WARNING

IT IS RECOMMENDED THAT MITHRACIN (plicamycin) BE ADMINISTERED ONLY TO HOSPITALIZED PATIENTS BY OR UNDER THE SUPERVISION OF A QUALIFIED PHYSICIAN WHO IS EXPERIENCED IN THE USE OF CANCER CHEMOTHERAPEUTIC AGENTS, BECAUSE OF THE POSSIBILITY OF SEVERE REACTIONS. FACILITIES FOR THE DETERMINATION OF NECESSARY LABORATORY STUDIES MUST BE AVAILABLE.

SEVERE THROMBOCYTOPENIA, A HEMORRHAGIC TENDENCY AND EVEN DEATH MAY RESULT FROM THE USE OF MITHRACIN (plicamycin) . ALTHOUGH SEVERE TOXICITY IS MORE APT TO OCCUR IN PATIENTS WHO HAVE FAR-ADVANCED DISEASE OR ARE OTHERWISE CONSIDERED POOR RISKS FOR THERAPY, SERIOUS TOXICITY MAY ALSO OCCASIONALLY OCCUR EVEN IN PATIENTS WHO ARE IN RELATIVELY GOOD CONDITION.

IN THE TREATMENT OF EACH PATIENT, THE PHYSICIAN MUST WEIGH CAREFULLY THE POSSIBILITY OF ACHIEVING THERAPEUTIC BENEFIT VERSUS THE RISK OF TOXICITY WHICH MAY OCCUR WITH MITHRACIN (plicamycin) THERAPY. THE FOLLOWING DATA CONCERNING THE USE OF MITHRACIN (plicamycin) IN THE TREATMENT OF TESTICULAR TUMORS, HYPERCALCEMIC AND/OR HYPERCALCIURIC CONDITIONS ASSOCIATED WITH VARIOUS ADVANCED MALIGNANCIES, SHOULD BE THOROUGHLY REVIEWED BEFORE ADMINISTERING THIS COMPOUND.