Table 2.
FDA categories for Immunosuppressive Medicationsa
| Immunosuppressive Medication | FDA Category |
|---|---|
| CNI | |
| cyclosporine (Neoral, Sandimmune, Gengraf) | C |
| tacrolimus, FK506 (Prograf) | C |
| Antiproliferative agents | |
| mycophenolate mofetil (CellCept, Myfortic) | D |
| azathioprine (Imuran) | D |
| rapamycin, sirolimus (Rapamune) | C |
| leflunomide (Arava) | X |
| Corticosteroids | |
| prednisone (Deltazone) | B |
| Antirejection agents | |
| methylprednisolone | C |
| muromonab-CD3 (Orthoclone OKT3) | C |
| anti-thymocyte globulins (Thymoglobulin, ATGAM) | C |
FDA pregnancy categories definitions: A, controlled studies in pregnant women have not demonstrated a risk to the fetus in the first trimester with no evidence of risk in later trimesters; B, either animal-reproduction studies have failed to demonstrate fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the first trimester; C, either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available; D, there is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk; X, studies in animals or humans have demonstrated fetal abnormalities, or there is evidence of fetal risk on the basis of human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit; the drug is contraindicated in women who are or may become pregnant.