Schedule H

Oral

• Baricitinib 2 mg tablets

• Baricitinib 4 mg tablets

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Rheumatoid Arthritis (Moderate to Severe Active Disease)

Indicated in adults with inadequate response or intolerance to one or more conventional synthetic DMARDs (csDMARDs) or biologic DMARDs.

Parameter Recommendation

Starting dose 4 mg once daily orally

Titration Reduce to 2 mg once daily if at increased infection risk, age >75 years, or eGFR 30–59 mL/min

Usual maintenance dose 2–4 mg once daily

Maximum dose 4 mg once daily

Clinical Notes:

• May be used as monotherapy or in combination with methotrexate

• Monotherapy preferred when methotrexate is contraindicated or not tolerated

• Discontinue if no clinical improvement observed at 12 weeks

• Not a first-line agent; use only after csDMARD failure

• Mandatory screening: Latent TB (Mantoux/IGRA), Hepatitis B/C serology before initiation

1. COVID-19 (Hospitalised Patients — Restricted Emergency Use)

Approved by CDSCO under restricted emergency use for moderate to severe COVID-19 requiring oxygen supplementation with evidence of systemic inflammation.

Parameter Recommendation

Starting dose 4 mg once daily orally

Titration Not applicable

Usual maintenance dose 4 mg once daily

Maximum dose 4 mg once daily

Duration Up to 14 days or until hospital discharge (whichever is earlier)

Clinical Notes:

• Use in combination with corticosteroids (IV dexamethasone preferred) ± remdesivir

• Reserved for hospitalised patients requiring supplemental oxygen with elevated inflammatory markers (CRP, ferritin, D-dimer)

• Decision must be specialist-driven (intensivist/pulmonologist/infectious disease specialist)

• Monitor D-dimer, inflammatory markers, oxygen saturation, and thrombotic complications closely

• Dose adjustment required for eGFR 30–59 mL/min (reduce to 2 mg once daily)

Secondary Indications — Adults (Off-label, if any):

Systemic Lupus Erythematosus (SLE) — OFF-LABEL

Parameter Details

Dose 2–4 mg once daily

Duration Long-term; individualized

Specialist only Yes — rheumatologist supervision mandatory

Evidence basis Phase II/III trial data; not yet standard care in Indian rheumatology practice

Caution Increased adverse event risk; limited long-term safety data available

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India):

Not approved for use in children below 18 years in India.

Secondary Indications — Paediatrics (Off-label, if any):

Juvenile Idiopathic Arthritis (JIA) — OFF-LABEL

Parameter Details

Minimum age Generally not before 2 years

Dose Weight-based; protocols vary (e.g., 2 mg once daily for children ≥10 kg)

Duration Long-term; individualized based on response

Specialist only Yes — paediatric rheumatologist supervision mandatory

Evidence basis Ongoing clinical trials; not standard of care in India

Monitoring CBC with differential, LFTs, lipid profile, infection screening before and during therapy

Statement: Use in children below 18 years is not recommended except under specialist paediatric rheumatologist supervision in exceptional circumstances. Not for routine clinical use outside research settings.

• Known hypersensitivity to baricitinib or any excipient

• Active serious infections (including active tuberculosis, serious bacterial, fungal, viral, or opportunistic infections)

• Severe hepatic impairment (Child-Pugh C)

• Pregnancy (confirmed or planned)

• eGFR <30 mL/min/1.73m²

• Concurrent use with other JAK inhibitors or biologic DMARDs

• Concurrent use with potent immunosuppressants (cyclosporine, tacrolimus, azathioprine in full immunosuppressive doses)

• Age >65 years: Increased risk of serious infections, thrombosis, and malignancy

• History of recurrent or chronic infections

• Chronic lung disease (COPD, bronchiectasis, interstitial lung disease)

• History of venous thromboembolism (DVT/PE) or known thrombophilia

• Patients with cardiovascular risk factors

• History of malignancy (evaluate risk-benefit; avoid if active malignancy)

• Diverticular disease or concurrent NSAID use (risk of GI perforation)

• Latent tuberculosis (initiate anti-TB therapy before starting baricitinib)

• Chronic viral hepatitis (HBV/HCV) — consult hepatologist; risk of reactivation

• Low absolute lymphocyte count (<500 cells/mm³) or absolute neutrophil count (<1000 cells/mm³) — do not initiate

• Low haemoglobin (<8 g/dL) — do not initiate

Parameter Details

Risk assessment Contraindicated; not to be used during pregnancy

Fetal risk Animal studies demonstrate fetal toxicity and teratogenicity

Preferred alternatives Hydroxychloroquine, sulfasalazine, or low-dose corticosteroids for RA during pregnancy

Pre-conception Discontinue at least 1 week before planned conception

Specialist input Mandatory — rheumatologist and obstetrician coordination required

Monitoring if inadvertent exposure Detailed fetal anomaly scan; close obstetric surveillance

Parameter Details

Breastfeeding compatibility Not recommended; avoid breastfeeding during treatment

Drug levels in milk Expected to be excreted in breast milk; clinical significance unknown

Preferred alternatives Hydroxychloroquine, sulfasalazine (compatible with breastfeeding in RA)

