MycoTero® 500 mg / MycoTero-S® 360 mg Tablets (Mycophenolate Mofetil)

Manufactured by Hetero Healthcare

1. Indications and Usage

   MycoTero® / MycoTero-S® are immunosuppressive agents indicated for the prophylaxis of organ rejection in adult and pediatric recipients (≥3 months of age) of:

   • Kidney transplants
   • Heart transplants
   • Liver transplants

   These medications should be used in combination with other immunosuppressive agents, such as cyclosporine and corticosteroids.

2. Pharmacology

   • Mechanism: MMF is converted to MPA, which inhibits IMPDH, suppressing T/B lymphocyte proliferation and antibody formation, reducing graft rejection when combined with corticosteroids or calcineurin inhibitors.
   • PK Highlights: Rapid absorption (~94% bioavailability), hepatic metabolism → glucuronidation, renal excretion.
   • PD: Dose-dependent lymphocyte suppression; additive effect with corticosteroids and calcineurin inhibitors

3. Dosage and Administration

   Adults:

   • Renal transplant: 1 g orally twice daily (total 2 g/day) – can adjust to 500 mg or 360 mg formulations as needed.
   • Cardiac transplant: 1.5 g orally twice daily (total 3 g/day).
   • Hepatic transplant: 1.5 g orally twice daily (total 3 g/day).

   Pediatrics (≥3 months):

   • Renal transplant: 600 mg/m² orally twice daily, max 2 g/day.

4. Adverse Reactions

   • Common: Diarrhea, nausea, vomiting, leukopenia, anemia
   • Serious: Sepsis, lymphoma, gastrointestinal hemorrhage
   • Others: Hypertension, hyperglycemia, hypokalemia

5. Drug Interactions

   • Cyclosporine: Concomitant use may alter mycophenolate mofetil (MMF) levels; monitor for potential toxicity.
   • Antacids / Proton Pump Inhibitors (PPIs): ICo-administration can reduce MMF absorption. Administer MMF at least 2 hours apart from antacids or PPIs.
   • Acyclovir / Ganciclovir: Concurrent use may increase plasma concentrations of both MMF and acyclovir/ganciclovir. Monitor for potential adverse effects.
   • Oral Contraceptives: MMF may decrease the efficacy of oral contraceptives. Advise patients to use alternative or additional contraception methods.

6. Contraindications

   • Hypersensitivity to mycophenolate mofetil, mycophenolic acid, or any excipients.
   • Pregnancy: Mycophenolate mofetil can cause fetal harm. It is contraindicated in pregnant women unless no suitable alternative exists.
   • Breastfeeding: Mycophenolate mofetil is contraindicated in nursing mothers.
   • Pediatrics: Safety ≥3 months in renal transplant
   • Geriatrics: Monitor infection risk
   • Renal conditions: Adjust the dose

7. Warnings and Precautions

   • Embryo-Fetal Toxicity: Mycophenolate mofetil can cause fetal harm. Effective contraception is required before, during, and after therapy.
   • Infections: Increased susceptibility to bacterial, viral, fungal, and protozoal infections.
   • Malignancies: Increased risk of lymphoma and skin cancer.
   • Hematologic Effects: Monitor for neutropenia, anemia, and thrombocytopenia.
   • Gastrointestinal Effects: Nausea, vomiting, and diarrhea may occur.
   • Vaccinations: Avoid live vaccines during therapy.

8. Overdose

   • Symptoms: GI toxicity, leukopenia, anemia, thrombocytopenia
   • Management: Supportive care, monitor CBC, temporary drug discontinuation, not dialyzable
   • Severe neutropenia: Consider hematopoietic growth factors under supervision

9. Storage and Handling

   • Store at < 25°C in a dry place, protected from light.
   • Keep out of reach of children.

10. Packaging

    • MycoTero® 500 mg: Blister packs of 10, 30, 100 tablets.
    • MycoTero-S® 360 mg: Blister packs of 10, 30, 100 tablets.

Note: This information is intended for healthcare professionals. For complete prescribing information, refer to the official package insert provided by Hetero Healthcare.