Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Skyrizi is indicated.
The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter (either as two 75 mg pre-filled syringe injections or one 150 mg pre-filled pen or pre-filled syringe injection).
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some plaque psoriasis patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
No dose adjustment is required (see section 5.2).
There is limited information in subjects aged ≥65 years.
No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of risankizumab. These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2).
The safety and efficacy of risankizumab in children and adolescents aged 5 to less than 18 years have not been established. No data are available.
There is no relevant use of risankizumab in children aged below 6 years for the indication of moderate to severe plaque psoriasis or in children aged below 5 years for the indication of psoriatic arthritis.
No dose adjustment is required (see section 5.2).
Skyrizi is administered by subcutaneous injection.
The injection should be administered in the thigh or abdomen. Patients should not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
Patients may self-inject Skyrizi after training in subcutaneous injection technique. Patients should be instructed to read the ‘Instructions for use’ provided in the package leaflet before administration.
Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.
Skyrizi 75 mg solution for injection in pre-filled syringe:
Two pre-filled syringes should be injected for the full 150 mg dose. The two injections should be administered at different anatomic locations.
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
2 years.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled pen or the pre-filled syringe(s) in the outer carton in order to protect from light.
Skyrizi 150 mg pre-filled pen or pre-filled syringe may be stored out of the refrigerator (up to a maximum of 25°C) for up to 24 hours in the original carton to protect from light.
Skyrizi 150 mg solution for injection in pre-filled pen:
Pre-filled glass syringe assembled in a pre-filled pen with an automatic needle sleeve.
Skyrizi 150 mg solution for injection in pre-filled syringe:
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Skyrizi 150 mg is available in packs containing 1 pre-filled pen or 1 pre-filled syringe.
Skyrizi 75 mg solution for injection in pre-filled syringe:
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Skyrizi 75 mg is available in packs containing 2 pre-filled syringes and 2 alcohol pads.
Not all presentations may be marketed.
Skyrizi 150 mg solution for injection in pre-filled pen:
Before injecting, patients should remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (30 to 90 minutes) without removing the pre-filled pen from the carton.
The solution should be colourless to yellow and clear to slightly opalescent.
Skyrizi 150 mg solution for injection in pre-filled syringe:
Before injecting, patients may remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringe from the carton.
The solution should be colourless to yellow and clear to slightly opalescent.
Skyrizi 75 mg solution for injection in pre-filled syringe:
Before injecting, patients may remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringes from the carton.
The solution should be colourless to slightly yellow and clear to slightly opalescent.
Two pre-filled syringes should be injected for the full 150 mg dose.
Prior to use, a visual inspection of each pre-filled pen or pre-filled syringe is recommended. The solution may contain a few translucent to white product-related particles. Skyrizi should not be used if the solution is cloudy or discoloured, or contains large particles. Do not shake the pre-filled pen or pre-filled syringe.
Comprehensive instructions for use are provided in the package leaflet.
Each pre-filled pen or pre-filled syringe is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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