듀크라바시티닙

is a tyrosine kinase 2 (TYK2) inhibitor indicated for: • the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other potent immunosuppressants. • the treatment of active psoriatic arthritis in adults. ( 1.2 ) 1.1 Plaque Psoriasis SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Limitations of Use : SOTYKTU is not recommended for use in combination with other potent immunosuppressants. 1.2 Psoriatic Arthritis SOTYKTU is indicated for the treatment of active psoriatic arthritis in adults.

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) ] . History of hypersensitivity reaction to deucravacitinib or any of the excipients in SOTYKTU. ( 4 , 5.1 )

• Hypersensitivity Reactions: 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 latent or active TB prior to initiating treatment with SOTYKTU. (5.3) • Malignancy: Malignancies including lymphomas were observed in clinical trials with SOTYKTU. Consider the benefits and risks prior to initiating or continuing SOTYKTU in patients with a malignancy. (5.4) • Rhabdomyolysis and Elevated CPK: Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected . (5.5) • Laboratory Abnormalities: Periodically evaluate serum triglycerides. Evaluate liver enzymes at baseline and during SOTYKTU treatment in patients with known or suspected liver disease. (5.6) • Immunizations: Avoid use of SOTYKTU with live vaccines. (5.7) • Potential Risks Related to JAK Inhibition: It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of JAK inhibition. Higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in …

8.1 Pregnancy Risk Summary Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development were observed with oral administration of deucravacitinib to rats and rabbits during organogenesis at doses that were at least 72 times the maximum recommended human dose (MRHD) of 6 mg once daily (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the …