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 (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)].
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 for oral suspension is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
Mycophenolate mofetil for oral suspension, USP is available as 35 g mycophenolate mofetil white to off-white powder for reconstitution (200 mg/mL upon reconstitution).
Mycophenolate mofetil is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product
Postmarketing cases of hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with mycophenolate mofetil. These reactions generally occurred within hours to the next day after initiating mycophenolate mofetil. If signs or symptoms of hypersensitivity reaction occur, discontinue mycophenolate mofetil; treat and monitor until symptoms resolve
The following adverse reactions are discussed in greater detail in other sections of the label:
- Embryofetal Toxicity [see Warnings and Precautions (5.1)]
- Lymphomas and Other Malignancies [see Warnings and Precautions 5.2)]
- Serious Infections [see Warnings and Precautions (5.3)]
- Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4)]
- Gastrointestinal Complications [see Warnings and Precautions (5.5)]
- Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7)]
- Hypersensitivity Reactions [see]
5.8 Hypersensitivity ReactionsPostmarketing cases of hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with mycophenolate mofetil. These reactions generally occurred within hours to the next day after initiating mycophenolate mofetil. If signs or symptoms of hypersensitivity reaction occur, discontinue mycophenolate mofetil; treat and monitor until symptoms resolve
[see Contraindications (4)].