SOTYKTU FILM-COATED TABLETS 6 MG [SIN16939P]
Active ingredients: DEUCRAVACITINIB
Last updated on 9 October 2026
Product Info
SOTYKTU FILM-COATED TABLETS 6 MG
[SIN16939P]
Product information
Active Ingredient and Strength | DEUCRAVACITINIB - 6 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | HOVIONE FARMACIENCIA S.A. - PORTUGAL |
Registration Number | SIN16939P |
Licence Holder | BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L04AF07 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Dosing
4.2 Posology and method of administration
Treatment should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Posology
The recommended dose is 6 mg taken orally once daily.
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.
Special populations
Elderly
No dose adjustment is required in elderly patients aged 65 years and older (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Clinical experience in patients ≥ 75 years is very limited and deucravacitinib should be used with caution in this group of patients.
Renal impairment
No dose adjustment is required in patients with renal impairment, including end stage renal disease (ESRD) patients on dialysis (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic impairment
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
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.
Method of administration
For oral use.
Tablets can be taken with or without food. Tablets should be swallowed whole and should not be crushed, cut, or chewed.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – 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 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).