Sotyktu

Treatment should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which SOTYKTU is indicated. 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. 2). Clinical experience in patients ≥ 75 years is very limited and deucravacitinib should be used with caution in this group of patients. 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.

2). 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.

1% in psoriatic arthritis studies). Overall, the safety profile observed in psoriatic arthritis patients treated with deucravacitinib was consistent with the safety profile observed in patients with plaque psoriasis. The longer-term safety profile of deucravacitinib was similar and consistent with previous experience.

Tabulated list of adverse reactions Adverse reactions for deucravacitinib from clinical studies are listed (see Table 1) by MedDRA System Organ Class and are based on the following conventions: very common (≥ 1/10); 6 common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (cannot be estimated from the available data).

Table 1:

List of adverse reactions System Organ Class Frequency Adverse reaction Infections and infestations Very common Upper respiratory infectionsa Common Herpes simplex infectionsb Uncommon Pneumonia Herpes zoster Bronchitis Gastrointestinal disorders Common Oral ulcersc Skin and subcutaneous tissue disorders Common Acneiform rashd Folliculitis Investigations Common Blood creatine phosphokinase increased a Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, pharyngitis, sinusitis, acute sinusitis, rhinitis, tonsillitis, peritonsillar abscess, laryngitis, tracheitis, pharyngotonsillitis, and rhinotracheitis.

b Herpes simplex infections include oral herpes, herpes simplex, genital herpes, herpes ophthalmic, and herpes viral infection. c Oral ulcers include aphthous ulcer, mouth ulceration, tongue ulceration, and stomatitis. d Acneiform rash includes acne, dermatitis acneiform, rash, rosacea, pustule, rash pustular, rash papular, and papule.

7 events per 100 person-years) during the first 16 weeks. The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of deucravacitinib. 6 events per 100 person-years). 4 events per 100 person-years).

8). 3). Caution should be exercised when considering the use of deucravacitinib in patients with a chronic infection or a history of recurrent infection. Patients treated with deucravacitinib should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.

If a patient develops a clinically important infection or is not responding to standard therapy, the patient should be monitored carefully and deucravacitinib should not be given until the infection resolves. Pre-treatment evaluation for tuberculosis Prior to initiating treatment with deucravacitinib, patients should be evaluated for tuberculosis (TB) infection.

3). Treatment of latent TB should be initiated prior to administering deucravacitinib. Anti-TB therapy should be considered prior to initiation of deucravacitinib in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Patients receiving deucravacitinib should be monitored for signs and symptoms of active TB. 4 Malignancies Malignancies, including lymphomas and non-melanoma skin cancer (NMSC), were observed in clinical studies with deucravacitinib.

It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the adverse reactions of Janus Kinase (JAK) inhibition. In a large randomised active controlled study of a JAK inhibitor in rheumatoid arthritis (RA) patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma and NMSC, was observed with a JAK inhibitor compared to tumour necrosis factor (TNF) inhibitors.

Limited clinical data are available to assess the potential relationship of exposure to deucravacitinib and the development of malignancies. Long-term safety evaluations are ongoing. The risks and benefits of deucravacitinib treatment should be considered prior to initiating patients.

1. g. 4).