Regulatory Information
ABBVIE PTE. LTD.
ABBVIE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
INFUSION, SOLUTION CONCENTRATE
**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_ _)_.
INTRAVENOUS
Medical Information
**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_)
L04AC18
risankizumab
Manufacturer Information
ABBVIE PTE. LTD.
Patheon Italia S.P.A. (Bulk Production and Primary Packager)