Baricent™ 2: Each film coated tablet contains Baricitinib INN 2 mg
Baricitinib is a selective and reversible inhibitor of Janus kinase JAK1 and JAK2. In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and > 400 nM, respectively. 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 modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.
Baricitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Limitation of Use: Use of Baricitinib in combination with other JAK inhibitors, biologic DMARDs, or with potent
immunosuppressants such as azathioprine and cyclosporine is not recommended.
The recommended dose of Baricitinib is 2 mg once daily. Baricitinib may be used as monotherapy or in combination with methotrexate or other 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.
Moderate Renal Impairment: Reduce dose to 1 mg once daily
Adverse reactions (greater than or equal to 1%) include: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
• Serious Infections: Avoid use of Baricitinib in patients with active, serious infection, including localized infections. If a seriousinfection develops, interrupt Baricitinib therapy until the infection is controlled. Do not give BARICITINIB to patients with activetuberculosis.
• Thrombosis: Use with caution in patients who may be at increased risk.
• Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.
• Laboratory Assessment: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes,and lipids.
• Vaccinations: Avoid use of Baricitinib with live vaccines.
Pregnancy & Lactation: There are no adequate and well-controlled studies in pregnant women. It is not known whether Baricitinib is excreted in human milk.
Pediatric Use: The safety and effectiveness of Baricitinib in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment: No dose adjustment is necessary in patients with mild or moderate hepatic impairment. The use of Baricitinib has not been studied in patients with severe hepatic impairment and is therefore not recommended.
Renal Impairment: Renal function was found to significantly affect Baricitinib exposure. The recommended dose of Baricitinib in patients with moderate renal impairment (estimated glomerular filtration rate (GFR) between 30 and 60 mL/min/1.73 m2) is 1 mg once daily. Baricitinib is not recommended for use in patients with severe renal impairment (estimated GFR of less than 30 mL/min/1.73 m2)
The recommended dose of Baricitinib in patients taking strong Organic Anion Transporter 3 (OAT3) inhibitors (e.g., probenecid) is 1 mg once daily.
Do not store above 30 0C. Keep away from light and out of the reach of children
Baricent™ 2 Container Pack: Each box contains 20 tablets.