Mycophenolate mofetil, Mycophenolate sodium
Embryofetal Toxicity, Malignancies, and Serious Infections
Experienced Personnel, Equipped Facility
- Only physicians experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients should prescribe mycophenolate.
- Patients receiving this drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
- The physician responsible for maintenance therapy should have complete information needed for patient follow-up.
Immunosuppression and Risk of Malignancies and Serious Infection
- Increased eisk of development of lymphoma and other malignancies, particularly of the skin. For patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.
- 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.
- Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congeintal malformations. Avoid if safer treatment options are available.
- Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning (See Warnings and Precautions)
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- See product information for specific instructions
FDA and Industry Communications
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information