Welcome to Faslodex.net
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FASLODEX (fulvestrant)
FASLODEX is indicated for the treatment of postmenopausal women with ER+ 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.
About FASLODEX
FASLODEX is a steroidal analogue of 17β-oestradiol structurally different from tamoxifen.1
Prescribing Information
The dose of FASLODEX has changed from 250 mg intramuscular injection (IM) to 500 mg IM with an additional 500 mg on day 14, as the licensed FASLODEX monthly dose in certain countries.
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FASLODEX key studies
Clinical trials have confirmed the efficacy and safety profile of FASLODEX 500 mg and 250 mg
Adverse events should be reported. Please contact your local adverse event reporting authority should your patient experience an adverse event. For those in the UK, reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to AstraZeneca.
Following the EU approval of FASLODEX 500 mg on March 21st 2010, the approved dose of fulvestrant may have changed from 250 mg monthly to 500 mg monthly.
The recommended dose is 500 mg to be administered intramuscularly as two 5 mL injections, one in each buttock, at intervals of 1 month, with an additional 500 mg dose given 2 weeks after the initial dose. It is recommended that the injection be administered slowly (1-2 minutes/injection). FASLODEX 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
AstraZeneca does not recommend the use of this product outside the product licence.
Please refer to your local approved licence and take this into consideration when viewing the information contained in this website.
References
- Di Leo A et al. Results of theCONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant500 mg in postmenopausal women with estrogen receptor-positive advancedbreast cancer. J Clin Oncol 2010; 28(30): 4594–600.
- FASLODEX UK Summary of Product Characteristics.
- AstraZeneca, data on file; FDX2810101.
- Robertson JF. Fulvestrant (Faslodex®) – How to make a good drug better. Oncologist 2007; 12: 774-84.
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