Barixen

• Approved Indications:
• Treatment of moderate to severe rheumatoid arthritis (RA) in adults, especially those with inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
• Treatment of active psoriatic arthritis (PsA) in adults.
• Treatment of moderate to severe atopic dermatitis in adults and adolescents (in select regions).
• Emergency use authorization or approved indication for hospitalized COVID-19 patients requiring supplemental oxygen or mechanical ventilation, in combination with antiviral therapy.
• Off-label Uses:
• Investigational use in autoimmune disorders such as alopecia areata.

• Route: Oral (tablet).
• Rheumatoid Arthritis:
• Initial dose: 2 mg once daily.
• May increase to 4 mg once daily in patients with inadequate response and low risk of adverse events.
• Psoriatic Arthritis and Atopic Dermatitis:
• Generally, 2 mg once daily; dose adjustment based on clinical response.
• COVID-19:
• 4 mg once daily for up to 14 days or until hospital discharge.
• Special Populations:
• Renal impairment:
• Moderate (eGFR 30–60 mL/min/1.73 m²): reduce dose to 2 mg once daily.
• Severe (eGFR <30 mL/min/1.73 m²): not recommended.
• Hepatic impairment:
• Mild to moderate: no adjustment needed.
• Severe: not recommended.
• Elderly: No specific adjustment; monitor for adverse effects.

Baricitinib selectively and reversibly inhibits Janus kinase (JAK) 1 and 2 enzymes. These kinases mediate intracellular signaling for multiple cytokines involved in inflammation and immune function via the JAK-STAT pathway. Inhibition reduces cytokine signaling, thereby decreasing inflammation and immune system overactivation, resulting in symptom relief in autoimmune and inflammatory diseases.

• Absorption: Rapid, with peak plasma concentration within 1 hour.
• Bioavailability: Approximately 79%.
• Distribution: Volume of distribution ~76 L; ~50% plasma protein bound.
• Metabolism: Minimal hepatic metabolism (~10%) mainly via CYP3A4.
• Elimination half-life: About 12.5 hours.
• Excretion: Primarily renal (~75% unchanged), remainder via feces.

• Pregnancy: Insufficient human data; animal studies suggest potential fetal risk at high doses. Use only if benefits justify potential risks.
• Lactation: Unknown if excreted in human milk; breastfeeding not recommended during treatment.

• Janus kinase (JAK) inhibitor
• Immunomodulatory agent

• Hypersensitivity to baricitinib or formulation components.
• Active serious infections including tuberculosis.
• Severe hepatic impairment.
• Severe neutropenia, lymphopenia, or anemia.

• Increased risk of serious infections.
• Potential for malignancies and thrombosis (DVT, PE).
• Monitor blood counts and liver function regularly.
• Avoid live vaccines during and after treatment until immune recovery.
• Use caution in patients with cardiovascular disease or thrombotic risk factors.

• Common: Upper respiratory infections, nausea, headache, elevated cholesterol.
• Hematologic: Anemia, neutropenia, lymphopenia.
• Serious: Serious infections, thrombosis, gastrointestinal perforations (rare).
• Others: Elevated liver enzymes, elevated creatine phosphokinase.

• Probenecid: Increases baricitinib levels; dose adjustment recommended.
• CYP3A4 inhibitors/inducers: Minimal effect; no routine dose adjustment.
• Immunosuppressants: Avoid combining with biologics due to increased infection risk.
• No significant food interactions.

• Regulatory agencies highlight thrombosis and infection risks; monitoring emphasized.
• Included in COVID-19 treatment protocols for hospitalized patients needing oxygen.
• Ongoing surveillance for long-term safety.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep container tightly closed.
• Do not freeze.
• Keep out of reach of children.