Schedule H

Intravenous infusion only

Form Strength

Lyophilised powder for reconstitution (IV infusion) 100 mg/vial

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Rheumatoid Arthritis (must be combined with Methotrexate)

Parameter Details

Starting dose 3 mg/kg IV at Weeks 0, 2, and 6 (induction phase)

Titration Increase dose by 1.5 mg/kg increments if inadequate response

Usual maintenance dose 3 mg/kg IV every 8 weeks

Maximum dose 10 mg/kg IV every 4 weeks

Key notes Concurrent methotrexate mandatory to reduce immunogenicity; reassess response by Week 14

1. Ankylosing Spondylitis

Parameter Details

Starting dose 5 mg/kg IV at Weeks 0, 2, and 6

Titration Not routinely required; may shorten interval in non-responders

Usual maintenance dose 5 mg/kg IV every 6–8 weeks

Maximum dose 10 mg/kg IV every 6 weeks (poor responders only)

Key notes Assess clinical response by Week 6; discontinue if no benefit by Week 12

1. Crohn's Disease — Moderate to Severe / Fistulising (Adults)

Parameter Details

Starting dose 5 mg/kg IV at Weeks 0, 2, and 6 (induction)

Titration Escalate to 10 mg/kg if loss of response

Usual maintenance dose 5 mg/kg IV every 8 weeks

Maximum dose 10 mg/kg IV every 8 weeks

Fistulising disease Same induction schedule; assess fistula closure by Week 14

Key notes Continue maintenance only if documented clinical or endoscopic response

1. Ulcerative Colitis (Adults)

Parameter Details

Starting dose 5 mg/kg IV at Weeks 0, 2, and 6

Titration Dose escalation to 10 mg/kg may be considered in secondary loss of response

Usual maintenance dose 5 mg/kg IV every 8 weeks

Maximum dose 10 mg/kg IV every 8 weeks

Key notes Assess colectomy-free survival and mucosal healing as endpoints

1. Psoriatic Arthritis

Parameter Details

Starting dose 5 mg/kg IV at Weeks 0, 2, and 6

Titration Not typically required

Usual maintenance dose 5 mg/kg IV every 8 weeks

Maximum dose 10 mg/kg IV every 8 weeks (rarely needed)

Key notes Can be used with or without methotrexate

1. Plaque Psoriasis (Moderate to Severe, Refractory)

Parameter Details

Starting dose 5 mg/kg IV at Weeks 0, 2, and 6

Titration Not applicable

Usual maintenance dose 5 mg/kg IV every 8 weeks

Maximum dose 5 mg/kg every 8 weeks (higher doses not established for psoriasis)

Key notes Reserve for patients failing conventional systemic therapy and phototherapy

Secondary Indications — Adults (Off-label)

Indication Dose Evidence Basis Notes

Behçet's Disease (refractory uveitis, mucocutaneous, or vascular) 5 mg/kg IV at Weeks 0, 2, 6, then every 8 weeks OFF-LABEL; case series; EULAR recommendations extrapolated Specialist only (Rheumatology/Ophthalmology)

Refractory Pulmonary/Extrapulmonary Sarcoidosis 3–5 mg/kg IV every 4–8 weeks OFF-LABEL; limited RCT data; observational studies Pulmonology or Clinical Immunology specialist only

Pyoderma Gangrenosum (refractory) 5 mg/kg IV induction, then every 8 weeks OFF-LABEL; small RCT and case reports Dermatology specialist only

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved in India)

1. Crohn's Disease (Children ≥6 years)

Parameter Details

Starting dose 5 mg/kg IV at Weeks 0, 2, and 6

Titration May increase frequency to every 6 weeks if loss of response

Usual maintenance dose 5 mg/kg IV every 8 weeks

Maximum dose 10 mg/kg IV every 8 weeks (based on specialist assessment)

Key notes Paediatric gastroenterologist supervision mandatory; monitor growth and nutrition

Secondary Indications — Paediatrics (Off-label)

Indication Dose Evidence Basis Notes

Juvenile Idiopathic Arthritis (polyarticular, refractory) 6 mg/kg IV at Weeks 0, 2, and 6, then every 8 weeks OFF-LABEL in India; used internationally (ACR/PRCSG guidance) Paediatric rheumatologist only; monitor for infection and growth

Ulcerative Colitis (Children ≥6 years) 5 mg/kg IV at Weeks 0, 2, and 6, then every 8 weeks OFF-LABEL; extrapolated from adult data and international use Paediatric gastroenterologist only

Not recommended below age 6 years except under specialist supervision with documented benefit-risk assessment.

