SOTYKTU FILM-COATED TABLETS 6 MG [SIN16939P]

Product Info

SOTYKTU FILM-COATED TABLETS 6 MG

[SIN16939P]

4.1 Therapeutic indications

SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

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.

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).