Prospecto: information for the patient

Skyrizi 180mg injectable solution in cartridge

Skyrizi 360mg injectable solution in cartridge

risankizumab

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section4.

1. What isSkyriziand for what it is used

2. What you need to know before starting to useSkyrizi

3. How to useSkyrizi

4. Possible adverse effects

5. Storage ofSkyrizi

6. Contents of the package and additional information

7. Instructions for use

Skyrizi contains the active ingredient risankizumab.

Skyrizi is used to treat adult patients with:

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

How Skyrizi works

This medication acts by blocking a protein in the body called “IL-23” that causes inflammation.

Crohn's disease

Crohn's disease is an inflammatory disease of the digestive system. If you have active Crohn's disease, it is possible that other medications will be administered first. If these medications do not work well enough, Skyrizi will be administered for the treatment of your Crohn's disease.

Ulcerative colitis

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

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

Do not use Skyrizi

• If you are allergic to risankizumab or any of the other components of this medication (listed in section6).
• If you have an infection that your doctor considers important, for example, active tuberculosis.

Warnings and precautions

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

• If you have an active infection or if you have a recurring infection.
• If you have tuberculosis (TB).
• If you have recently received or plan to receive a vaccine. Certain vaccines should not be administered during treatment with Skyrizi.

It is essential to keep a copy of the batch number of Skyrizi.

Each time you receive a new package of Skyrizi, note the date and batch number (which appears on the package after “Lot”) and store this information in a safe place.

Allergic reactions

Consult 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
• Intense itching on the skin, with a red rash or bumps

Children and adolescents

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

Other medications and Skyrizi

Inform your doctor, pharmacist, or nurse:

• If you are using, have used recently, or may need to use any other medication.
• If you have recently been vaccinated or plan to be vaccinated. Certain vaccines should not be administered during treatment with Skyrizi.

In case of doubt, consult your doctor, pharmacist, or nurse before using Skyrizi and during your treatment.

Pregnancy, contraception, and breastfeeding

If you are pregnant, believe you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. It is necessary to do so because it is not known how this medication may affect the baby.

If you are a woman who may become pregnant, you must use contraception while on treatment with this medication and for at least 21weeks after your last dose of Skyrizi.

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

Driving and operating machinery

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

Skyrizi contains sodium

This medication contains less than 1mmol of sodium (23mg) per cartridge; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication is administered through an injection under the skin (called "subcutaneous injection").

How much Skyrizi to use

You will start treatment with Skyrizi at an initial dose that your doctor or nurse will administer to you through a drip in your arm (intravenous infusion).

Initial doses

Subsequently, you will receive Skyrizi through an injection under the skin.

Maintenance doses

You and your doctor, pharmacist, or nurse will decide if this medication can be injected by you. Do not inject this medication yourself unless your doctor, pharmacist, or nurse has taught you how to do it. It is also possible that a caregiver who has learned to do it will administer the injection to you.

Read the section7 “Instructions for use” at the end of this leaflet before administering the Skyrizi injection.

If you use more Skyrizi than you should

If you have used more Skyrizi than you should or have administered the dose before it was prescribed, consult your doctor.

If you forget to use Skyrizi

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

If you interrupt treatment with Skyrizi

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Severe Adverse Effects

Consult your doctor or seek immediate medical attention if you have any symptoms of severe infection, for example:

• fever, flu-like symptoms, night sweats
• feeling tired or difficulty breathing, persistent cough
• heat, redness, and pain in the skin or a painful, blistering skin rash

Your doctor will decide if you can continue using Skyrizi.

Other Adverse Effects

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

Very Common:may affect more than 1 in 10people

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

Common:may affect up to 1 in 10people

• feeling tired
• skin fungal infections
• reactions at the injection site (such as redness or pain)
• itching
• headache
• rash
• eczema

Rare:may affect up to 1 in 100people

• small red bumps on the skin
• hives (urticaria)

Reporting Adverse Effects

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the cartridge label and on the outer box after EXP.

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

If necessary, it can also be stored outside the refrigerator (at a maximum temperature of 25°C) for a maximum of 24 hours.

Store the cartridge in the original packaging to protect it from light.

Do not use this medication if the liquid is cloudy or contains scales or large particles.

Each prefilled syringe with cartridge is for single use only.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Skyrizi

The active ingredient is risankizumab.

Skyrizi 180mg injectable solution in cartridge

• Each cartridge contains 180mg of risankizumab in 1.2ml of solution.
• The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polisorbate 20 and water for injection.

Skyrizi 360mg injectable solution in cartridge

• Each cartridge contains 360mg of risankizumab in 2.4ml of solution.
• The other components are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polisorbate 20 and water for injection.

Appearance of the product and contents of the package

Skyrizi is a transparent, colorless to yellowish liquid contained in a cartridge. The liquid may contain small, transparent or white particles.

Each package contains 1cartridge and 1body injector.

Holder of the marketing authorization and responsible manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

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

The detailed and updated information on this product is available at the following website 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 include

To request a copy of this leaflet in, or to listen to it in , contact the local representative of the marketing authorization holder.

7.Instructions for use

Read the entire section7 before using Skyrizi

Body injector of Skyrizi

Back view

Side view

Cartridge

Important information you should know before injecting Skyrizi

• You must have received training on how to inject Skyrizi before administering an injection. If you need help, consult your doctor, pharmacist or nurse
• Mark the dates on a calendar to know when you are due for an injection
• 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 use
• Remove the box from the refrigerator and let it reach room temperature, away from direct sunlight, for at least45 and up to 90minutesbefore injection
• Do notget the body injector wet with water or any other liquid
• Do nottouch the start button until you place the body injector loaded with the cartridge on the skin and are ready to inject
• • Only press the start buttononce
• During the injection process, limit physical activity. You can perform moderate physical activities, such as walking, stretching or bending
• Do notdelay the injection of the medicine once the clean cartridge is loaded into the body injector. If you wait, the medicine will dry out and the body injector will stop working
• Do notinject the medicine if the liquid in the inspection window is cloudy or contains scales or large particles. The liquid must be transparent to yellowish and may contain small, transparent or white particles
• Do notshake the box, cartridge or body injector
• Do notre-use the cartridge or body injector

Return this medicine to the pharmacy

• after the expiration date (EXP) indicated
• if the liquid has frozen at any time (even if it has thawed)
• if the cartridge or body injector has fallen or been damaged
• if the perforations in the box are broken
• if the white paper cover of the tray is missing or broken

Follow these steps every time you use Skyrizi