Posology : מינונים

4.2    Posology and method of administration

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

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.

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 section 5.2).
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 section 5.2).

Paediatric population

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.

Overweight patients

No dose adjustment is required (see section 5.2).
Method of administration

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.