- Approval Id
- c5f02d15159c8a14
- Drug Name
- SOTYKTU FILM-COATED TABLETS 6 MG
- Product Name
- SOTYKTU FILM-COATED TABLETS 6 MG
- Approval Number
- SIN16939P
- Approval Date
- 2024-02-04
- Registrant
- BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
- Licence Holder
- BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Treatment should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.</p>
<p><u>Posology</u></p>
<p>The recommended dose is 6 mg taken orally once daily.</p>
<p>If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment discontinuation should be considered. The patient's response to treatment should be evaluated on a regular basis.</p>
<p><u>Special populations</u></p>
<p><em>Elderly</em><br>
No dose adjustment is required in elderly patients aged 65 years and older (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Clinical experience in patients ≥ 75 years is very limited and deucravacitinib should be used with caution in this group of patients.</p>
<p><em>Renal impairment</em><br>
No dose adjustment is required in patients with renal impairment, including end stage renal disease (ESRD) patients on dialysis (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Hepatic impairment</em><br>
No dose adjustment is required in patients with mild or moderate hepatic impairment. Deucravacitinib is not recommended to be used in patients with severe hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of deucravacitinib in children and adolescents below the age of 18 years have not yet been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>For oral use.</p>
<p>Tablets can be taken with or without food. Tablets should be swallowed whole and should not be crushed, cut, or chewed.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.<br>
Clinically important active infections (e.g. active tuberculosis, see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- L04AF07
- Atc Item Name
- deucravacitinib
- Pharma Manufacturer Name
- BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
