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FASLODEX: an oestrogen receptor antagonist with no known agonist effects

Offers effective disease control with a well established tolerability profile

FASLODEX (fulvestrant) is a steroidal analogue of 17β-oestradiol structurally different from tamoxifen.1

FASLODEX has a high affinity for the oestrogen receptor (ER). Compared with oestradiol the relative in vitro ER-binding affinity of FASLODEX is 89% versus 2.5% for tamoxifen.1 The molecular effects of FASLODEX are also different than those of the selective oestrogen receptor modulator (SERM) tamoxifen: fulvestrant totally inactivates ER-regulated transcription, while tamoxifen leads to a partial inactivation.1

 

 Read more about the mechanism of action of FASLODEX (fulvestrant)

FASLODEX 500 mg or FASLODEX 250 mg (depending on the country) is indicated for the treatment of postmenopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen.2

There may be local variations in the approved label, so please consult your local prescribing information before use.

Download the FASLODEX Summary of Product Characteristics

FASLODEX: approval status

FASLODEX 250 mg was first approved in 2002 in the United States3. As of 16 March 2010, FASLODEX 500 mg became the approved monthly dose in over 29 countries4, and as of 13 September 2010, it became the approved dose in the US3. FASLODEX 500 mg is also the approved dose in Japan. FASLODEX 250 mg monthly remains the approved dose in the rest of world.4

References

  1. Possinger K. Fulvestrant—a new treatment for postmenopausal women with hormone-sensitive advanced breast cancer. Expert Opin Pharmacother 2004; 5(12): 2549–58.
  2. FASLODEX Summary of Product Characteristics. Document available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000540/WC500021174.pdf. Accessed 12 August 2015.
  3. US Food and Drug Administration. FASLODEX drug label information. Last updated: Nov 2012. Document available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo. Accessed 12 August 2015.
  4. AstraZeneca, Data on file; FDX1211101.