Active Ingredient and Strength	RISANKIZUMAB - 150 MG/ML
Dosage Form	INJECTION, SOLUTION
Manufacturer and Country	ABBVIE BIOTECHNOLOGY LTD. (BULK PRODUCTION AND PRIMARY PACKAGER) - PUERTO RICO
Registration Number	SIN16338P
Licence Holder	ABBVIE PTE. LTD.
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	L04AC18

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.

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.).

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).