Schedule H

Oral

Formulation Strengths Available

Delayed-release (enteric-coated) tablets 180 mg, 360 mg

Important Note: Mycophenolate sodium delayed-release tablets are NOT interchangeable with mycophenolate mofetil (MMF) on a mg-to-mg basis due to different pharmacokinetics and bioavailability.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

✦ Prophylaxis of Organ Rejection in Renal Transplant

(Used in combination with ciclosporin and corticosteroids)

Parameter Details

Starting dose 720 mg/day orally in 2 divided doses (360 mg twice daily)

Titration Not applicable; start at therapeutic dose immediately post-transplant

Usual maintenance dose 720 mg twice daily (1440 mg/day total)

Maximum dose 1440 mg/day (higher doses not recommended due to increased GI toxicity)

Clinical Notes:

• Initiate as soon as possible after transplant surgery

• Must be used in combination with ciclosporin (or tacrolimus) and corticosteroids — never as monotherapy

• Delayed-release formulation should be swallowed whole; do not crush, chew, or break tablets

• Take on empty stomach or at consistent times to maintain stable drug levels

• If switching from mycophenolate mofetil: 720 mg mycophenolate sodium ≈ 1000 mg mycophenolate mofetil (equimolar doses)

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

Indication Dose Duration Notes

Lupus Nephritis 720–1440 mg/day in 2 divided doses Induction: 6 months; Maintenance: long-term OFF-LABEL — Specialist only; used when mycophenolate mofetil poorly tolerated due to GI effects; based on Indian nephrology practice

Autoimmune Hepatitis (Azathioprine-refractory) 720–1080 mg/day in 2 divided doses Long-term maintenance OFF-LABEL — Specialist only; limited Indian hepatology experience; case series evidence

Myasthenia Gravis (Steroid-sparing) 720–1440 mg/day in 2 divided doses Long-term OFF-LABEL — Specialist only; Indian neurology practice when azathioprine contraindicated

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

✦ Prophylaxis of Organ Rejection in Paediatric Renal Transplant

Eligibility: Age ≥5 years and body weight ≥20 kg

Parameter Details

Starting dose 400 mg/m² BSA twice daily

Titration Adjust based on clinical response, tolerability, and therapeutic drug monitoring if available

Usual maintenance dose 400–600 mg/m² BSA twice daily

Maximum dose 720 mg twice daily (not to exceed adult dose of 1440 mg/day)

BSA-based Dosing Reference:

BSA (m²) Approximate Dose per Administration Daily Total

0.5–0.75 180–270 mg twice daily 360–540 mg/day

0.76–1.0 270–360 mg twice daily 540–720 mg/day

1.0–1.25 360–540 mg twice daily 720–1080 mg/day

1.25 540–720 mg twice daily 1080–1440 mg/day

Monitoring Requirements:

• CBC with differential weekly for first month, then every 2 weeks for 2 months, then monthly

• Renal function tests monthly

• Monitor for GI symptoms (diarrhoea, abdominal pain) and signs of infection

Clinical Notes:

• Always used in combination with calcineurin inhibitor and corticosteroids

• Tablets must be swallowed whole — if child cannot swallow tablets, mycophenolate mofetil oral suspension may be preferred

• Specialist paediatric nephrology/transplant supervision mandatory

Secondary Indications — Paediatric Doses (Off-label, if any)

Indication Dose Duration Notes

Juvenile Lupus Nephritis 400–600 mg/m² BSA twice daily Induction: 6 months; Maintenance: long-term OFF-LABEL — Specialist only; paediatric rheumatology/nephrology supervision; Indian specialist practice

Age Restriction Statement:

• Not recommended below 5 years of age or weight <20 kg except under specialist transplant/immunology supervision with documented benefit-risk assessment

Immediate post-transplant (delayed graft function) Standard dosing may be used initially; monitor for accumulation

Haemodialysis Drug not significantly removed by dialysis; no supplemental dose required

Peritoneal dialysis Limited data; use standard dosing with close monitoring

Note: Increased free mycophenolic acid (MPA) concentrations may occur in severe renal impairment; enhanced monitoring for adverse effects required.

