Baricit Tablet

Baricit tablet is indicated for the treatment of adult patients with moderate to severely active Rheumatoid Arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Limitation of Use: Use of Baricit in combination with other JAK inhibitors, biologic DMARDs or with potent immunosuppressants such as Azathioprine and cyclosporine is not recommended.

Baricitinib is a selective and reversible inhibitor of Janus kinase JAK1 and JAK2. Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function. Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell. Baricitinib modulate these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.

Adult dose: The recommended dose of Baricitinib is 2 mg once daily. It may be used as monotherapy or in combination with Methotrexate or other Disease-modifying antirheumatic drugs (DMARDS). Baricitinib can be given orally with or without food.

Pediatric Use: The safety and effectiveness of Baricitinib in pediatric patients have not been established.

Geriatric Use: Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection.

Hepatic Impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment.

Renal impairment: Baricitinib is not recommended for use in patients with estimated GFR of less than 60 mL/min/I .73 m2.

Strong OAT3 Inhibitors: Baricit exposure is increased when it is co-administered with strong OAT3 inhibitors (such as probenecid).

Other JAK Inhibitors or Biologic DMARDs: Baricit has not been studied in combination with other JAK inhibitors or with biologic DMARDS.

• Anemia: Avoid initiation or interrupt Baricitinib in patients with hemoglobin less than 8 g/dL.
• Lymphopenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Lymphocyte Count less than 500 cells/mm³.
• Neutropenia: Avoid initiation or interrupt Baricitinib in patients with an Absolute Neutrophil Count less than 1000 cells/mm³.

The most commonly reported adverse drug reactions (ADRs) occurring in 2% of patients treated with Baricit monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6%), upper respiratory tract infections (14.7%) and nausea (2.8%).

Baricitinib is contraindicated during pregnancy. No information is available on the presence of Baricitinib in human milk.

• Serious Infections: Avoid use of Baricit in patients with an active, serious infection, including localized infections.
• Tuberculosis: Baricit should not be given to patients with active TB.
• Malignancy and Lymphoproliferative Disorders: Consider the risks and benefits of Baricit treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Baricit in patients who develop a malignancy.
• Thrombosis: Baricit should be used with caution in patients who may be at increased risk of thrombosis.
• Gastrointestinal Perforations: Baricit should be used with caution in patients who may be at increased risk for gastrointestinal perforation.
• To be dispensed only by the prescription of a registered physician.

In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.

Immunosuppressant

Store at or below 30°C temperature. Keep away from light and wet place. Keep out of reach of children.