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Quadramet^® Publications

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Quadramet^® Publications Highlights:

Samarium-153-lexidronam Complex for Treatment of Painful Bone Metastases in Hormone-Refractory Prostate Cancer (PDF 265KB)

- Sartor O, Reid RH, Hoskin PJ, et al. Urology. 2004;63:940-945

The results of this study demonstrated that Samarium-153-lexidronam (153Sm-lexidronam) is safe and effective for the relief of the pain of bone metastases in patients with hormone-refractory prostate cancer.

Safety and Efficacy of Repeat Administration of Samarium Sm-153 Lexidronam to Patients With Metastatic Bone Pain (PDF 191KB)

- Sartor O, Reid RH, Bushnell DL, et al. Cancer. 2007;109:637-643.

Repeated administration of Sm-153 is both efficacious and well tolerated in the treatment of bone pain and adverse events did not increase with repeat dosing of Sm-153.

Palliation of Pain Associated With Metastatic Bone Cancer Using Samarium-153 Lexidronam: A Double-Blind Placebo-Controlled Clinical Trial (PDF 193KB)

- Serafini AN, Houston SJ, Resch I, et al. J Clin Oncol. 1998;16:574-1581.

A single intravenous dose of 1.0 mCi/kg of 153Sm-EDTMP provided efficacy with relatively mild and reversible hematologic effects in patients with pain associated with bone metastases.

A Dose-Controlled Study of ¹⁵³Sm-Ethylenediaminetetramethylenephosphonate (EDTMP) in the Treatment of Patients With Painful Bone Metastases (PDF 167KB)

- Resche I, Chatal J-F, Pecking A, et al. Eur J Cancer. 1997;33:1583-1591.

The 1.0 mCi/kg dose was found to be safe and effective for the treatment of painful bone metastases. Excellent efficacy and well-defined toxicity may make 153Sm-EDTMP appropriate for use in earlier stages of treatment of metastases.

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REFERENCES:

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.

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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.