What it's for (Indications)
- Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving kidney, heart, or liver transplants.
- It should be used in combination with other immunosuppressants.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Adults: - Kidney Transplant: 1 g orally twice daily. - Heart Transplant: 1.5 g orally twice daily. - Liver Transplant: 1.5 g orally twice daily. Pediatrics: - Kidney Transplant: 600 mg/m² orally twice daily, with a maximum dose of 2 g daily. Dosage should be reduced or interrupted in the event of neutropenia. Further adjustments for renal impairment may be necessary. Administration requires supervision by a physician experienced in immunosuppressive therapy. |
Safety & Warnings
Common Side Effects
- Common adverse reactions (20% or greater) include diarrhea, leukopenia, infection (with a higher frequency of opportunistic infections), and vomiting.
- Other significant adverse reactions include Embryofetal Toxicity, Lymphomas and Other Malignancies, Serious Infections, Blood Dyscrasias (Neutropenia, Pure Red Cell Aplasia), Gastrointestinal Complications, Acute Inflammatory Syndrome Associated with Mycophenolate Products, and Hypersensitivity Reactions.
Serious Warnings
- Black Box Warning: WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS. 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. Increased risk of development of lymphoma and other malignancies. Increased risk of serious infections.
- Mycophenolate mofetil is associated with significant risks including Embryofetal Toxicity (increased risk of first-trimester pregnancy loss and congenital malformations; counseling for females of reproductive potential is required, and safer treatment options should be considered if available).
- There is an increased risk of developing lymphomas and other malignancies, particularly skin cancer.
- Patients are at increased risk of serious infections, including opportunistic infections, bacterial, viral, and fungal infections, some of which may be fatal.
- Blood dyscrasias such as neutropenia and pure red cell aplasia can occur.
- Gastrointestinal complications are common and can include ulceration, hemorrhage, and perforation.
- An acute inflammatory syndrome associated with mycophenolate products has been reported.
- Hypersensitivity reactions, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid, or any component of the drug product can occur.
- The drug should not be used without the supervision of a physician with experience in immunosuppressive therapy.
- Mycophenolate mofetil capsules should not be used interchangeably with mycophenolic acid delayed-release tablets.
How it Works (Mechanism of Action)
The specific mechanism of action was not provided in the clinical data. Mycophenolate mofetil is generally known as a potent, selective, noncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), thereby inhibiting the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Lymphocytes are critically dependent on this pathway for proliferation, hence its immunosuppressive effects.
Commercial Brands (Alternatives)
No other brands found for this formula.