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 adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
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 600 mg administered by intravenous infusion at week 0, week 4, and week 8, followed by 360 mg administered by subcutaneous injection at week 12, and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24.
For the posology of the initial intravenous dosing regimen, see section 4.2 of the Skyrizi 600 mg concentrate for solution for infusion Summary of Product Characteristics.
The recommended induction dose is 1 200 mg administered by intravenous infusion at week 0, week 4, and week 8. Starting at week 12 and every 8 weeks thereafter, the recommended maintenance dose is based on individual patient presentation:
Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by week 24.
For the posology of the initial intravenous dosing regimen, see section 4.2 of the Skyrizi 600 mg concentrate for solution for infusion Summary of Product Characteristics.
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 Skyrizi. 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 Skyrizi in children aged 0-17 years for the treatment of Crohn’s disease and ulcerative colitis have not yet been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on posology can be made.
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. Skyrizi should not be injected into areas where the skin is tender, bruised, erythematous, indurated or damaged.
Skyrizi 180 mg and 360 mg solution for injection in cartridge:
Patients may self-inject Skyrizi after training in subcutaneous injection technique with the on-body injector. Patients should be instructed to read the ‘Instructions for use’ provided in the package leaflet before administration.
Skyrizi 90 mg solution for injection in pre-filled syringe:
This medicinal product should be administered by a healthcare professional.
Four pre-filled syringes should be injected to administer the full 360 mg dose. The four injections should be administered at different anatomic locations (see administration instructions provided with the package leaflet).
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.
The cartridge may be stored out of the refrigerator (up to a maximum of 25°C) for up to 24 hours.
Keep the cartridge or pre-filled syringes in the outer carton in order to protect from light.
Skyrizi 360 mg solution for injection in cartridge:
A 360 mg solution in a single use cartridge made with cyclic olefin resin with coated chlorobutyl rubber septum and coated chlorobutyl rubber piston as product-contact materials, and a resin cap. The cartridge assembly is co-packed with an on-body injector (administration device). The fluid path within the on-body injector contains polyvinyl chloride tubing and a stainless steel 29-gauge needle. The on-body injector contains silver oxide-zinc batteries and an adhesive skin patch made from polyester with an acrylic adhesive. The administration device is designed for use with the provided 360 mg cartridge.
Skyrizi 360 mg is available in packs containing 1 cartridge and 1 on-body injector.
Skyrizi 180 mg solution for injection in cartridge:
A 180 mg solution in a single use cartridge made with cyclic olefin resin with coated chlorobutyl rubber septum and coated chlorobutyl rubber piston as product-contact materials, and a resin cap. The cartridge assembly is co-packed with an on-body injector (administration device). The fluid path within the on-body injector contains polyvinyl chloride tubing and a stainless steel 29-gauge needle. The on-body injector contains silver oxide-zinc batteries and an adhesive skin patch made from polyester with an acrylic adhesive. The administration device is designed for use with the provided 180 mg cartridge.
Skyrizi 180 mg is available in packs containing 1 cartridge and 1 on-body injector.
Skyrizi 90 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 90 mg is available in packs containing 4 pre-filled syringes.
Not all presentations may be marketed.
Skyrizi 180 mg and 360 mg solution for injection in cartridge:
Before injecting, the carton should be removed from the refrigerator and allowed to reach room temperature, out of direct sunlight, for 45 to 90 minutes without removing the cartridge from the carton.
Prior to use, a visual inspection of the cartridge is recommended. The solution is free from foreign particles and practically free from product-related particles. Skyrizi should not be used if the solution is cloudy or discoloured, or contains large particles. Do not shake the cartridge.
The solution should be colourless to yellow and clear to slightly opalescent.
Skyrizi 90 mg solution for injection in pre-filled syringe:
Before injecting, the carton should be removed from the refrigerator and allow to reach room temperature out of direct sunlight, for 15 to 30 minutes without removing the pre-filled syringes from the carton.
Prior to use, a visual inspection of each 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 syringe.
The solution should be colourless to slightly yellow and clear to slightly opalescent.
Comprehensive instructions for use are provided in the package leaflet.
Each on-body injector with cartridge and pre-filled syringe are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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