Skyrizi 150 mg solucion inyectable en jeringa precargada

Patient Information Leaflet

Skyrizi 150mg pre-filled syringe injectable solution

risankizumab

Read this 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 only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

Skyrizi contains the active ingredient risankizumab.

Skyrizi is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis

How Skyrizi works

This medication acts 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, may help reduce the symptoms of plaque psoriasis such as itching, burning, pain, redness, and scaling.

Psoriatic arthritis

Skyrizi is used to treat psoriatic arthritis in adults. Psoriatic arthritis is a disease that causes inflammation of the joints and psoriasis. If you have active psoriatic arthritis, it is possible that you will first be administered other medications. If these medications do not work well enough, you will be administered Skyrizi alone or in combination with other medications for the treatment of your psoriatic arthritis.

Skyrizi reduces inflammation and, therefore, may help reduce pain, stiffness, and inflammation in your joints and around them, pain and stiffness in your spine, psoriatic skin eruptions, and nail damage due to psoriasis, as well as slow down damage to your joint bone and cartilage. These effects may make it easier for you to perform daily activities, reduce fatigue, and improve your quality of life.

No use Skyrizi

• If you are allergic to risankizumab or any of the other components of this medication (listed in section 6).
• 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 currently have an 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 Skyrizi batch number.

Each time you receive a new Skyrizi package, note the date and batch number (which appears on the package after “Batch”) 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 18 years 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, think 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 a minimum of 21 weeks after your last Skyrizi dose.

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

Driving and operating machines

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

Skyrizi contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per prefilled syringe; essentially, it is “sodium-free.”

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

This medication is administered through a subcutaneous injection.

How Much Skyrizi to Use

Each dose is 150 mg administered through 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 if this medication can be injected by yourself. Do not inject this medication yourself unless your doctor, pharmacist, or nurse have taught you how to do it. It is also possible that a caregiver who has learned how to do it may administer the injection.

Read Section 7 “Instructions for Use” at the end of this prospectus 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 will experience them.

Severe Adverse Effects

Consult your doctor or seek immediate medical attention if you experience 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 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
• skin fungal infections
• reactions at the injection site (such as redness or pain)
• itching
• headache
• rash
• eczema

Uncommon:may affect up to 1 in 100 people

• 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 thenational notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about 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 syringe label and on the outer box after CAD.

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

Store the preloaded syringe in the original packaging to protect it from light.

If necessary, you can also store the preloaded syringe outside the refrigerator (at a maximum temperature of 25°C) for a maximum of 24 hours 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.

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

Composition of Skyrizi

• The active ingredient 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, polisorbate 20, and water for injection.

Appearance of the product and contents of the pack

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

EACH PACK CONTAINS 1 PRE-FILLED SYRINGE

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia

(Latina)

Italy

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.

Last update of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Further information on this product is available on the following website:

www.skyrizi.eu

QR code to include

To request a copy of this leaflet inbraille, or to listen to it in ,please contact the representative of the marketing authorisation holder in your country.

7.Instructions for use

Read the entire section7 before using Skyrizi

Pre-filled syringe of Skyrizi

Plunger Needle guard Cap

Syringe body

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 need to inject Skyrizi
• Keep Skyrizi in its original packaging to protect the medicine from light until you use it
• Do not inject the medicine if the liquid is cloudy or contains scales or large particles. The liquid must be clear, colourless to yellowish and may contain small, transparent or white particles
• Do not shake the syringe
• Wait to remove the cap from the needle until just before the injection

Return this medicine to the pharmacy

• after the expiry date (EXP) indicated
• if the liquid has frozen at any time (even if it has thawed)
• if the syringe has fallen or been damaged
• if the perforations on the box are torn

For a more comfortable injection: Take the box out of the refrigerator and leave it at room temperature, away from direct sunlight, for15 to 30minutesbefore the injection.

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

Follow these steps every time you use Skyrizi