Selected Important Risk Information About Quadramet®
Contraindications: Quadramet is contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds
Warnings and Precautions: Quadramet causes bone marrow suppression. Before administered, the patient's current clinical, hematological status, and bone marrow response history to myelotoxic agents should be considered. Metastatic prostate and other cancers can be associated with disseminated intravascular coagulation (DIC); caution should be exercised in treating cancer patients whose platelet counts are falling or who have other findings suggesting DIC. Blood counts should be monitored weekly for at least 8 weeks or until bone marrow recovery.
The potential for additive bone marrow toxicity of Quadramet with chemotherapy or external beam radiation has not been studied. Quadramet should not be administered concurrently with either of these treatments unless the benefits outweigh the risks and adequate marrow recovery has occurred.
Quadramet can cause fetal harm. Women of childbearing potential should be advised to avoid becoming pregnant soon after receiving Quadramet. If administered, pregnant patients should be appraised of the potential hazard to the fetus and the potential for serious adverse reactions in nursing infants.
QUADRAMET®, like other radioactive drugs,must be handled with care, and appropriate safety measures must be taken to minimize radiation exposure of clinical personnel and others in the patient environment.
Adverse Reactions: The most frequent events are leukopenia, thrombocytopenia, and spinal cord compression in patients with cervical, thoracic, or lumbar spine metastases.