- Approval Id
- 8edad5b9fd146899
- Drug Name
- SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.83ML
- Product Name
- SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.83ML
- Approval Number
- SIN15972P
- Approval Date
- 2020-07-06
- Registrant
- ABBVIE PTE. LTD.
- Licence Holder
- ABBVIE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>3. DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>3.1 Recommended Dosage</strong></p>
<p><u>Plaque Psoriasis</u></p>
<p>The recommended dose is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.</p>
<p>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.</p>
<p><u>Psoriatic Arthritis</u></p>
<p>The recommended dose is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.</p>
<p>SKYRIZI may be used as monotherapy or in combination with non-biologic DMARDs.</p>
<p><strong>3.2 Missed Dose</strong></p>
<p>If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.</p>
<p><strong>3.3 Dosing in Special Populations</strong></p>
<p><u>Pediatrics</u></p>
<p>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.</p>
<p><u>Geriatric</u></p>
<p>No dose adjustment is required <em>(see</em> <strong>PHARMACOLOGIC PROPERTIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
<p>There is limited information in subjects aged ≥ 65 years.</p>
<p><u>Renal or Hepatic Impairment</u></p>
<p>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 <em>(see</em> <strong>PHARMACOLOGIC PROPERTIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- <p><strong>2. INDICATIONS</strong></p>
<p><strong>2.1 Plaque Psoriasis</strong></p>
<p>SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.</p>
<p><strong>2.2 Psoriatic Arthritis</strong></p>
<p>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.</p>
- Contraindications
- <p><strong>4. CONTRAINDICATIONS</strong></p>
<p>SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab or any of the excipients listed in section 15.2 <em>(see</em> <strong>WARNINGS AND PRECAUTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>).</em></p>
<p>Clinically important active infections (e.g. active tuberculosis, see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- L04AC18
- Atc Item Name
- risankizumab
- Pharma Manufacturer Name
- ABBVIE PTE. LTD.