• Known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or any excipient

• Pregnancy (teratogenic — documented risk of congenital malformations and pregnancy loss)

• Breastfeeding

• Concomitant use with azathioprine (overlapping mechanism; increased myelosuppression risk without additional benefit)

• History of gastrointestinal disease (peptic ulcer, GI bleeding, inflammatory bowel disease) — increased risk of GI complications

• Pre-existing bone marrow suppression or concurrent myelosuppressive therapy

• Active serious infections (bacterial, viral, fungal) — may require temporary discontinuation

• Hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (Lesch-Nyhan or Kelley-Seegmiller syndrome)

• Elderly patients with reduced immune reserve

• Concurrent use with other immunosuppressants (increased infection and malignancy risk)

• Avoid live vaccines during therapy and for at least 3 months after discontinuation

• Risk of BK virus nephropathy and CMV disease in transplant recipients

• Sun protection advised (increased skin malignancy risk with long-term use)

Parameter Details

Safety Category Contraindicated — Teratogenic (increased risk of first-trimester pregnancy loss and congenital malformations including ear, facial, cardiac, and limb defects)

Preferred Alternatives Azathioprine (established safety profile in pregnancy for immunosuppression)

When May Be Used Only if no suitable alternative exists; requires specialist transplant/rheumatology team decision with documented informed consent

Contraception Requirements Women of childbearing potential must use two reliable methods of contraception during treatment and for 6 weeks after discontinuation

Pre-treatment Negative pregnancy test required within 1 week before starting therapy

Monitoring If exposure occurs: detailed fetal anomaly ultrasound; genetic counselling recommended

Parameter Details

Compatibility Contraindicated — avoid breastfeeding during treatment

Drug Levels in Milk Unknown but potential for significant transfer based on pharmacokinetic properties

Preferred Alternative Azathioprine (if immunosuppression required postpartum; established compatibility with breastfeeding)

If Inadvertent Exposure Monitor infant for GI symptoms (diarrhoea, feeding difficulties), growth, and signs of immunosuppression (infections, leucopenia)

Parameter Recommendation

Starting Dose Lower end of dosing range (360 mg twice daily); titrate based on tolerance

Titration Slower escalation if required; allow longer intervals between dose adjustments

Special Risks Increased susceptibility to infections; higher risk of GI adverse effects; age-related decline in renal function may affect drug clearance

Monitoring More frequent CBC monitoring; assess renal function regularly; monitor for signs of opportunistic infections

Interacting Drug Mechanism/Effect Recommendation

Antacids containing magnesium/aluminium hydroxide Decreased absorption of mycophenolate sodium Administer antacids at least 2 hours before or after mycophenolate sodium

Cholestyramine and bile acid sequestrants Interrupts enterohepatic recirculation; significantly reduces MPA exposure Avoid concomitant use

Aciclovir / Valaciclovir Competitive tubular secretion; increased levels of both MPA glucuronide and aciclovir Monitor for toxicity of both drugs; dose adjustment may be required in renal impairment

Ganciclovir / Valganciclovir Additive myelosuppression; competitive renal excretion Monitor CBC closely; dose reduction of either agent may be required

Live vaccines (MMR, varicella, BCG, oral typhoid) Risk of disseminated vaccine infection due to immunosuppression Contraindicated during therapy

Azathioprine Overlapping mechanism (purine synthesis inhibition); additive myelosuppression Avoid combination

Interacting Drug Mechanism/Effect Recommendation

Ciclosporin Decreases enterohepatic recirculation of MPA; reduces MPA exposure Standard combination in transplant; no dose adjustment typically required; monitor clinical response

Tacrolimus May increase MPA exposure compared to ciclosporin-based regimens Monitor for MPA toxicity; therapeutic drug monitoring helpful

Rifampicin Induces UGT enzymes; reduces MPA levels by 30–70% Monitor for reduced efficacy; consider alternative antimycobacterial if feasible; may need increased mycophenolate dose under specialist guidance

Probenecid Inhibits tubular secretion of MPAG; increases MPA exposure Monitor for MPA toxicity

Oral contraceptives Potential for reduced contraceptive efficacy (theoretical) Recommend additional barrier method; use two forms of contraception

Sevelamer / Calcium-based phosphate binders May reduce MPA absorption Administer separately; monitor clinical response

