Skyrizi 360 mg solution for injection in cartridge

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Skyrizi 180 mg solution for injection in cartridge

Skyrizi 360 mg solution for injection in cartridge

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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally and must not be given to others, even if they have the same symptoms as you, as 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.

Contents of the leaflet

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 adult patients with:

• moderate to severe Crohn’s disease
• moderate to severe ulcerative colitis

How Skyrizi works

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

Crohn’s disease

Crohn’s disease is an inflammatory condition of the digestive tract. If you have active Crohn’s disease, you may first be given other medications. If these medications do not work well enough, Skyrizi will be given to treat your Crohn’s disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory condition of the large intestine. If you have active ulcerative colitis, you may first be given other medications. If these medications do not work well enough or if you cannot take them, Skyrizi will be given to treat your ulcerative colitis.

Skyrizi reduces inflammation and, therefore, may help reduce the signs and symptoms of your disease.

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 serious, for example, active tuberculosis.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting 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 package of Skyrizi, write down the date and the batch number (shown on the package after “Lot”) 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, for example:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• low blood pressure, which may cause dizziness or lightheadedness
• severe 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 the use of Skyrizi has not been studied in this age group.

Other medicines and Skyrizi

Tell 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 given 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, talk to your doctor before using this medicine. You must do so because it is not known how this medicine may affect the baby.

If you are a woman who can become pregnant, you should 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, talk to your doctor before using this medicine.

Driving and using machines

It is unlikely that Skyrizi will affect your ability to drive or use machines.

Skyrizi contains polysorbate and sodium

This medicine contains 0.24 mg of polysorbate 20 in each 180 mg dose and 0.48 mg of polysorbate 20 in each 360 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 cartridge; this is essentially “sodium-free”.

3. How to use Skyrizi

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

This medicine is administered by injection under the skin (called "subcutaneous injection").

How much Skyrizi to use

You will start treatment with Skyrizi at an initial dose administered by your doctor or nurse through an intravenous infusion (into the vein) in your arm.

Initial doses

Later, you will receive Skyrizi via a subcutaneous injection.

Maintenance Dose

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

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

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 inject Skyrizi, administer the missed 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 discontinue 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 experiences 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 spots on the skin
• hives (urticaria)

Reporting of adverse effects

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may 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 after 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 packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Skyrizi

The active substance is risankizumab.

Skyrizi 180 mg solution for injection in cartridge

• Each cartridge contains 180 mg of risankizumab in 1.2 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”.

Skyrizi 360 mg solution for injection in cartridge

• Each cartridge contains 360 mg of risankizumab in 2.4 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”.

Appearance of the product and contents of the pack

Skyrizi is a clear, colourless to yellow liquid contained in a cartridge. The liquid may contain small transparent or white particles.

Each pack contains 1 cartridge and 1 body-worn injector.

Marketing Authorization Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization 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 about this product is available below or on the outer packaging by scanning the QR code with a smartphone. The same information is also available at 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

1. Instructions for use

Read all of section 7 before using Skyrizi

Skyrizi Body Injector

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 assistance, consult your doctor, pharmacist, or nurse.
• Mark the dates on a calendar to keep track of when your next Skyrizi injection is due.
• The single-use body injector is designed for use only with the Skyrizi cartridge.
• Keep Skyrizi in its original packaging to protect the medicine from light until ready to use.
• Remove the box from the refrigerator and allow it to reach room temperature, away from direct sunlight, for at least 45 and up to 90 minutes before injection.
  • The body injector will not work if Skyrizi is not allowed to warm to room temperature for at least 45 minutes.
• Do not get the body injector wet with water or any other liquid.
• Do not press the start button until the body injector loaded with the cartridge is placed on the skin and you are ready to inject.
• The start button can be pressed only once.
• Physical activity should be limited during the injection process. Moderate activities such as walking, stretching, or bending are acceptable.
• Do not delay injecting the medicine once the clean cartridge has been loaded into the body injector. If delayed, the medicine may dry out and the body injector will no longer function.
• Do not inject the medicine if the liquid in the viewing window appears cloudy or contains flakes or large particles. The liquid should be clear to yellow and may contain tiny transparent or white particles.
• Do not shake the box, cartridge, or body injector.
• Do not reuse the cartridge or body injector.

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 cartridge or body injector has been dropped or damaged;
• if the perforations on the box are broken;
• if the white paper cover of the tray is missing or broken.

Follow the steps below each time you use Skyrizi