Difference between revisions of "Samarium-153 (Quadramet)"

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==General information==
 
==General information==
Class/mechanism: Radioactive pharmaceutical agent (Samarium-153) that concentrates in areas of bone turnover associated with hydroxyapatite and releases beta and gamma radiation.  Samarium-153 accumulates in osteoblastic lesions about 5 times as much as normal bone.  Samarium-153's half-life is 46.3 hours.<ref name="insert">[http://www.lantheus.com/assets/quadramet-us-outsert-513145-0114-format-2-3-4-2014.pdf Samarium-153 (Quadramet) package insert]</ref><ref>[[Media:Samarium153a.pdf|Samarium-153 (Quadramet) package insert (locally hosted backup)]]</ref><ref>[http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000150/WC500041751.pdf Samarium-153 (Quadramet) alternative package insert]</ref><ref>[[Media:Samarium153b.pdf|Samarium-153 (Quadramet) alternative package insert (locally hosted backup)]]</ref><ref>[http://www.lantheus.com/products/overview/quadramet/ Quadramet manufacturer's website]</ref>
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Class/mechanism: Radioactive pharmaceutical agent (Samarium-153) that concentrates in areas of bone turnover associated with hydroxyapatite and releases beta and gamma radiation.  Samarium-153 accumulates in osteoblastic lesions about 5 times as much as normal bone.  Samarium-153's half-life is 46.3 hours.<ref name="insert">[http://www.lantheus.com/assets/quadramet-us-outsert-513145-0114-format-2-3-4-2014.pdf Samarium-153 (Quadramet) package insert]</ref><ref>[[:File:Samarium153a.pdf|Samarium-153 (Quadramet) package insert (locally hosted backup)]]</ref><ref>[http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000150/WC500041751.pdf Samarium-153 (Quadramet) alternative package insert]</ref><ref>[[:File:Samarium153b.pdf|Samarium-153 (Quadramet) alternative package insert (locally hosted backup)]]</ref><ref>[http://www.lantheus.com/products/overview/quadramet/ Quadramet manufacturer's website]</ref>
 
<br>Route: IV
 
<br>Route: IV
 
<br>Extravasation: no information
 
<br>Extravasation: no information
  
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
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For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.<ref name="insert"></ref>
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
*3/28/1997: Initial FDA approval "for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan."
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*1997-03-28: Initial approval for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
 
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==History of changes in EMA indication==
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*1998-02-04: Initial authorization
 
==Also known as==
 
==Also known as==
 
*'''Generic names:''' 153-Sm-EDTMP, 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP), lexidronam pentasodium, samarium [153 SM], samarium Sm 153 lexidronam injection
 
*'''Generic names:''' 153-Sm-EDTMP, 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP), lexidronam pentasodium, samarium [153 SM], samarium Sm 153 lexidronam injection
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[[Category:FDA approved in 1997]]
 
[[Category:FDA approved in 1997]]
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[[Category:EMA approved in 1998]]

Latest revision as of 00:14, 6 July 2024

General information

Class/mechanism: Radioactive pharmaceutical agent (Samarium-153) that concentrates in areas of bone turnover associated with hydroxyapatite and releases beta and gamma radiation. Samarium-153 accumulates in osteoblastic lesions about 5 times as much as normal bone. Samarium-153's half-life is 46.3 hours.[1][2][3][4][5]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 1997-03-28: Initial approval for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

History of changes in EMA indication

  • 1998-02-04: Initial authorization

Also known as

  • Generic names: 153-Sm-EDTMP, 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP), lexidronam pentasodium, samarium [153 SM], samarium Sm 153 lexidronam injection
  • Brand name: Quadramet

References