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 subsequent subcutaneous dosing regimen, see section 4.2 of the Skyrizi 360 mg solution for injection in cartridge and Skyrizi 90 mg pre-filled syringe 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 subsequent subcutaneous dosing regimen, see section 4.2 of the Skyrizi 180 mg and 360 mg solution for injection in cartridge 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).
For intravenous infusion.
Skyrizi concentrate for solution for infusion is for intravenous use only. The 600 mg dose should be administered over at least one hour, and the 1 200 mg dose should be administered over at least two hours. For instructions on dilution of the medicinal product before administration, see section 6.6.
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.
Diluted solution for intravenous infusion:
Chemical and physical in-use stability has been demonstrated for 20 hours at 2°C to 8°C (protected from light) or up to 4 hours (cumulative time from start of dilution to start of infusion) at room temperature (protected from light). Exposure to indoor light is acceptable during room temperature storage and administration.
From a microbiological point of view, the prepared infusion should be used immediately. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and should not be longer than 20 hours at 2°C to 8°C.
Do not freeze.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
10.0 mL concentrate solution for infusion in a glass vial closed with a coated bromobutyl rubber stopper.
Skyrizi is available in packs containing 1 vial pack.
The solutions should be visually inspected for particulate matter or discoloration prior to administration. The solution should be colourless to slightly yellow and clear to slightly opalescent. The liquid may contain tiny white or clear particles. The medicinal product and its dilutions should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
This medicinal product should be prepared by a healthcare professional using aseptic technique. It must be diluted before administration.
The solution for infusion is prepared by dilution of the concentrate into an intravenous infusion bag or glass bottle containing 5% dextrose in water (D5W) or sodium chloride 9 mg/mL (0.9%) solution for infusion to a final concentration of approximately 1.2 mg/mL to 6 mg/mL. Refer to table below for dilution instructions based on patient’s indication.
| Indication | Intravenous induction dose | Number of 600 mg/10 mL vials | Total volume of 5% dextrose or sodium chloride 9 mg/mL (0.9%) solution for infusion |
|---|---|---|---|
| Crohn’s disease | 600 mg | 1 | 100 mL, or 250 mL, or 500 mL |
| Ulcerative colitis | 1 200 mg | 2 | 250 mL, or 500 mL |
Prior to the start of the intravenous infusion, the content of the intravenous infusion bag or glass bottle should be at room temperature.
Infuse the diluted solution over a period of at least one hour for the 600 mg dose; at least two hours for the 1 200 mg dose.
The solution in the vial and the dilutions should not be shaken.
Each vial 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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