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Quadramet is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radonuclide bone scan More

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REFERENCES:

1. Serafini AN, Houston SJ, Resche I, et al. Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. J Clin Oncol. 1998;16:1574-1581.
2. Sartor O, Reid RH, Hoskin PJ, et al. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004;63:940-945.
3. Serafini AN, Houston SJ, Resche I, et al. Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. J Clin Oncol. 1998;16:1574-1581.
4. Quadramet^® (Samarium Sm 153 Lexidronam Injection) prescribing information. April 2009.

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.

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