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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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NEWS HIGHLIGHTS

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

DPP-4 Inhibitors Can Cause Severe Joint Pain, FDA Says
Source: Medscape Diabetes & Endocrinology Headlines [2015.08.28]
However, the pain associated with dipeptidyl peptidase-4 inhibitors for type 2 diabetes goes away once patients stop taking the medicine, according to the agency.
News Alerts

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

DPP-4 Inhibitors Linked to Severe Joint Pain, FDA Warns
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- The agency has identified 33 cases since 2006

Low Back Pain and GI Symptoms on the Swiss Alps
Source: Medscape Gastroenterology Headlines [2015.08.26]
Dr Paget discusses a recent patient of his who presented with a 5-year history of recurrent severe low back pain and gastrointestinal symptoms.
Medscape Rheumatology

Is There Sex After Low Back Pain?
Source: Medscape Orthopaedics Headlines [2015.08.26]
For many people with low back pain, sex is excruciating. But the recommended position for the past 25 years--'side-lying' (ie, 'spooning')--is contraindicated by two new biomechanical studies.
Medscape Orthopedics

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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]
CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.

A comparative study of samarium-153-ethylenediaminetetramethylene phosphonic acid with pamidronate disodium in the treatment of patients with painful metastatic bone cancer. [2003.04]
CONCLUSION: The data showed that the therapeutic efficacy of (153)Sm-EDTPM was higher than that of pamidronate disodium (for pain relief maintained more than 3 weeks) and its incidence of blood toxicity was also higher than that of pamidronate disodium. Copyright 2003 S. Karger AG, Basel

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]
A multicentre trial was organized in China as part of an international coordinated research project to study the efficacy and toxicity of single-dose samarium-153 ethylene diamine tetramethylene phosphonate (EDTMP) as a palliative treatment for painful skeletal metastases... Further studies are needed to identify better ways of determining the appropriate dose in the individual case and the efficacy of treatment.

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. [1998.04]
PURPOSE: To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study... CONCLUSION: A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

Adverse events in the long-term follow-up of patients treated with samarium Sm 153 lexidronam for osseous metastases. [2011.10.01]
CONCLUSIONS: Our observation of new-onset, acute and transient edema and neuropathy after samarium Sm 153 lexidronam and of a relationship between edema and post-samarium Sm 153 lexidronam chemotherapy suggests the need for re-examination of patients in past series or for a prospective investigation with nonhematologic adverse events as a primary endpoint. Copyright (c) 2011 Elsevier Inc. All rights reserved.

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

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

- To determine the time to progression in subjects with breast cancer metastatic to bone

only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT). Secondary objectives:

- To determine the overall survival at one year.

- To determine the efficacy of 153Sm-EDTMP at 6 months.

- To assess pain in subjects treated with 153Sm-EDTMP.

- To determine the safety of 153Sm-EDTMP.

Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma [Recruiting]
The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.

Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer [Recruiting]
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.

Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer [Completed]
The primary objective of the study is to determine a recommended phase II dose (RP2D). The secondary objective of the study are: 1. To evaluate preliminary incidence and duration of clinical benefits as determined by improvements of pain, PSA decline and bone scan changes. 2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination with Samarium 153 in patients with advanced, hormone refractory prostate cancer metastatic to the bone.

Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma [Completed]
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.

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Page last updated: 2015-08-28

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