Difference between revisions of "Tamoxifen (Nolvadex)"

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==General information==
 
==General information==
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Class/mechanism: <ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf Tamoxifen (Nolvadex) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/tamoxifen.pdf Tamoxifen (Nolvadex) package insert (locally hosted backup)]</ref>
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Class/mechanism: SERM (selective estrogen receptor modulator), with estrogen agonist/antagonist properties depending on tissue type. Tamoxifen has estrogen antagonist properties in breast tissue. It has estrogen agonist properties in bone, helping to decrease bone resorption, but in contrast to [[Raloxifene (Evista)]], it also has agonist properties in uterine tissue.<ref name="insert">[http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf Tamoxifen (Nolvadex) package insert]</ref><ref>[[:File:Tamoxifen.pdf | Tamoxifen (Nolvadex) package insert (locally hosted backup)]]</ref>
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<br>Route: TBD
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<br>Route: PO
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<br>Extravasation: TBD
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<br>Extravasation: n/a
  
−
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 package insert<ref name="insert"></ref>.
+
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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==Diseases for which it is used==
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*[[Breast cancer]]
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**[[Breast cancer, ER-positive|ER+ breast cancer]]
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**[[Breast cancer, ER and HER2 co-expressing|ER+/HER2+ breast cancer]]
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*[[Endometrial cancer]]
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*[[Hereditary hemorrhagic telangiectasia]]
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*[[Low-grade serous ovarian cancer]]
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==Diseases for which it was used==
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*[[Hepatocellular carcinoma - historical |Hepatocellular carcinoma]]
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*[[Melanoma - historical|Melanoma]]
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*[[Ovarian cancer - historical|Ovarian cancer]]
  
 
==Patient drug information==
 
==Patient drug information==
−
*[http://chemocare.com/bio/tamoxifen.aspTamoxifen (Nolvadex) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/tamoxifen.aspTamoxifen (Nolvadex) patient drug information (Chemocare)]</ref>
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*[http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf#page=32 Tamoxifen (Nolvadex) package insert PDF pages 32-37]<ref name="insert"></ref>
 +
*[https://chemocare.com/druginfo/Tamoxifen.aspx Tamoxifen (Nolvadex) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Tamoxifen.aspx Tamoxifen (Nolvadex) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/tamoxifen-patient-drug-information Tamoxifen (Nolvadex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/tamoxifen-patient-drug-information Tamoxifen (Nolvadex) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/tamoxifen-patient-drug-information Tamoxifen (Nolvadex) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/tamoxifen-patient-drug-information Tamoxifen (Nolvadex) patient drug information (UpToDate)]</ref>
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 +
==History of changes in FDA indication==
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* 1977-12-30: Initial FDA approval
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* Uncertain date: Approved for the treatment of node-positive [[breast cancer]] in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. ''(Based on ECOG 1178, Hubay et al. 1980, NATO, NCIC-CTG MA.4, NSABP B-09, NSABP B-14)''
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* Uncertain date: Approved for the treatment of metastatic [[breast cancer]] in women and men. Available evidence indicates that patients whose tumors are [[Biomarkers#ER|estrogen receptor]] [[Biomarkers#Expression|positive]] are more likely to benefit from NOLVADEX therapy. ''(Based on Crump et al. 1997)''
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* 1989-03-16: Approved for use in premenopausal women with metastatic [[breast cancer]] as an alternative to oophorectomy or ovarian radiation. ''(Based on Buchanan et al. 1986, Crump et al. 1997, Ingle et al. 1986a)''
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* 1998-10-29: Approved to reduce the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for [[breast cancer]].
 +
* 1998-10-29: Approved to reduce the incidence of breast cancer in women at high risk for breast cancer.
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==History of changes in EMA indication==
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*1974-04-29: EURD
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==Also known as==
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*'''Code name:''' ICI-46474
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*'''Generic names:''' TAM, tamoxifen citrate, TMX
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*'''Brand names:''' Istubal, Nolvadex, Soltamox, Valodex
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Oral medications]]
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[[Category:Protein expression-specific medications]]
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[[Category:Selective estrogen receptor modulators]]
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[[Category:Breast cancer medications]]
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[[Category:Endometrial cancer medications]]
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[[Category:Hereditary hemorrhagic telangiectasia medications]]
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[[Category:Low-grade serous ovarian cancer medications]]
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[[Category:Hepatocellular carcinoma medications (historic)]]
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[[Category:Melanoma medications (historic)]]
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[[Category:Ovarian cancer medications (historic)]]
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[[Category:FDA approved in 1977]]
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[[Category:EMA approved in 1974]]
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[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 00:03, 3 September 2023

General information

Class/mechanism: SERM (selective estrogen receptor modulator), with estrogen agonist/antagonist properties depending on tissue type. Tamoxifen has estrogen antagonist properties in breast tissue. It has estrogen agonist properties in bone, helping to decrease bone resorption, but in contrast to Raloxifene (Evista), it also has agonist properties in uterine tissue.[1][2]
Route: PO
Extravasation: n/a

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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Diseases for which it was used

Patient drug information

History of changes in FDA indication

  • 1977-12-30: Initial FDA approval
  • Uncertain date: Approved for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. (Based on ECOG 1178, Hubay et al. 1980, NATO, NCIC-CTG MA.4, NSABP B-09, NSABP B-14)
  • Uncertain date: Approved for the treatment of metastatic breast cancer in women and men. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from NOLVADEX therapy. (Based on Crump et al. 1997)
  • 1989-03-16: Approved for use in premenopausal women with metastatic breast cancer as an alternative to oophorectomy or ovarian radiation. (Based on Buchanan et al. 1986, Crump et al. 1997, Ingle et al. 1986a)
  • 1998-10-29: Approved to reduce the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for breast cancer.
  • 1998-10-29: Approved to reduce the incidence of breast cancer in women at high risk for breast cancer.

History of changes in EMA indication

  • 1974-04-29: EURD

Also known as

  • Code name: ICI-46474
  • Generic names: TAM, tamoxifen citrate, TMX
  • Brand names: Istubal, Nolvadex, Soltamox, Valodex

References

  1. ↑ 1.0 1.1 1.2 Tamoxifen (Nolvadex) package insert
  2. ↑ Tamoxifen (Nolvadex) package insert (locally hosted backup)
  3. ↑ Tamoxifen (Nolvadex) patient drug information (Chemocare)
  4. ↑ Tamoxifen (Nolvadex) patient drug information (UpToDate)
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