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

Micofenolato De Mofetilo Aurovitas

Active Ingredient:
Mycophenolate Mofetil
Origin:
EU

Micofenolato De Mofetilo Aurovitas (Mycophenolate Mofetil)

Mycophenolate mofetil, the active ingredient in Micofenolato De Mofetilo Aurovitas, is an antimetabolite immunosuppressant presented as an oral formulation for oral use. It is employed to prevent organ rejection, treat lupus nephritis, and reduce graft‑versus‑host disease risk in appropriate patients.

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

Manufacturer / TM Owner

Aurovitas Spain,s.A.U.

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Indications & Clinical Uses

Mycophenolate mofetil is used in several immunologically mediated conditions, primarily to suppress abnormal lymphocyte activity.

  • Prevention of acute organ rejection: lowers the incidence of graft loss in kidney, heart, liver and other solid‑organ transplants.
  • Treatment of lupus nephritis: helps control renal inflammation and proteinuria in systemic lupus erythematosus.
  • Prevention of graft‑versus‑host disease: reduces the occurrence and severity of GVHD after hematopoietic stem cell transplantation.

How It Works

  • Mycophenolate mofetil is a selective, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). By blocking IMPDH, it reduces guanosine nucleotide synthesis, which is essential for DNA replication in activated T and B lymphocytes, thereby inhibiting their proliferation and dampening the immune response.

Side Effects

Adverse reactions may range from mild to severe and should be monitored during therapy.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: frequent loose stools, may lead to dehydration.
  • Headache: transient cranial discomfort.
  • Abdominal pain: cramping or discomfort in the stomach area.
  • Infections: increased susceptibility to bacterial, viral or fungal infections.

Serious or Rare Side Effects

  • Leukopenia: significant reduction in white blood cell count.
  • Severe infections: opportunistic infections such as Pneumocystis jirovecii pneumonia.
  • Hepatic toxicity: elevated liver enzymes or hepatitis.
  • Malignancy: increased risk of post‑transplant lymphoproliferative disorder.
  • Progressive multifocal leukoencephalopathy (PML): rare demyelinating disease of the central nervous system.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient‑specific risk factors and monitor laboratory parameters.

  • Pregnancy: Category D – avoid use unless benefits outweigh risks.
  • Renal impairment: assess renal function and adjust dose as needed.
  • Hepatic impairment: monitor liver enzymes regularly.
  • Infection risk: screen for latent infections and vaccinate appropriately before treatment.
  • Live vaccines: contraindicated during therapy due to immunosuppression.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mycophenolate mofetil may interact with several concomitant medications, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Live vaccines: may cause severe infection.
  • Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): increase mycophenolate exposure and toxicity.
  • Antacids containing magnesium or aluminum: reduce oral absorption of mycophenolate.
  • Azathioprine: additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Mycophenolic acid formulations: concurrent use may increase adverse effects.
  • High‑dose steroids: may augment immunosuppressive effect.
  • Vaccines (inactivated): monitor immune response efficacy.

Frequently Asked Questions

Micofenolato De Mofetilo Aurovitas, containing mycophenolate mofetil, is prescribed to prevent acute rejection in solid‑organ transplantation, to treat lupus nephritis, and to reduce the risk of graft‑versus‑host disease after hematopoietic stem cell transplantation.

Mycophenolate mofetil selectively and reversibly inhibits the enzyme inosine monophosphate dehydrogenase (IMPDH). This blocks guanosine nucleotide synthesis, a critical step for DNA replication in activated T and B lymphocytes, thereby suppressing their proliferation and dampening the immune response.

The dosage of Micofenolato De Mofetilo Aurovitas is individualized by the prescribing clinician based on the specific indication, patient weight, renal function, and concomitant therapies. Patients should follow the exact regimen provided by their healthcare professional.

Mycophenolate mofetil is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should be avoided during pregnancy unless no safer alternative exists. Breastfeeding is not recommended because the drug is excreted in milk and may harm 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 necessary import documentation.

Compared with calcineurin inhibitors such as tacrolimus or cyclosporine, mycophenolate mofetil offers a different mechanism—IMPDH inhibition—resulting in less nephrotoxicity but a higher incidence of gastrointestinal disturbances and bone‑marrow suppression. It is often used in combination regimens to achieve synergistic immunosuppression while balancing side‑effect profiles.

Store the product at ambient temperature, below 25 °C. Keep it in the original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

The medication is taken orally, usually as whole tablets swallowed with water. It should be taken at the same times each day, and patients are advised not to crush or chew the tablets unless specifically instructed by a healthcare professional.

Serious risks include severe infections due to immunosuppression, leukopenia or other blood dyscrasias, hepatic toxicity, and rare but life‑threatening conditions such as progressive multifocal leukoencephalopathy (PML) and post‑transplant lymphoproliferative disorder. Regular monitoring of blood counts and liver function is essential.

Patients with known hypersensitivity to mycophenolate mofetil or any component of the formulation should avoid the drug. It is also contraindicated in pregnant women unless absolutely necessary, in individuals receiving live vaccines, and in patients with uncontrolled severe infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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