Cellcept (Innovator)

Mycophenolate mofetil (360mg)
Price: Approx. ₹2500 - ₹3200 for a strip of 10 tablets (500mg equivalent; 360mg may vary)
Mfr: Roche Products (India) Pvt. Ltd. | Form: Tablet, Capsule, Oral Suspension, Injection

📋 Clinical Overview

Mycophenolate mofetil (MMF) is a prodrug of mycophenolic acid (MPA), a potent, selective, non-competitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). It is an immunosuppressive agent primarily used to prevent organ rejection in transplant recipients. The 360mg strength is a common formulation used in India, often for maintenance therapy or in specific dosing regimens.

💊 Dosage & Administration

Adult: Renal Transplant: 720 mg (i.e., 360mg x 2 tablets) orally twice daily (total 1440 mg/day). Cardiac Transplant: 1500 mg orally twice daily. Hepatic Transplant: 1500 mg orally twice daily. For autoimmune diseases (e.g., Lupus Nephritis): 360-720 mg twice daily, titrated based on response and tolerance.

Note: Administer on an empty stomach, 1 hour before or 2 hours after food to avoid reduced MPA exposure. Tablets should be swallowed whole with a glass of water; do not crush, break, or chew. If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose. Do not double the dose. For women of childbearing potential, pregnancy must be excluded before initiation and two reliable forms of contraception must be used.

⚠️ Contraindications

  • Hypersensitivity to mycophenolate mofetil, mycophenolic acid, or any component of the formulation.
  • Pregnancy and women of childbearing potential not using highly effective contraception (due to high risk of miscarriage and congenital malformations).

🔬 Mechanism of Action

MMF is a prodrug that is rapidly hydrolyzed to mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), specifically the type II isoform which is upregulated in activated lymphocytes. This inhibition blocks the de novo pathway of guanosine nucleotide synthesis, a pathway crucial for DNA and RNA synthesis in T- and B-lymphocytes. This leads to cytostatic arrest of lymphocyte proliferation, suppressing cell-mediated immune responses and antibody formation.

🤕 Side Effects

  • Diarrhea (up to 30-40%)
  • Nausea and vomiting
  • Abdominal pain
  • Leukopenia (neutropenia)
  • Anemia
  • Fatigue
  • Headache
  • Upper respiratory tract infection
  • Insomnia

🤰 Special Populations

Pregnancy: Pregnancy Category D. Contraindicated. Associated with a high risk of first-trimester pregnancy loss and congenital malformations (including external ear, facial, cardiovascular, CNS, and limb abnormalities). Women of childbearing potential must have a negative pregnancy test within 1 week prior to initiation and use two reliable forms of contraception for 4 weeks before, during, and 6 weeks after therapy.

Driving: May cause dizziness, somnolence, or blurred vision. Patients should be cautioned about operating machinery or driving until they know how MMF affects them.

🔄 Drug Interactions

Acyclovir, Valacyclovir, Ganciclovir, ValganciclovirCompetition for renal tubular secretion may increase plasma concentrations of both MPA and the antiviral drug, potentially increasing toxicity (myelosuppression, neuropenia).Major
Antacids with Magnesium and Aluminum HydroxidesDecrease absorption of MMF, reducing MPA bioavailability by up to 33%. Administer MMF at least 2 hours apart.Moderate
Cholestyramine and other bile acid sequestrantsInterrupt enterohepatic recirculation, significantly reducing MPA exposure (AUC). Avoid concomitant use.Major
Cyclosporine (CsA)CsA inhibits the MRP2 transporter, reducing biliary excretion of MPAG, thereby decreasing enterohepatic recirculation and MPA exposure. Switching from CsA to other calcineurin inhibitors may increase MPA levels.Moderate
Proton Pump Inhibitors (PPIs) like OmeprazoleMay slightly decrease MPA exposure. Clinical significance is uncertain but monitor efficacy.Minor
RifampicinInduces UGT enzymes and possibly P-gp, decreasing MPA plasma concentrations. Dose adjustment of MMF may be needed.Moderate
Live Vaccines (e.g., MMR, Varicella, Yellow Fever)Risk of disseminated infection due to immunosuppression. Contraindicated.Major
SevelamerDecreases MPA Cmax and AUC if taken simultaneously. Administer MMF at least 2 hours before sevelamer.Moderate
Oral ContraceptivesTheoretical risk of decreased contraceptive efficacy due to induction of UGT. Women must use a second, highly effective barrier method.Moderate

🔁 Alternatives to Cellcept (Innovator)

Same composition (Mycophenolate mofetil (360mg)), different brands:

Mycept Mofetyl Renodapt Biorphen