of childbearing potential, you must use contraception during treatment with this medicine and for at least 21 weeks after your last dose of Skyrizi.

If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine.

Driving and using machines

It is unlikely that Skyrizi will affect your ability to drive or operate machinery.

Skyrizi contains polysorbate and sodium

This medicine contains 0.2 mg of polysorbate 20 in each 150 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

This medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe; this is essentially “sodium-free”.

3. How to use Skyrizi

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered by an injection under the skin (called a “subcutaneous injection”).

How much Skyrizi to use

Each dose is 150 mg given as a single injection. After the first dose, the next dose will be administered 4 weeks later, and then every 12 weeks.

You and your doctor, pharmacist, or nurse will decide whether you can inject this medicine yourself. You must not self-inject this medicine unless your doctor, pharmacist, or nurse has trained you how to do so. Alternatively, a caregiver who has been trained may administer the injection.

Read section 7 “Instructions for use” at the end of this leaflet before administering your Skyrizi injection.

If you use more Skyrizi than you should

If you have used more Skyrizi than you should, or if you have administered the dose earlier than prescribed, consult your doctor.

If you forget to use Skyrizi

If you forget to administer Skyrizi, inject a dose as soon as you remember. If in doubt, consult your doctor.

If you stop using Skyrizi

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Allergic reactions – may require urgent treatment. Inform your doctor or seek immediate medical help if you experience any of the following signs:

Severe allergic reactions ("anaphylaxis") are rare in patients using Skyrizi (may affect up to 1 in 1,000 people). Signs include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or lightheadedness

Consult your doctor or seek immediate medical attention if you have any of the following symptoms.

Symptoms of a serious infection, for example:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, persistent cough
• warmth, redness, and pain in the skin or a painful skin rash with blisters

Your doctor will decide whether you can continue using Skyrizi.

Other adverse effects

Tell your doctor, pharmacist, or nurse if you notice any of the following adverse effects.

Very common: may affect more than 1 in 10 people

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion

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 red lumps on the skin
• hives (urticaria)

Reporting of adverse effects

If you experience adverse effects, talk to your doctor, pharmacist, or nurse, including any possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Skyrizi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the pen and on the outer carton following EXP.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the pre-filled pen in the original packaging to protect it from light.

If necessary, the pre-filled pen may also be stored outside the refrigerator (at a maximum temperature of 25 °C) for up to 24 hours, while remaining in the original packaging to protect it from light.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Skyrizi

• The active substance is risankizumab. Each pre-filled syringe contains 150 mg of risankizumab in 1 ml of solution.
• The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections. See section 2, “Skyrizi contains polysorbate and sodium”.

Nature and contents of the container

Skyrizi is a clear, colourless to yellow liquid contained in a pre-filled syringe with a needle shield. The liquid may contain tiny transparent or white particles.

Each pack contains 1 pre-filled syringe.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer responsible for batch release

AbbVie S.r.l.

04011 Campoverde di Aprilia

(Latina)

Italy

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Detailed and up-to-date information on this product is available below or on the outer packaging by scanning the QR code using a smartphone. The same information is also available on the following website:

www.skyrizi.eu

QR code to be included

To request a copy of this leaflet in , , or to listen to it in

7. Instructions for use

Read all of section 7 before using Skyrizi

Skyrizi pre-filled syringe

Important information you should know before injecting Skyrizi

• You must have received training on how to inject Skyrizi before self-administering an injection. If you need help, consult your doctor, pharmacist, or nurse.
• Mark the dates on a calendar to keep track of when your next Skyrizi injection is due.
• Keep Skyrizi in its original packaging to protect the medicine from light until the time of use.
• Do not inject the medicine if the liquid is cloudy or contains flakes or large particles. The liquid should be clear to yellow in color and may contain tiny transparent or white particles.
• Do not shake the syringe.
• Wait to remove the needle cap until immediately before injection.

Return this medicine to the pharmacy

• after the expiry date (EXP) indicated.
• if the liquid has ever been frozen (even if it has been thawed).
• if the syringe has been dropped or damaged.
• if the perforations on the box are broken.

For a more comfortable injection: take the box out of the refrigerator and allow it to reach room temperature, away from direct sunlight, for 15 to 30 minutes before injection.

• Skyrizi must not be heated in any other way (e.g., in a microwave or in hot water).
• Keep the syringe in the box until the time of injection.

Follow the steps below every time you use Skyrizi