HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use LuciDeucra safely and effectively. See full prescribing information for LuciDeucra.

INDICATIONS AND USAGE

LuciDeucra is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

Limitations of Use:

Not recommended for use in combination with other potent immunosuppressants.

DOSAGE AND ADMINISTRATION 

• For recommended evaluation prior to LuciDeucra initiation, see Full Prescribing Information. 

• Recommended dosage is 6 mg orally once daily, with or without food. 

DOSAGE FORMS AND STRENGTHS 

Tablets: 6 mg×30 tablets

CONTRAINDICATIONS 

Known hypersensitivity to deucravacitinib or any of the excipients in LuciDeucra. 

WARNINGS AND PRECAUTIONS 

• Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. Discontinue if a clinically significant hypersensitivity reaction occurs. 

• Infections: LuciDeucra may increase the risk of infection. Avoid use in patients with active or serious infection. If a serious infection develops, discontinue LuciDeucra until the infection resolves. 

• Tuberculosis: Evaluate for TB prior to initiating treatment with LuciDeucra. 

• Malignancy: Malignancies including lymphomas were observed in clinical trials with LuciDeucra (deucravacitinib) .

• Rhabdomyolysis and elevated CPK. 

• Laboratory Abnormalities: Periodically evaluate serum triglycerides. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease.

• Immunizations: Avoid use with live vaccines.

• 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 patients treated with a JAK inhibitor compared to those treated with TNF blockers in rheumatoid arthritis (RA) patients. LuciDeucra is not approved for use in RA. 

ADVERSE REACTIONS 

Most common adverse reactions (≥1%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. 

USE IN SPECIFIC POPULATIONS 

LuciDeucra is not recommended in patients with severe hepatic impairment (Child-Pugh C). 

Storage 

Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (59F and 86F) [see USP Controlled Room Temperature]. Protect from moisture.