Deucravacitinib is used to treat adults with moderate to severe plaque psoriasis who require systemic treatment or phototherapy. It is not advised to use Deucravacitinib together with other strong immunosuppressive medicines.

Deucravacitinib is a selective inhibitor of tyrosine kinase 2 (TYK2), which belongs to the Janus kinase (JAK) family. It binds to the regulatory region of TYK2 and stabilizes an inactive interaction between the regulatory and catalytic domains of the enzyme. This leads to allosteric inhibition of receptor-mediated TYK2 activation and reduces downstream signaling through Signal Transducers and Activators of Transcription (STATs), as demonstrated in cell-based studies. JAK family enzymes, including TYK2, operate as homo- or heterodimers within JAK-STAT signaling pathways. TYK2 can pair with JAK1 to regulate multiple cytokine pathways and also with JAK2 to transmit cellular signals in experimental models. However, the exact mechanism by which TYK2 inhibition produces clinical benefit in adults with moderate-to-severe plaque psoriasis is not yet fully understood.

Recommended Evaluations and Immunizations Prior to Treatment Initiation: Evaluate patients for active and latent tuberculosis (TB) infection prior to initiating treatment with Deucravacitinib. If positive, start treatment for TB prior to Deucravacitinib.

Recommended Dosage: The recommended dosage of Deucravacitinib is 6 mg taken orally once daily, with or without food. Do not crush, cut, or chew the tablets.

Pediatric Use: The safety and effectiveness in pediatric patients have not been established. Geriatric Use: No overall differences in effectiveness have been observed between patients 65 years of age and older and younger adult patients.

Recommended Dosage in Patients with Hepatic Impairment: Deucravacitinib is not recommended in patients with severe hepatic impairment (Child-Pugh C). No dosage adjustment is needed for patients with mild to moderate hepatic impairment.

Renal Impairment: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment or in patients with end stage renal disease (ESRD) on dialysis

Clinical studies showed no clinically meaningful changes in the pharmacokinetics of deucravacitinib when it was given together with cyclosporine (a dual Pgp/BCRP inhibitor), fluvoxamine (CYP1A2 inhibitor), ritonavir (CYP1A2 inducer), diflunisal (UGT1A9 inhibitor), pyrimethamine (OCT1 inhibitor), famotidine (H2 receptor antagonist), or rabeprazole (proton pump inhibitor). Similarly, deucravacitinib did not cause clinically significant pharmacokinetic changes in co-administered drugs such as rosuvastatin, methotrexate, mycophenolate mofetil (MMF), or oral contraceptives containing norethindrone acetate and ethinyl estradiol.

Deucravacitinib should not be used in patients who have previously experienced a hypersensitivity reaction to Deucravacitinib or to any of the ingredients (excipients) in the formulation.

The most frequently reported side effects of Deucravacitinib include upper respiratory tract infections such as the common cold, sore throat, and sinus infections, as well as cold sores (herpes simplex), canker sores affecting the inner lips, gums, tongue, or roof of the mouth, inflamed hair follicles (folliculitis), and acne. It may also cause serious allergic reactions, which can present as fainting, swelling of the face, eyelids, lips, mouth, tongue, or throat, difficulty breathing, tightness in the throat or chest, skin rash, or hives.

Available case report data on the use of Deucravacitinib during pregnancy are not sufficient to determine any drug-related risk of major birth defects, miscarriage, or other adverse outcomes for the mother or fetus. Animal reproductive studies did not show any harmful effects on embryo or fetal development. There is currently no information on whether Deucravacitinib is present in human breast milk, nor are there data on its effects on the breastfed infant or on milk production. The benefits of breastfeeding should be weighed against the mother’s clinical need for Deucravacitinib and any possible risks to the breastfed infant.

Hypersensitivity: Hypersensitivity reactions, including angioedema, have been reported. Discontinue Deucravacitinib if a clinically significant hypersensitivity reaction occurs.

Infections: Deucravacitinib may increase the risk of infections. It should not be used in patients with active or serious infections. If a serious infection develops during treatment, discontinue the drug until the infection resolves.

Tuberculosis: Patients should be evaluated for tuberculosis before starting treatment with Deucravacitinib.

Malignancy: Cases of malignancies, including lymphomas, have been observed in clinical trials of Deucravacitinib.

Laboratory Abnormalities: Serum triglyceride levels should be monitored periodically. Liver enzymes should be assessed at baseline and during treatment in patients with known or suspected liver disease.

Immunizations: Live vaccines should be avoided during treatment.

Potential Risks Related to JAK Inhibition: It is currently unknown whether TYK2 inhibition is associated with the same adverse effects seen with JAK inhibition. However, in patients with rheumatoid arthritis treated with JAK inhibitors compared to TNF blockers, higher rates of overall mortality (including sudden cardiovascular death), major cardiovascular events, thrombosis (including deep vein thrombosis and pulmonary embolism), and malignancies (excluding non-melanoma skin cancer) have been observed. Deucravacitinib is not approved for the treatment of rheumatoid arthritis.

Rhabdomyolysis and elevated CPK

Topical Antifungal preparations, Tyrosine Kinase Inhibitor

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.