Skyrizi Dosage/Direction for Use

Skyrizi 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.
Posology: 150 mg: The recommended dose is 150 mg administered as a subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
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.
360 mg/600 mg: 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.
Missed dose: If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
Special populations: Elderly (aged 65 years and over): No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
There is limited information in subjects aged ≥65 years.
Renal or hepatic impairment: 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 Pharmacology: Pharmacokinetics under Actions).
Paediatric population: 150 mg: The safety and efficacy of risankizumab in children and adolescents aged 5 to 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.
360 mg/600 mg: The safety and efficacy of Skyrizi in children aged 0-17 years for the treatment of Crohn's disease have not yet been established. Currently available data are described in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on posology can be made.
Overweight patients: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: 150 mg/360 mg: 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, affected by psoriasis or damaged.
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.
600 mg: 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. For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.