Ciprofloxacin / Norfloxacin May reduce MPA levels in immediate post-transplant period (altered gut flora reducing enterohepatic recirculation) Clinical significance uncertain; monitor for efficacy

• Gastrointestinal: Diarrhoea (most common), nausea, vomiting, abdominal pain, dyspepsia

• Haematological: Leucopenia, anaemia, thrombocytopenia

• Infections: Increased frequency (upper respiratory tract infections, urinary tract infections, candidiasis)

• General: Fatigue, headache, fever

• Dermatological: Acne, rash

• Metabolic: Hypercholesterolaemia, hypophosphataemia, hypokalaemia

Adverse Effect Clinical Notes

Progressive Multifocal Leukoencephalopathy (PML) Rare but potentially fatal JC virus reactivation; presents with neurological deficits; requires immediate discontinuation and specialist neurology input

CMV Disease Particularly in seronegative recipients of seropositive donors; may require dose reduction/interruption and antiviral therapy

BK Virus Nephropathy Risk of graft loss in renal transplant recipients; requires dose reduction

Severe Neutropenia / Agranulocytosis Withhold therapy if ANC <1,300/mm³; may require G-CSF support

GI Perforation / Severe GI Bleeding Higher risk in patients with pre-existing GI disease; may require surgical intervention

Malignancy Increased risk of lymphoma and non-melanoma skin cancers with long-term immunosuppression

Serious Opportunistic Infections Fungal, protozoal, and viral (including herpes zoster, hepatitis reactivation)

Pure Red Cell Aplasia (PRCA) Rare; may require discontinuation and switch to alternative agent

Phase Parameters

Baseline CBC with differential; LFTs; serum creatinine; pregnancy test (women of childbearing potential); viral serology (CMV IgG, hepatitis B/C, EBV)

First Month CBC weekly

Months 2–3 CBC every 2 weeks

Months 4–12 CBC monthly

Long-term (>1 year) CBC every 1–3 months; annual dermatological examination for skin malignancy; periodic renal function assessment

Additional Monitor for CMV and BK viral load in transplant recipients (as per institutional protocol); therapeutic drug monitoring of MPA may be considered in select cases

Brand Name Manufacturer

Myfortic Novartis

Mofetyl-S Panacea Biotec

Mofecon-S Intas

Mycept-S Panacea Biotec

Important: These enteric-coated mycophenolate sodium preparations are distinct from mycophenolate mofetil brands (e.g., Cellcept, Mycept) and should not be substituted interchangeably.

Notes:

• Not included in NLEM

• May be available under selected government transplant support schemes in tertiary centres

• Higher cost compared to mycophenolate mofetil but may offer better GI tolerability

• Not interchangeable with MMF: Mycophenolate sodium 720 mg provides equivalent mycophenolic acid exposure to mycophenolate mofetil 1000 mg — direct mg-to-mg substitution is incorrect

• GI tolerability advantage: Enteric-coated formulation may reduce upper GI symptoms compared to MMF; useful in patients with MMF-related dyspepsia or nausea

• Never use as monotherapy: Always combine with calcineurin inhibitor (ciclosporin or tacrolimus) and corticosteroids in transplant setting

• Strict contraception counselling mandatory: Document pregnancy prevention counselling before initiating therapy in women of childbearing potential; teratogenicity risk is significant

• Diarrhoea management: Most common adverse effect; often dose-related; temporary dose reduction may help; rule out CMV colitis or other infectious causes in transplant recipients

• Infection surveillance: Maintain high index of suspicion for opportunistic infections; educate patients on infection prevention measures

• Avoid live vaccines: Ensure vaccination status is updated before starting immunosuppression when possible

mycophenolate sodium; mycophenolic acid; immunosuppressant; renal transplant; lupus nephritis; organ rejection prophylaxis; pregnancy-contraindicated; teratogenic; enteric-coated; specialist-use

RxIndia v1.1 — 27 Jan 2026

• CDSCO Product Information

• Indian Pharmacopoeia / National Formulary of India (NFI)

• API Textbook of Medicine

• AIIMS Renal Transplantation Protocols

• Indian Society of Organ Transplantation (ISOT) Guidelines

• Indian Society of Nephrology — Consensus Statements on Lupus Nephritis

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• WHO Essential Medicines List (supportive reference)