Mycophenolic acid - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS New or Reactivated Viral Infections: Consider reducing immunosuppression.

Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatment interruption or dose reduction.

Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease.

Hypersensitivity Reactions: Discontinue Myfortic; treat and monitor until signs and symptoms resolve.

Immunizations: Avoid live attenuated vaccines.

Patients with Hereditary Deficiency of Hypoxanthine-guanine Phosphoribosyl-transferase (HGPRT): May cause exacerbation of disease symptoms; avoid use.

Blood Donation: Avoid during therapy and for 6 weeks thereafter.

Semen Donation: Avoid during therapy and for 90 days thereafter.

5.1 Embryo-Fetal Toxicity Use of mycophenolic acid delayed-release tablets during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities, including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.

Females of reproductive potential must be aware of these risks and must be counseled regarding pregnancy prevention and planning.

Avoid use of mycophenolic acid delayed-release tablets during pregnancy if safer treatment options are available [ see Use in Specific Populations ( 8.1 , 8.3 )].

5.2 Management of Immunosuppression Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid delayed-release tablets.

Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

The physicians responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Boxed Warning ].

5.3 Lymphoma and Other Malignancies Patients receiving immunosuppressants, including mycophenolic acid delayed-release tablets, are at increased risk of developing lymphomas and other malignancies, particularly of the skin [see Adverse Reactions ].

The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.

As usual 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.

Post-transplant lymphoproliferative disorder (PTLD) has been reported in immunosuppressed organ transplant recipients.

The majority of PTLD events appear related to Epstein-Barr Virus (EBV) infection.

The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children.

5.4 Serious Infections Patients receiving immunosuppressants, including mycophenolic acid delayed-release tablets, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, and new or reactivated viral infections, including opportunistic infections [see Warnings and Precautions ].

These infections may lead to serious, including fatal outcomes.

Because of the danger of oversuppression of the immune system which can increase susceptibility to infection, combination immunosuppressant therapy should be used with caution.

5.5 New or Reactivated Viral Infections Polyomavirus associated nephropathy (PVAN), JC virus-associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV), SARS-CoV-2 infection, have been reported in patients treated with immunosuppressants, including MPA derivatives mycophenolic acid and MMF.

Reduction in immunosuppression should be considered for patients who develop evidence of new or reactivated viral infections.