• Active tuberculosis or other severe active infections (sepsis, invasive fungal infections, opportunistic infections)

• Known hypersensitivity to infliximab, murine proteins, or any excipient

• Moderate to severe heart failure (NYHA Class III or IV)

• Active demyelinating disease (multiple sclerosis, optic neuritis, Guillain-Barré syndrome)

• Concurrent administration with other biological DMARDs (anakinra, abatacept, etc.)

• Latent tuberculosis (mandatory screening before initiation; treat latent TB before starting infliximab)

• Chronic hepatitis B carriers (risk of reactivation; monitor HBV DNA; consider antiviral prophylaxis)

• History of recurrent infections or conditions predisposing to infections

• History of lymphoproliferative disorders or other malignancies

• Mild heart failure (NYHA Class I–II) — use with close monitoring

• Elderly patients (higher infection susceptibility)

• Concurrent immunosuppressants at high doses

• History of significant haematological abnormalities

• Patients scheduled to receive live vaccines (avoid during and for 6 months post-treatment)

• Prior infusion reactions (premedicate and slow infusion rate)

Parameter Details

Overall safety Limited human data; crosses placenta mainly in third trimester

Risk summary No definitive teratogenicity established; use only if benefit clearly outweighs risk

Preferred alternatives Certolizumab pegol (lower placental transfer) may be considered if biologic needed

When it may be used Active IBD or RA flares threatening pregnancy; specialist (rheumatology/gastroenterology + obstetrics) decision

Monitoring Foetal growth monitoring; neonatal infection surveillance

Important Avoid live vaccines in exposed infants for at least 6 months after last maternal dose

Parameter Details

Compatibility Generally compatible with breastfeeding

Drug levels in milk Minimal to undetectable (large molecule, poor oral bioavailability)

Preferred alternatives None specifically preferred; continue if clinically indicated

Infant monitoring Monitor for signs of infection, poor feeding, or failure to thrive

Vaccination Delay live vaccines (rotavirus, BCG) in breastfed infant if exposed in utero or via milk

Parameter Recommendation

Starting dose Standard adult dosing; no specific reduction required

Titration Slower escalation if combining with other immunosuppressants

Special risks Increased susceptibility to serious infections; more vigilant monitoring for TB reactivation

Additional considerations Assess baseline renal function before hydration during infusion; evaluate cardiac status before initiation

Interacting Drug(s) Effect / Mechanism Recommendation

Live vaccines (BCG, MMR, varicella, yellow fever, oral polio, rotavirus) Risk of disseminated infection due to immunosuppression CONTRAINDICATED during therapy and for 6 months after last dose

Other biological DMARDs (abatacept, anakinra, tocilizumab, natalizumab) Additive immunosuppression; markedly increased infection risk Avoid concurrent use

Cyclophosphamide Increased risk of severe myelosuppression and infection Avoid combination

Interacting Drug(s) Effect / Mechanism Recommendation

Methotrexate Reduces formation of anti-drug antibodies; used together in RA Beneficial combination; monitor for hepatotoxicity

Azathioprine / 6-Mercaptopurine Used together in IBD; additive immunosuppression Monitor CBC closely for bone marrow suppression

Corticosteroids (chronic use) Increased risk of infection with long-term combined immunosuppression Use lowest effective steroid dose; taper when possible

Rituximab Case reports of increased serious infections when used sequentially Allow adequate washout period; avoid overlap

Warfarin Isolated reports of altered INR Monitor INR closely after initiation

• Infusion-related reactions (headache, flushing, nausea, pruritus, urticaria, chest discomfort)

• Upper respiratory tract infections (nasopharyngitis, sinusitis)

• Abdominal pain, diarrhoea

• Fatigue, fever

• Rash

• Arthralgia, myalgia

• Transient elevation of liver transaminases

Adverse Effect Clinical Notes

Reactivation of latent TB May present atypically (extrapulmonary); screen and treat before initiation

