Barinib 4 mg (Tablet)

Indications

• Treatment of adult patients with moderate to severely active Rheumatoid Arthritis

Mode of Action

• Selective and reversible inhibitor of Janus kinase JAK1 and JAK2

Dosage & Administration

• Recommended dose of 2 mg once daily
• Can be used as monotherapy or in combination with Methotrexate or other Disease-modifying antirheumatic drugs (DMARDS)
• Orally administrable with or without food

Pediatric Use

• Safety and effectiveness not established

Geriatric Use

• Dose selection caution due to decreased renal function in elderly patients

Hepatic Impairment

• No dose adjustment necessary in patients with mild or moderate hepatic impairment

Renal Impairment

• Not recommended for use in patients with estimated GFR of less than 60 mL/min/I .73 m2

Interaction

• Increased exposure when co-administered with strong OAT3 inhibitors
• Not studied in combination with other JAK inhibitors or with biologic DMARDS

Contraindications

• Avoid in patients with hemoglobin less than 8 g/dL
• Avoid in patients with an Absolute Lymphocyte Count less than 500 cells/mm3
• Avoid in patients with an Absolute Neutrophil Count less than 1000 cells/mm3

Side Effects

• Commonly reported adverse drug reactions include increased LDL cholesterol, upper respiratory tract infections, and nausea

Pregnancy & Lactation

• Contraindicated during pregnancy
• No information available on the presence of the drug in human milk

Precautions & Warnings

• Avoid use in patients with an active, serious infection, including localized infections
• Should not be given to patients with active TB
• Consider risks and benefits prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC)
• Use with caution in patients at increased risk of thrombosis or gastrointestinal perforation

Overdose Effects

• Monitor for signs and symptoms of adverse reactions in case of overdose

Therapeutic Class

• Immunosuppressant

Storage Conditions

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

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