SKYRIZI 600 mg CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Skyrizi 600 mg Concentrate for Solution for Infusion

risankizumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What is Skyrizi and what is it used for
2. What you need to know before you use Skyrizi
3. How to use Skyrizi
4. Possible side effects
5. Storage of Skyrizi
6. Contents of the pack and other information

1. What is Skyrizi and what is it 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 disease of the digestive system. If you have active Crohn's disease, you may first be given other medicines. If these medicines do not work well enough, you will be given Skyrizi to treat your Crohn's disease.

Ulcerative Colitis

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

Skyrizi reduces inflammation and can help reduce the signs and symptoms of your disease.

2. What you need to know before you use Skyrizi

Do not use Skyrizi

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

Warnings and precautions

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

• if you have a current infection or if you have an infection that keeps coming back.
• if you have tuberculosis (TB).
• if you have recently received or are scheduled to receive a vaccine. Certain vaccines should not be given during treatment with Skyrizi.

It is important that your doctor or nurse keeps a record of the batch number of Skyrizi.

Each time you receive a new pack of Skyrizi, your doctor or nurse should note the date and batch number (which appears on the pack after "Lot").

Allergic Reactions

Talk to your doctor or seek medical attention right away 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
• severe itching of the skin, with a red rash or hives

Children and Adolescents

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

Other medicines and Skyrizi

Tell your doctor, pharmacist, or nurse:

• if you are using, have recently used, or might use any other medicines.
• if you have been vaccinated recently or are scheduled to be vaccinated. Certain vaccines should not be given during treatment with Skyrizi.

If in doubt, consult your doctor, pharmacist, or nurse before using Skyrizi and during 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. You must do this because it is not known how this medicine will affect your baby.

If you are a woman who can become pregnant, you must use contraception while being treated 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

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

Skyrizi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

3. How to use Skyrizi

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

Initial Doses

Afterwards, you will receive Skyrizi through an injection under the skin. Refer to the package leaflet of Skyrizi 90 mg solution for injection in pre-filled syringe, and the package leaflet of 180 mg and 360 mg solution for injection in cartridge.

Maintenance Doses

If you miss a dose of Skyrizi

If you miss or skip an appointment to receive any of the doses, contact your doctor as soon as you remember to reschedule the appointment.

If you stop treatment with Skyrizi

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Talk to your doctor or seek medical attention right away if you have any symptoms of a serious infection, such as:

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

Your doctor will decide if you can continue using Skyrizi.

Other side effects

Tell your doctor, pharmacist, or nurse if you notice any of the following side 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
• 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 of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Skyrizi

Skyrizi 600 mg concentrate for solution for infusion is administered in a hospital or healthcare setting, and therefore, patients do not need to store or handle it.

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

Do not use this medicine after the expiry date which is stated on the label of the vial and on the outer carton after EXP.

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

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

Do not shake the Skyrizi vial. If shaken vigorously and for a long time, the medicine may be damaged.

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

Each vial is for single use only.

Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

What Skyrizi contains

• The active substance is risankizumab. Each vial contains 600 mg of risankizumab in 10 ml of solution.
• The other ingredients are sodium acetate trihydrate, acetic acid, trehalose dihydrate, polysorbate 20, and water for injections.

Appearance and packaging

Skyrizi is a clear, colorless to slightly yellowish liquid in a vial. The liquid may contain tiny, transparent or white particles.

Each pack contains 1 vial.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie S.r.l.

04011 Campoverde di Aprilia

(Latina)

Italy

or

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

You can get more information about this medicine from your local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:

Other sources of information

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

Detailed and up-to-date information on this product is available at the following website: www.skyrizi.eu

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This information is intended only for healthcare professionals

Traceability

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Instructions for use

1. This medicine should be prepared by a healthcare professional using aseptic technique.

1. It should be diluted before administration.

1. The infusion solution is prepared by diluting the concentrate in an infusion bag or a glass vial containing 5% glucose in water (D5W) or a 9 mg/ml sodium chloride (0.9%) infusion solution to a final concentration of approximately 1.2 mg/ml to 6 mg/ml. Refer to the table below for dilution instructions based on the patient's indication.

1. The solution in the vial and the dilutions should not be shaken.

1. Before starting the intravenous infusion, the contents of the infusion bag or glass vial should be at room temperature.

1. Infuse the diluted solution over a period of at least one hour for the 600 mg dose and at least two hours for the 1,200 mg dose.

1. The solution from the vial should not be administered concomitantly via the same intravenous line as other medicines.

Each vial is for single use only, and the disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

Storage of the diluted solution

Chemical and physical stability in-use has been demonstrated for 20 hours between 2°C and 8°C (protected from light) or up to 4 hours (accumulated time from the start of dilution to the start of infusion) at room temperature (protected from light). Exposure to indoor light is allowed during storage at room temperature and administration.

From a microbiological point of view, the prepared infusion should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and should not exceed 20 hours at a temperature between 2°C and 8°C. Do not freeze.