Skyrizi 600 mg concentrado para solucion para perfusion

Prescribing Information for the Patient

Skyrizi 600 mg Concentrate for Solution for Infusion

risankizumab

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

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

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 and signs of your disease.

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 that your doctor or nurse keeps a copy of the batch number of Skyrizi.

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

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 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 1mmol of sodium (23mg) per vial; this is essentially “sodium-free”.

The treatment with Skyrizi will begin with an initial dose that your doctor or nurse will administer to you through an intravenous infusion in your arm.

Initial doses

Subsequently, you will receive Skyrizi through an injection under the skin. Please refer to the package insert for Skyrizi 90mg injectable solution in pre-filled syringe, and the package insert for 180 mg and 360 mg injectable solution in cartridge.

Maintenance doses

Missing a dose

If you forget to use Skyrizi, contact your doctor as soon as possible to reschedule the appointment.

Stopping treatment with Skyrizi

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

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 everyone 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 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)
• pruritus
• 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 the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Skyrizi 600mg concentrate for solution for infusion is administered in the hospital or healthcare center, and therefore patients do not have to conserve it or handle it.

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

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

Store in refrigerator (between 2°C and8 °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 for a prolonged period, the medication may be damaged.

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

Each vial is for single use.

Medications should not be disposed of through drains or in the trash. This will help protect the environment.

Composition of Skyrizi

• The active ingredient is risankizumab. Each vial contains 600 mg of risankizumab in 10 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 slightly yellow liquid contained in a vial. The liquid may contain small, transparent or white particles.

Each pack contains 1 vial.

Marketing authorization 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 request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:

http://www.ema.europa.eu.

The detailed and updated information about 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

Código QR to include

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

This information is intended solely for healthcare professionals

Trazabilidad

With the aim of improving the traceability of biological medicines, the name and batch number of the administered medicine must be clearly recorded.

Instrucciones de uso

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

1. It must be diluted before administration.

1. The infusion solution is prepared by diluting the concentrate in a infusion bag or a glass vial containing dextrose 5% 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. See the following table for dilution instructions depending on the patient's indication.

1. The solution in the vial and the dilutions must not be agitated.

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

1. The diluted solution must be infused 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 must not be administered concomitantly by the same intravenous route with other medicines.

Each vial is for single use and the disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

Conservación de la solución diluida

The solution has been shown to be chemically and physically stable in use for 20 hours between 2°C and 8°C (protected from light) or for up to 4 hours (cumulative time from the start of dilution to the start of infusion) at room temperature (protected from light).

Exposure to interior light is permitted during storage at room temperature and administration.

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