SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 360MG/2.4ML
2. INDICATIONS
2.1 Crohn’s Disease
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.
4. CONTRAINDICATIONS
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab or any of the excipients listed in section 15.2 (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ).
Clinically important active infections (e.g. active tuberculosis, see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
3. DOSAGE AND ADMINISTRATION
3.1 Recommended Dosage
Crohn’s Disease
The recommended dose is 600 mg administered by intravenous (IV) infusion at Week 0, Week 4, and Week 8, followed by 360 mg administered by subcutaneous (SC) injection at Week 12, and every 8 weeks thereafter.
3.2 Missed Dose
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
3.3 Dosing in Special Populations
Pediatrics
The safety and efficacy of SKYRIZI in pediatric patients with Crohn’s disease younger than 18 years of age have not yet been established.
Geriatric
No dose adjustment is required (see PHARMACOLOGIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ).
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 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 PHARMACOLOGIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ).
