Quadramet (Samarium SM 153 Lexidronam Pentasodium) - Summary

QUADRAMET SUMMARY

QUADRAMET^® is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET^® is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration. QUADRAMET^® does not contain a preservative. Each milliliter contains 35 mg EDTMP•H₂O, 5.3 mg Ca [as Ca(OH)₂], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.

QUADRAMET^® is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

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QUADRAMET NEWS HIGHLIGHTS

Media Articles Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)

Pain Is In The Eyes Of The Beholder
Source: Pain / Anesthetics News From Medical News Today [2008.11.26]

FDA Approves New Drug To Alleviate Moderate To Severe Pain
Source: Pain / Anesthetics News From Medical News Today [2008.11.26]

Scripps Research Team Defines New Painkilling Chemical Pathway - Discovery Could Lead To New Pain Treatments
Source: Neurology / Neuroscience News From Medical News Today [2008.11.24]

FDA Approves Dual-Action Analgesic for Moderate to Severe Acute Pain
Source: MedPage Today Neurology [2008.11.24]

FDA Approves Tapentadol Immediate-Release Tablets For Relief Of Moderate To Severe Acute Pain
Source: Pain / Anesthetics News From Medical News Today [2008.11.22]

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Published Studies Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)

[Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases] [2005.06]

A comparative study of samarium-153-ethylenediaminetetramethylene phosphonic acid with pamidronate disodium in the treatment of patients with painful metastatic bone cancer. [2003.04]

Multicentre trial on the efficacy and toxicity of single-dose samarium-153-ethylene diamine tetramethylene phosphonate as a palliative treatment for painful skeletal metastases in China. [1999.01]

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. [1998.04]

Myelotoxicity of samarium Sm 153 lexidronam in patients receiving prior treatment with chemotherapy or radiotherapy. [2008.09]

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Clinical Trials Related to Quadramet (Samarium SM 153 Lexidronam Pentasodium)

Samarium Sm 153 Lexidronam Pentasodium and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma [Active, not recruiting]

Samarium Sm 153 Lexidronam Pentasodium Combined With Zoledronic Acid or Pamidronate in Treating Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain [Active, not recruiting]

Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients With Bone Only Metastases [Recruiting]

Samarium Sm 153 Lexidronam Pentasodium With or Without Vaccine Therapy and GM-CSF in Treating Patients With Prostate Cancer and Bone Metastases [Recruiting]

Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer [Recruiting]

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