SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 180MG/1.2ML [SIN17326P]

Product Info

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE WITH ON-BODY INJECTOR 180MG/1.2ML

[SIN17326P]

Indication

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.

2.2 Ulcerative Colitis

SKYRIZI is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy.

Dosing

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.

Ulcerative Colitis

The recommended dose is 1200 mg administered by intravenous (IV) infusion at Week 0, Week 4, and Week 8, followed by 180 mg or 360 mg administered by subcutaneous (SC) injection at Week 12, and every 8 weeks thereafter.

• A dose of 180 mg administered by subcutaneous injection is recommended for patients with adequate improvement in disease activity after induction

• A dose of 360 mg administered by SC injection is recommended for patients with inadequate improvement in disease activity after induction.

Consideration should be given to discontinuing treatment in patients who have shown no evidence of therapeutic benefit by Week 24.

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, or ulcerative colitis 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).

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information (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)