Monitoring in infant Not applicable — drug exposure to be avoided

Parameter Recommendation

Starting dose 2 mg once daily in patients >75 years

Titration Conservative; maintain lowest effective dose

Specific risks Increased incidence of serious infections, herpes zoster, thrombosis, cardiovascular events, and malignancy

Monitoring More frequent monitoring of renal function, CBC, and clinical signs of infection required

Clinical note Careful risk-benefit assessment essential before initiating in elderly patients

Interacting Drug/Class Effect & Management

Strong OAT3 inhibitors (probenecid) Significantly increases baricitinib exposure (~2-fold); avoid combination or reduce baricitinib dose to 2 mg once daily

Other JAK inhibitors Contraindicated — additive immunosuppression and toxicity risk

Biologic DMARDs (adalimumab, tocilizumab, etanercept, etc.) Contraindicated — increased immunosuppression and serious infection risk

Potent immunosuppressants (cyclosporine, tacrolimus, azathioprine) Avoid combination — increased serious infection and malignancy risk

Live vaccines Contraindicated during therapy; administer live vaccines at least 2 weeks before initiation or after appropriate washout

Interacting Drug/Class Effect & Management

CYP enzyme inducers (rifampicin, carbamazepine, phenytoin) May reduce baricitinib efficacy; monitor clinical response closely

NSAIDs Additive renal toxicity and increased GI perforation risk; monitor renal function regularly

Anticoagulants/antiplatelets (warfarin, aspirin, clopidogrel) May increase bleeding risk; use with caution and clinical judgment

Statins Baricitinib can elevate lipids; monitor lipid profile and adjust statin dose if needed

Methotrexate Combination permitted and commonly used; no dose adjustment required for either drug

• Upper respiratory tract infections

• Nausea

• Headache

• Elevated ALT/AST (transient, mild)

• Hyperlipidaemia (elevated LDL cholesterol, triglycerides)

• Herpes zoster (localized, dermatomal)

• Neutropenia (mild)

• Acne

• Serious infections (tuberculosis, invasive fungal infections, bacterial sepsis, opportunistic infections) — may require discontinuation and urgent treatment

• Venous thromboembolism (deep vein thrombosis, pulmonary embolism) — discontinue immediately if suspected

• Arterial thrombotic events (myocardial infarction, stroke)

• Gastrointestinal perforation (particularly with concurrent NSAIDs or in patients with diverticular disease)

• Severe cytopenias (thrombocytopenia, severe neutropenia, lymphopenia)

• Hepatotoxicity (drug-induced liver injury)

• Malignancy (lymphoma, solid tumours — long-term risk, especially in elderly)

• Reactivation of latent infections (tuberculosis, hepatitis B)

Phase Parameters

Baseline (before initiation) CBC with differential, LFTs (ALT, AST), serum creatinine/eGFR, fasting lipid profile, TB screening (Mantoux/IGRA), Hepatitis B surface antigen, anti-HCV antibody, chest X-ray

After 4 weeks CBC with differential, LFTs, renal function

Every 3 months (first year) CBC, LFTs, renal function, lipid profile

Long-term (annually) TB screening (if high-risk population), lipid profile, assessment for malignancy signs, cardiovascular risk evaluation

COVID-19 use Daily monitoring of D-dimer, CRP, ferritin, oxygen saturation, clinical signs of thrombosis

• Olumiant (Eli Lilly)

• Barijak (Zydus Cadila)

• Barinat (Natco Pharma)

• Barikind (Glenmark)

• Jaknat (Intas Pharmaceuticals)

• Baritor (Torrent Pharmaceuticals)

Available in 2 mg and 4 mg tablet strengths

Notes:

• Not included in National List of Essential Medicines (NLEM) 2022

• Not under NPPA price control

• May be available under PMBJP scheme in select states

• Significant price variation between originator (Olumiant) and generic brands

• Mandatory pre-treatment screening: Always screen for latent TB and hepatitis B before initiation; treat latent TB before starting baricitinib

• Not a first-line therapy: Reserve for patients with inadequate response or intolerance to conventional DMARDs; do not use as initial therapy for RA

• Lowest effective dose principle: Use 2 mg once daily whenever possible, especially in elderly, those with infection history, or moderate renal impairment

• Thrombosis awareness: Counsel patients about symptoms of DVT/PE; avoid in patients with high thrombotic risk without careful specialist evaluation

• Vaccine planning: Complete all recommended vaccinations (including herpes zoster vaccine) before starting therapy; avoid live vaccines during treatment

• COVID-19 use is adjunctive: Only for hospitalised oxygen-requiring patients under specialist supervision; not for outpatient management

baricitinib; JAK inhibitor; DMARD; rheumatoid arthritis; COVID-19 adjunct; immunosuppressant; TB-screening-required; hepatitis-B-screening; renal-dose-adjustment; elderly-caution; thrombosis-risk; Schedule H

RxIndia v1.0 — 02 Jun 2025

• CDSCO approved prescribing information

• Indian Rheumatology Association (IRA) guidelines for management of rheumatoid arthritis

• AIIMS COVID-19 Treatment Protocol (2021)

• ICMR National Guidelines on COVID-19 Management

• API Textbook of Medicine (Rheumatoid Arthritis chapter)

• National Formulary of India (NFI)

• NLEM 2022 (Baricitinib not listed)

• Manufacturer product information leaflets (Olumiant, Barinat, Barikind)