Schedule H

Oral, Intravenous

• Tablets: 250 mg, 500 mg

• Capsules: 250 mg

• Oral Suspension: 200 mg/mL

• Injection (lyophilized powder for reconstitution): 500 mg per vial

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Prophylaxis of Organ Rejection in Renal Transplantation (with ciclosporin and corticosteroids)

Parameter Details

Starting dose 1 g orally twice daily (initiate within 72 hours of transplant)

Titration Not applicable — full dose from initiation

Usual maintenance dose 1–1.5 g twice daily

Maximum dose 3 g/day

IV dosing 1 g IV over ≥2 hours twice daily (if oral not feasible; max 14 days)

Clinical notes Must be used in combination with calcineurin inhibitor (ciclosporin or tacrolimus) + corticosteroid

1. Prophylaxis of Organ Rejection in Hepatic Transplantation (with ciclosporin and corticosteroids)

Parameter Details

Starting dose 1 g orally twice daily

Titration Not applicable

Usual maintenance dose 1–1.5 g twice daily

Maximum dose 3 g/day

Clinical notes IV administration data limited in hepatic transplant; prefer oral route

1. Prophylaxis of Organ Rejection in Cardiac Transplantation (with ciclosporin and corticosteroids)

Parameter Details

Starting dose 1.5 g orally twice daily

Titration Not applicable

Usual maintenance dose 1.5 g twice daily

Maximum dose 3 g/day

Clinical notes Higher starting dose compared to renal/hepatic transplant

Secondary Indications — Adults (Off-label)

Indication Dose Duration Supervision Evidence Basis

Lupus Nephritis (Class III–V) — OFF-LABEL Induction: 1–1.5 g twice daily; Maintenance: 0.5–1 g twice daily Induction: 6 months; Maintenance: Long-term Specialist only ALMS trial; Indian nephrology specialist practice

Myasthenia Gravis (Refractory) — OFF-LABEL 1–2 g/day in 2 divided doses Long-term as steroid-sparing agent Specialist only Indian neurology protocols

ANCA-associated Vasculitis (Maintenance) — OFF-LABEL 1–2 g/day in 2 divided doses Long-term after induction remission Specialist only Indian rheumatology specialist practice

Interstitial Lung Disease (Autoimmune) — OFF-LABEL 1–2 g/day in 2 divided doses Long-term Specialist only Indian pulmonology specialist use

PAEDIATRIC DOSING (Specialist Only)

Primary Indication (Approved / Standard in India)

Prophylaxis of Organ Rejection in Paediatric Renal Transplant

Parameter Details

Age ≥2 years

Starting dose 600 mg/m² orally twice daily

Titration Adjust based on tolerability and blood counts

Usual maintenance dose 600 mg/m² twice daily

Maximum dose 2 g/day (or adult maximum if weight allows)

Clinical notes Oral suspension available for accurate paediatric dosing; requires transplant nephrology oversight

Body Surface Area-Based Dosing Table:

BSA (m²) Dose per administration Frequency

0.5–0.75 300–450 mg Twice daily

0.75–1.0 450–600 mg Twice daily

1.0–1.25 600–750 mg Twice daily

1.25–1.5 750–900 mg Twice daily

1.5 900–1000 mg Twice daily

Secondary Indications — Paediatric Doses (Off-label)

Indication Dose Duration Supervision Evidence Basis

Juvenile SLE with Nephritis — OFF-LABEL 600 mg/m²/dose twice daily (max 2 g/day) Induction: 6 months; Maintenance: 1–2 years Specialist only IAP guidelines; Indian paediatric nephrology practice

JIA-associated Chronic Uveitis — OFF-LABEL 600–1200 mg/m²/day in 2 divided doses (max 2 g/day) Long-term Specialist only Indian paediatric rheumatology/ophthalmology practice

Safety Monitoring in Paediatrics:

• Complete blood count with differential weekly for first month

• Liver and renal function tests monthly

• Growth parameters and blood pressure monitoring

• Infection surveillance

Age Restriction: Not recommended below 2 years of age except under transplant specialist supervision due to limited safety data.

Mild–Moderate impairment No specific dose adjustment in stable transplant recipients

• Known hypersensitivity to mycophenolate mofetil or mycophenolic acid

• Pregnancy (absolute contraindication — teratogenic)

• Breastfeeding

• Concurrent use with azathioprine (overlapping myelosuppressive toxicity)

• Active serious systemic infections

• History of gastrointestinal ulceration or active GI disease (increased risk of GI intolerance and bleeding)

• Latent or active infections (TB, CMV, HBV, HCV — risk of reactivation)

• Pre-existing haematological disorders (baseline neutropenia, anaemia)

• Live vaccination during treatment (contraindicated)

• Women of childbearing potential — strict contraception mandatory

• Hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (Lesch-Nyhan syndrome)

Parameter Details

Risk category Teratogenic — Absolute contraindication (Category D equivalent)

Risk Associated with first-trimester miscarriage and congenital malformations (ear, limb, cardiac, facial abnormalities)

Preferred alternatives Azathioprine is preferred immunosuppressant if required during pregnancy under specialist guidance

When it may be used Should NOT be used — discontinue at least 6 weeks before planned conception

What to monitor Pregnancy test before initiation, periodic pregnancy testing during therapy, strict dual contraception

