Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
SOTYKTU is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Treatment should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
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.
No dose adjustment is required in elderly patients aged 65 years and older (see section 5.2). Clinical experience in patients ≥75 years is very limited and deucravacitinib should be used with caution in this group of patients.
No dose adjustment is required in patients with renal impairment, including end stage renal disease (ESRD) patients on dialysis (see section 5.2).
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).
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.
For oral use.
Tablets can be taken with or without food. Tablets should be swallowed whole and should not be crushed, cut, or chewed.
Deucravacitinib has been administered in healthy subjects as single doses up to 40 mg (>6 times the recommended human dose of 6 mg/day) and in multiple doses up to 24 mg/day (12 mg twice daily) for 14 days without dose-limiting toxicity.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted immediately. Dialysis does not substantially clear deucravacitinib from systemic circulation (see section 5.2).
2 years.
This medicinal product does not require any special storage conditions.
Polyvinyl chloride/polychlorotrifluoroethylene (PVC/PCTFE) clear blister with push through aluminium foil containing 7 or 14 film-coated tablets per blister (calendar or non-calendar blisters).
Pack sizes: 7, 14, 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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