Hepatitis B reactivation Can be fatal; mandatory HBsAg/anti-HBc screening pre-treatment

Serious bacterial infections (pneumonia, cellulitis, sepsis) Higher risk in elderly and those on concurrent immunosuppressants

Invasive fungal infections Histoplasmosis, aspergillosis (consider in endemic areas)

Lymphoma and other malignancies Small increased risk; counsel patients

Demyelinating disorders New-onset or exacerbation of MS, optic neuritis — discontinue permanently

Drug-induced lupus-like syndrome Monitor ANA; usually resolves on discontinuation

Severe hepatotoxicity / Autoimmune hepatitis Discontinue if significant; may require immunosuppression

Severe infusion reactions / Anaphylaxis Discontinue infusion; manage with adrenaline, steroids, antihistamines

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Rare; discontinue immediately and provide supportive care

Baseline (Before First Infusion)

• Tuberculin skin test (Mantoux) or Interferon-Gamma Release Assay (IGRA)

• Chest X-ray

• Hepatitis B serology (HBsAg, anti-HBc, anti-HBs) and Hepatitis C antibody

• Complete blood count with differential

• Liver function tests (ALT, AST, bilirubin, ALP)

• Serum creatinine

• ANA (if clinical suspicion of autoimmune disease or prior history)

After Initiation / Dose Change

• Monitor during infusion and for 1–2 hours post-infusion for infusion reactions

• CBC and LFT: at Week 4, then every 8–12 weeks

• Clinical assessment for infection at each visit

Long-term Monitoring

• Annual TB screening (clinical + chest X-ray) if ongoing risk factors

• Periodic skin examination for malignancy

• Monitor for neurological symptoms suggestive of demyelination

• Reassess disease activity to justify continuation

Brand Name Manufacturer Type

Remicade® Johnson & Johnson Originator

Infimab® Biocon Biosimilar

Remsima® Celltrion Biosimilar

Inflectra® Pfizer Biosimilar

Renflexis® Samsung Bioepis (distributed in India) Biosimilar

Infliximab (various) Multiple Indian biosimilar manufacturers Biosimilar

Type Approximate Price per 100 mg Vial

• Not included in NLEM

• Pricing variable by procurement channel (government tender vs private retail)

• Biosimilars widely used in India due to cost considerations

1. Mandatory TB screening — Latent TB reactivation can be fatal; always perform Mantoux/IGRA and chest X-ray before initiation; treat latent TB for at least 1 month before starting infliximab.

1. Hepatitis B vigilance — Screen all patients; in HBsAg-positive patients, initiate antiviral prophylaxis and monitor HBV DNA throughout therapy.

1. Premedication for infusion reactions — Consider hydrocortisone 100 mg IV, paracetamol, and antihistamine before infusion, especially if prior reactions occurred.

1. Biosimilar interchangeability — Biosimilars are therapeutically equivalent and substantially cheaper; switching is acceptable but maintain consistent brand within treatment course if possible.

1. Adherence preserves efficacy — Irregular dosing or prolonged gaps increase anti-drug antibody formation, leading to secondary treatment failure and infusion reactions.

1. Vaccine planning — Complete age-appropriate vaccinations (including pneumococcal and influenza) before starting therapy; avoid live vaccines during and for 6 months after treatment.

infliximab; TNF-alpha inhibitor; biologic DMARD; rheumatoid arthritis; Crohn's disease; ulcerative colitis; ankylosing spondylitis; psoriasis; biosimilar; immunosuppressant; monoclonal antibody; TB-screening; IV-infusion; Schedule H

RxIndia v1.0 — 13 Jun 2025

• CDSCO-approved product inserts (Remicade®, Infimab®)

• Indian Pharmacopoeia 2022

• API Textbook of Medicine (25th Edition)

• AIIMS Rheumatology and Gastroenterology Treatment Protocols

• ICMR Guidelines for Latent TB Infection Management

• Indian Association of Gastroenterology IBD Guidelines

• Indian Rheumatology Association Position Statements

• WHO Model List of Essential Medicines (paediatric Crohn's reference)

• Published Indian specialist consensus and practice patterns