Parameter Details

Compatibility Contraindicated during breastfeeding

Drug levels in milk Excreted into breast milk; potential for immunosuppression in infant

Preferred alternatives Azathioprine may be acceptable (low milk levels)

What to monitor in infant If inadvertent exposure: monitor for infections, neutropenia, weight gain, feeding

Parameter Recommendation

Starting dose Begin at lowest effective dose within standard range

Titration Slower titration may be needed based on tolerability

Special risks Higher susceptibility to myelosuppression, infections, and malignancy; reduced renal reserve

Monitoring More frequent CBC and renal function assessment

Drug Interaction Management

Azathioprine Overlapping myelosuppressive toxicity Avoid concurrent use

Live vaccines (BCG, MMR, OPV, Varicella) Risk of disseminated vaccine infection due to immunosuppression Contraindicated during therapy

Acyclovir / Ganciclovir / Valganciclovir Additive bone marrow suppression; competitive tubular secretion increases both drug levels Avoid if possible; if essential, monitor CBC closely

Cholestyramine Interrupts enterohepatic recirculation → markedly reduces mycophenolic acid levels Avoid concomitant use

Antacids (Mg/Al-containing) Significantly reduces mycophenolate absorption Space administration by at least 2 hours

Drug Interaction Management

Ciclosporin Decreases mycophenolic acid levels by inhibiting enterohepatic recirculation Monitor MPA levels if available; may need dose adjustment

Tacrolimus May increase mycophenolic acid exposure; additive nephrotoxicity possible Monitor renal function and drug levels

Rifampicin Induces hepatic enzymes → lowers mycophenolic acid levels Avoid if possible; monitor for reduced efficacy

Cotrimoxazole / Linezolid Additive neutropenia risk Monitor CBC regularly

Oral contraceptives Mycophenolate may reduce contraceptive efficacy Use dual contraception (barrier + hormonal)

Proton pump inhibitors May reduce mycophenolate absorption Clinical significance uncertain; monitor for efficacy

• Nausea, vomiting, diarrhoea, abdominal pain

• Leukopenia, anaemia, thrombocytopenia

• Infections (bacterial, viral, fungal — common)

• Acne, skin rash

• Hypertension

• Peripheral oedema

• Headache

• Insomnia

Adverse Effect Clinical Significance

Severe neutropenia / Pancytopenia Requires dose interruption or discontinuation

Opportunistic infections (CMV, BK virus, PML) May require antiviral prophylaxis; PML is rare but often fatal

Progressive Multifocal Leukoencephalopathy (PML) JC virus reactivation — discontinue immediately if suspected

GI perforation / Severe haemorrhage Rare; requires immediate surgical evaluation

Lymphoproliferative disorders / Malignancy Increased risk with prolonged use; regular screening essential

Pure Red Cell Aplasia (PRCA) Rare; consider dose reduction or switching agents

Phase Parameters Frequency

Baseline CBC with differential, LFTs, serum creatinine, pregnancy test (women of childbearing age), viral serology (HBV, HCV, CMV, EBV) Before initiation

First 3 months CBC with differential Weekly × 4 weeks, then biweekly × 8 weeks

After 3 months CBC, LFTs, renal function Monthly

Long-term CBC, LFTs, renal function, infection surveillance Every 1–3 months

Additional Dermatologic examination for skin malignancy, annual cervical smear (female patients) Annually

• Cellcept® (Roche)

• Mycept® (Panacea Biotec)

• Mycofit® (Intas)

• Mofilet® (Emcure)

• Renodapt® (Biocon)

• MMF® (Cadila)

• Mofetyl® (Dr. Reddy's)

Numerous generic formulations also available.

Listed under NLEM — price ceiling applicable for scheduled formulations. Available in Jan Aushadhi stores at reduced cost.

1. Triple therapy mandatory in transplant — Always combine with calcineurin inhibitor (ciclosporin or tacrolimus) and corticosteroid for transplant prophylaxis; monotherapy is ineffective.

1. Pregnancy is absolute contraindication — Azathioprine is the preferred alternative if immunosuppression is required during pregnancy; counsel all women of childbearing potential about strict contraception.

1. IV to oral transition — Switch to oral formulation as early as tolerated; IV use should not exceed 14 days.

1. CMV prophylaxis — Consider valganciclovir prophylaxis in high-risk transplant recipients (D+/R- serostatus) to prevent CMV disease.

1. GI intolerance management — Divide doses, take with food, or consider enteric-coated mycophenolic acid (myfortic) if available for persistent GI symptoms.

1. Drug-drug interaction awareness — Avoid concomitant azathioprine; reduce or space antacids; be cautious with ciclosporin (reduces MPA levels).

mycophenolate-mofetil; immunosuppressant; transplant; renal-transplant; lupus-nephritis; pregnancy-contraindicated; antimetabolite; NLEM-India; paediatric-dosing; specialist-only

RxIndia v1.0 — 14 May 2025

• CDSCO Product Insert (Mycophenolate Mofetil)

• Indian Pharmacopoeia / National Formulary of India

• NLEM 2022

• API Textbook of Medicine, 11th Edition

• AIIMS Nephrology Protocols

• Indian Society of Nephrology Guidelines

• IAP Guidelines (Paediatric SLE)

• Indian Society of Organ Transplantation (ISOT) Practice Standards

• ALMS Trial (for lupus nephritis — off-label evidence)