Mycophenolate 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 , Use in Special Populations ].
- Increased risk of development of lymphoma and other malignancies, particularly of the skin[see Warnings and Precautions ].
- 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 ].
Warnings and Precautions (5.8) ……………………………………….05/2025
Mycophenolate mofetil capsules (MMF) are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
Mycophenolate Mofetil Capsules, USP are available in the following strength:
250 mg | hard gelatin capsules with a light blue opaque cap and a bright orange opaque body, filled with a white to off-white powder with small agglomerates; imprinted with "TEVA" on the cap and "7334" on the body |
Mycophenolate mofetil capsules are contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product
The following adverse reactions are discussed in greater detail in other sections of the label:
Embryofetal Toxicity
[see Warnings and Precautions ]Lymphomas and Other Malignancies
[see Warnings and Precautions 5.2)]Serious Infections
[see Warnings and Precautions ]Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia
[see Warnings and Precautions ]Gastrointestinal Complications
[see Warnings and Precautions ]Acute Inflammatory Syndrome Associated with Mycophenolate Products
[see Warnings and Precautions ]Hypersensitivity Reactions
[see Warnings and Precautions ()]5.8 Hypersensitivity ReactionsPostmarketing cases of hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with mycophenolate mofetil capsules. These reactions generally occurred within hours to the next day after initiating mycophenolate mofetil capsules. If signs or symptoms of hypersensitivity reaction occur, discontinue mycophenolate mofetil capsules; treat and monitor until symptoms resolve[see Contraindications (4)].