Product image of Micofenolato De Mofetil Generis (Mycophenolate Mofetil) supplied by GNH India

Micofenolato De Mofetil Generis

Active Ingredient:
Mycophenolate Mofetil
Origin:
EU

Micofenolato De Mofetil Generis (Mycophenolate Mofetil)

Mycophenolate Mofetil, the active ingredient in Micofenolato De Mofetil Generis, is an antimetabolite immunosuppressant presented as an oral formulation for oral use. It is used to prevent acute organ rejection, treat lupus nephritis, and prevent graft‑versus‑host disease.

GNH India supplies Micofenolato De Mofetil Generis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and pharmacies worldwide.

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

Mycophenolate Mofetil is employed in immunosuppressive therapy to reduce lymphocyte activity.

  • Kidney transplantation: helps prevent acute rejection.
  • Heart transplantation: helps prevent acute rejection.
  • Liver transplantation: helps prevent acute rejection.
  • Lupus nephritis: reduces renal inflammation and proteinuria.
  • Graft‑versus‑host disease prophylaxis: lowers incidence after hematopoietic stem cell transplant.

How It Works

  • Mycophenolate Mofetil is a selective inhibitor of inosine monophosphate dehydrogenase (IMPDH), the enzyme responsible for de novo synthesis of guanosine nucleotides. By blocking IMPDH, the drug reduces guanosine triphosphate pools, which limits proliferation of activated T‑ and B‑lymphocytes that rely on this pathway, thereby suppressing the immune response essential for graft rejection and autoimmune activity.

Side Effects

Mycophenolate Mofetil may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: frequent loose stools.
  • Headache: transient cranial discomfort.
  • Infections: increased susceptibility to bacterial, viral or fungal infections.

Serious or Rare Side Effects

  • Leukopenia: significant reduction in white blood cells.
  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Pregnancy loss: risk of fetal malformations and miscarriage.

Precautions & Warnings

When prescribing Mycophenolate Mofetil, clinicians should consider several safety precautions.

  • Monitor blood counts: regular CBC to detect leukopenia.
  • Assess liver function: periodic LFTs for hepatotoxicity.
  • Avoid in pregnancy: contraindicated due to teratogenic risk.
  • Use contraception: effective methods required for both sexes during therapy.
  • Adjust dose in renal impairment: consider reduced clearance.
  • Store at ambient temperature: keep below 25°C in original packaging, protect from moisture.

Avoid Interactions

Mycophenolate Mofetil interacts with several medicines that can alter its exposure or increase toxicity.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: reduce absorption of mycophenolate.
  • Azathioprine: additive bone marrow suppression.
  • Live vaccines: increased risk of infection.

Moderate Interactions (Monitor Closely)

  • Cyclosporine or tacrolimus: may increase mycophenolate levels.
  • Rifampin: decreases mycophenolate exposure.
  • Cholestyramine: may lower drug absorption.

Frequently Asked Questions

Micofenolato De Mofetil Generis, containing Mycophenolate Mofetil, is indicated to prevent acute rejection after kidney, heart or liver transplantation, to treat lupus nephritis, and to reduce the risk of graft‑versus‑host disease following hematopoietic stem cell transplantation.

Mycophenolate Mofetil selectively inhibits the enzyme inosine monophosphate dehydrogenase (IMPDH), which is essential for de novo guanosine nucleotide synthesis. This inhibition limits the proliferation of activated T‑ and B‑lymphocytes, thereby dampening the immune response that can lead to organ rejection or autoimmune kidney damage.

The specific dose of Micofenolato De Mofetil Generis is determined by the prescribing clinician based on the patient’s condition, weight, renal function and other individual factors. Healthcare professionals set the appropriate regimen and adjust it as needed during therapy.

Mycophenolate Mofetil is classified as Pregnancy Category D because it can cause fetal malformations and pregnancy loss. It is contraindicated in pregnant women and should be stopped before conception. Breastfeeding is not recommended, as the drug is excreted in milk and may affect the infant.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Mycophenolate Mofetil differs from calcineurin inhibitors such as cyclosporine or tacrolimus by targeting nucleotide synthesis rather than calcium‑dependent signaling. Compared with azathioprine, it offers more selective inhibition of lymphocyte proliferation and often a lower incidence of certain toxicities, though all agents require careful monitoring for infection and bone‑marrow suppression.

Micofenolato De Mofetil Generis should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product in a dry place and avoid exposure to extreme heat or humidity.

The medication is taken orally, usually as tablets or capsules, with or without food as directed by the prescriber. Patients should follow the dosing schedule provided by their healthcare professional and should not alter the regimen without medical advice.

Serious risks include profound leukopenia or neutropenia, which can predispose to severe infections, hepatotoxicity manifested by elevated liver enzymes or liver injury, and teratogenic effects leading to fetal malformations or miscarriage. Prompt reporting of fever, signs of infection or abnormal laboratory results is essential.

Patients with known hypersensitivity to Mycophenolate Mofetil or any component of the formulation should avoid the product. It is also contraindicated in pregnant women, women planning pregnancy, and in individuals with severe uncontrolled infections. Caution is advised in patients with significant renal or hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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