Important Safety Information

QUADRAMET^® causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after QUADRAMET, and tended to return to pretreatment levels by 8 weeks.

Before QUADRAMET is administered, consideration should be given to the patient's current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. 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 clinical or laboratory findings suggesting DIC. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefits of the treatment outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.

Patients who receive QUADRAMET should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours following administration. Whenever possible, a toilet should be used, rather than a urinal, and the toilet should be flushed several times after each use. Spilled urine should be cleaned up completely and patients should wash their hands thoroughly. If blood or urine gets onto clothing, the clothing should be washed separately, or stored for 1-2 weeks to allow for decay of the Sm-153. Some patients have reported a transient increase in bone pain shortly after injection (flare reaction). This is usually mild and self-limiting and occurs within 72 hours of injection. Such reactions are usually responsive to analgesics.

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.
Adverse Reactions: The most frequent events are leukopenia, thrombocytopenia, and spinal cord compression in patients with cervical, thoracic, or lumbar spine metastases.