SOTYKTU

Following oral administration, deucravacitinib plasma C max and AUC increased proportionally over a dose range from 3 mg to 36 mg (0.5 to 6 times the approved recommended dosage) in healthy subjects. The accumulation of deucravacitinib was <1.4-fold following once daily dosing in healthy subjects. The PK of deucravacitinib and its active metabolite, BMT‑153261, were comparable between healthy subjects and subjects with psoriasis. The steady state C max and AUC 24 of deucravacitinib following adm...

14.1 Plaque Psoriasis The efficacy and safety of SOTYKTU 6 mg once daily were assessed in two multicenter, randomized, double-blind, placebo- and active-controlled clinical trials, PSO-1 (NCT03624127) and PSO-2 (NCT03611751) which enrolled subjects 18 years of age and older with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Subjects had a body surface area (BSA) involvement of ≥ 10%, a Psoriasis Area and Severity Index (PASI) score ≥ 12, and a static Physician’s Global Assessment (sPGA) ≥ 3 (moderate or severe). In PSO-1 and PSO-2, efficacy was ass...

The following adverse reactions are discussed in greater detail in other sections of labeling:

• Infections [see Warnings and Precautions (5.2) ]
• Malignancy including lymphomas [see Warnings and Precautions (5.4) ]
• Laboratory Abnormalities [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥ 1%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ...

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU [see Warnings and Precautions (5.1) ] . Known hypersensitivity to deucravacitinib or any of the excipients in SOTYKTU. ( 4 , 5.1 )

• Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs. (5.1)
• Infections: SOTYKTU may increase the risk of infection. Avoid use in patients with active or serious infection. If a serious infection develops, discontinue SOTYKTU until the infection resolves. (5.2)
• Tuberculosis: Evaluate for TB prior to initiating treatment with SOTYKTU. (5.3)
• Malignancy: Malignancies including lymphomas we...