SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML

AbbVie Biotechnology Ltd. (Bulk Production and Primary Packager) (PUERTO RICO)🇸🇬 Health Sciences Authority

Approval Date: Oct 1, 2021
Approval ID: a96437750dc7e4a9
Company: AbbVie Biotechnology Ltd. (Bulk Production and Primary Packager) (PUERTO RICO)
Type: Therapeutic

Approval Details

Approval Id: a96437750dc7e4a9
Drug Name: SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML
Product Name: SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/ML
Approval Number: SIN16339P
Approval Date: 2021-10-01
Registrant: ABBVIE PTE. LTD.
Licence Holder: ABBVIE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: 3. DOSAGE AND ADMINISTRATION 3.1 Recommended Dosage Plaque Psoriasis The recommended dose is 150 mg administered by 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 patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. Psoriatic Arthritis The recommended dose is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. SKYRIZI may be used as monotherapy or in combination with non-biologic DMARDs. Palmoplantar Pustulosis The recommended dose is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 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 patients with plaque psoriasis or psoriatic arthritis 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.).
Route Of Administration: SUBCUTANEOUS
Indication Info: 2. INDICATIONS 2.1 Plaque Psoriasis SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 2.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults who have an inadequate response or who have been intolerant to at least one prior disease-modifying antirheumatic drug (DMARD) therapy. 2.3 Palmoplantar Pustulosis SKYRIZI is indicated for the treatment of moderate to severe palmoplantar pustulosis in adults who do not adequately respond or are intolerant to conventional therapy.
Contraindications: 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).
Atc Code: L04AC18
Atc Item Name: risankizumab
Pharma Manufacturer Name: ABBVIE PTE. LTD.

Active Ingredients

Risankizumab

150mg

Risankizumab

150mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 1, 2021

Approval ID

a96437750dc7e4a9

Type

Therapeutic

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