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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 More FASLODEX information

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. Read FASLODEX prescribing information

FASLODEX key studies

Clinical trials have confirmed the efficacy and safety profile of FASLODEX 500 mg and 250 mg More on the key studies

Adverse events should be reported. Please contact your local adverse event reporting authority should your patient experience an adverse event.

While the Internet serves a global community, the pharmaceutical industry is subject to country-specific regulatory considerations. This means that the registration status and approved product labels may not be the same in different countries. Please refer to your local Prescribing Information for full details of products referred to in this website.

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

  1. Di Leo A et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010; 28(30): 4594–600.
  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.