Cravacin Tablet

Cravacin is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Cravacin is not recommended for use in combination with other potent immunosuppressants.

Deucravacitinib is an inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Deucravacitinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. JAK kinases, including TYK2, function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.

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 Trials: No clinically significant differences in the pharmacokinetics of Cravacin were observed when co-administered with the following drugs: Cyclosporine (dual Pgp/BCRP inhibitor), fluvoxamine (CYP1A2 inhibitor), ritonavir (CYP1A2 inducer), diflunisal (UGT 1A9 inhibitor), pyrimethamine (OCT1 inhibitor), famotidine (H2 receptor antagonist), or rabeprazole (proton pump inhibitor). No clinically significant differences in the pharmacokinetics of the following drugs were observed when co-administered with Cravacin: Rosuvastatin, methotrexate, mycophenolate mofetil (MMF) and oral contraceptives (norethindrone acetate and ethinyl estradiol).

Deucravacitinib is contraindicated in patients with a history of hypersensitivity reaction to Deucravacitinib or to any of the excipients of this preparation.

The most common side effect of Cravacin include common cold, sore throat, and sinus infection (upper respiratory infections), cold sores (herpes simplex), sores on inner lips, gums, tongue, or roof of the mouth (canker sores), inflamed hair pores (folliculitis), acne. lt may cause serious allergic reactions including feeling faint or swelling in the face, eyelids, lips, mouth, tongue, or throat, trouble breathing or throat tightness or chest tightness or skin rash, hives etc.

Available data from case reports on Deucravacitinib use during pregnancy are insufficient to evaluate a drug-associated risk oi major birth defects, miscarriage. or adverse maternal or fetal outcomes. No effect on embryo-fetal development were seen in animal reproductive studies. There are no data on the presence of Deucravacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Deucravacitinib and any potential adverse effects on the breastfed infant from Deucravacitinib.

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

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

Tuberculosis: Evaluate for TB prior to initiating treatment with Cravacin.

Malignancy: Malignancies including lymphomas were observed in clinical trials with Cravacin.

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. This is not approved for use in RA.

Rhabdomyolysis and elevated CPK.

Topical Antifungal preparations, Tyrosine Kinase Inhibitor

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.