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Check Drug InteractionsMycophenolate Mofetil Prescribing Information
- Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning[see Warnings and Precautions (5.1), Use in Special Populations (8.1,8.3)].
- Increased risk of development of lymphoma and other malignancies, particularly of the skin[see Warnings and Precautions (5.2)].
- Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes[see Warnings and Precautions (5.3)].
| Indications and Usage, Pediatric Heart or Liver Transplants (1)………………………………………… | 6/2022 |
| Dosage and Administration, Dosage Recommendations for Heart Transplant Patients (2.3) ……………………………………………………………………………………………………………. | 6/2022 |
| Dosage and Administration, Dosage Recommendations for Liver Transplant Patients (2.4) …………………………………………………………………………………………………………….. | 6/2022 |
| Warnings and Precautions, Serious Infections (5.3) ……………………………………………………... | 10/2021 |
| Warnings and Precautions, Acute Inflammatory Syndrome Associated with Mycophenolate Products (5.7) ………………………………………………..................................................................................... | 10/2021 |
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
[see Clinical Studies (14.1)]
, heart [see Clinical Studies (14.2)]
or liver transplants [see Clinical Studies (14.3)]
, in combination with other immunosuppressants. ADULTS | DOSAGE |
Kidney Transplant | 1 g twice daily, orally (2.2) |
Heart Transplant | 1.5 g twice daily orally (2.3) |
Liver Transplant | 1.5 g twice daily orally (2.4) |
PEDIATRICS | |
Kidney Transplant | 600 mg/m2 twice daily, up to maximum of 2 g daily (2.2) |
Heart Transplant | 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily (2.3) |
Liver Transplant | 600 mg/m2 orally twice daily (starting dose) up to a maximum of 900 mg/m2 twice daily (2.4) |
- Reduce or interrupt dosing in the event of neutropenia. (2.5)
- See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia (2.5).
Mycophenolate mofetil for tablets and capsules are available in the following dosage forms and strengths:
| Capsules | 250 mg mycophenolate mofetil, white to off-white blend of mycophenolate mofetil filled in size "1" hard gelatin capsule with Ivory Cap and Ivory Body, printed "SAL" on cap and "726" on body in black. |
| Tablets | 500 mg mycophenolate mofetil, pinkish brown colored, capsule shaped, film coated tablet with "SAL" engraved on one side and engraved "725" on other side. |
- Male Patients: Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment (8.3)
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available