Baricitinib tablets are prescribed for adult patients with moderate to severely active Rheumatoid Arthritis who have not responded adequately to one or more tumor necrosis factor (TNF) inhibitor therapies.

Limitation of Use: Baricitinib should not be used in combination with other JAK inhibitors, biologic DMARDs, or strong immunosuppressants such as Azathioprine or Cyclosporine.

Baricitinib is a selective, reversible inhibitor of Janus kinase (JAK) 1 and JAK2. JAKs are enzymes that transmit signals from cell surface receptors for various cytokines and growth factors involved in blood cell formation, inflammation, and immune function. Inside the cell, JAKs phosphorylate and activate STAT proteins (signal transducers and activators of transcription), which in turn trigger gene expression. Baricitinib modulates these pathways by partially inhibiting JAK1 and JAK2, reducing STAT phosphorylation and activation.

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: Concomitant use of Baricitinib with strong OAT3 inhibitors (e.g., probenecid) may increase Baricitinib plasma concentrations.

Other JAK Inhibitors or Biologic DMARDs: Baricitinib has not been studied in combination with other JAK inhibitors or biologic DMARDs; therefore, combined use is not recommended.

• Anemia: Do not initiate or continue Baricitinib therapy in patients with hemoglobin levels below 8 g/dL.
• Lymphopenia: Avoid starting or interrupt treatment in patients with an Absolute Lymphocyte Count (ALC) under 500 cells/mm³.
• Neutropenia: Avoid starting or discontinue treatment in patients with an Absolute Neutrophil Count (ANC) below 1000 cells/mm³.

The most frequently reported adverse drug reactions (ADRs), occurring in at least 2% of patients receiving Baricitinib either as monotherapy or in combination with conventional synthetic DMARDs, include elevated LDL cholesterol (33.6%), upper respiratory tract infections (14.7%), and nausea (2.8%).

Baricitinib is contraindicated during pregnancy. There are no available data regarding the presence of Baricitinib in human breast milk.

• Serious Infections: Avoid using Baricitinib in patients with active, serious infections, including localized infections.
• Tuberculosis: Do not administer Baricitinib to patients with active tuberculosis (TB).
• Malignancy and Lymphoproliferative Disorders: Carefully evaluate the risks and benefits before initiating Baricitinib in patients with a current or past history of malignancy (except successfully treated non-melanoma skin cancer), and reassess treatment if a malignancy develops during therapy.
• Thrombosis: Use Baricitinib cautiously in patients who may have an increased risk of thrombotic events.
• Gastrointestinal Perforation: Exercise caution in patients at higher risk for gastrointestinal perforation.
• Prescription Status: To be dispensed only on the prescription of a registered physician.

In the event of an overdose, patients should be closely monitored for any signs and symptoms of adverse reactions. If adverse reactions occur, appropriate symptomatic and supportive treatment should be provided.

Immunosuppressant

Store at a temperature not exceeding 30°C. Protect from light and moisture. Keep out of the reach of children.