LuciDeucra

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.