Skyrizi 150 mg solucion inyectable en pluma precargada

Patient Information Leaflet

Skyrizi 150mg pre-filled syringe

risankizumab

Read this leaflet carefully before you start using this medicine because 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What Skyrizi is and what it is used for

2.What you need to know before you start using Skyrizi

3.How to use Skyrizi

4.Possible side effects

5.Storage of Skyrizi

6.Contents of the pack and additional information

7.Instructions for use

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 other medications will be administered to you first. If these medications do not work well enough, Skyrizi will be administered 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.

Do not 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 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 “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 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 1 mmol of sodium (23 mg) per prefilled syringe; this is essentially “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

Rare: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 pen label and on the outer box after CAD.

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

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

If necessary, you can also store the preloaded pen 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.

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

Composition of Skyrizi

• The active ingredient is risankizumab. Each pre-filled pen 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 transparent, colorless to yellowish liquid contained in a pre-filled pen. The liquid may contain small, transparent or white particles.

EACH PACK CONTAINS 1 PRE-FILLED PEN.

Marketing Authorization Holder and Responsible Person

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet

Other sources of information

The detailed information on this medicinal product 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 braille, large print or to listen to it in audio, please contact the local representative of the marketing authorization holder.

7.Instructions for use

Read the entire section 7 before using Skyrizi

Pre-filled pen of Skyrizi

Grey dark cap

(Do not remove

Green activator button Inspection window Needle until the time of

injection)

Grey retaining clips White needle cap

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 to inject Skyrizi
• Keep Skyrizi in its original packaging to protect the medicine from light until the time of use
• Take the carton out of the refrigerator and leave it at room temperature, away from direct sunlight, for30 to 90minutesbefore injection.
• 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 pen
• Wait to remove the grey dark cap until the time before 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 pen has fallen or been damaged
• if the packaging perforations are broken

Follow these steps every time you use Skyrizi