New Indication for Faslodex
August 25, 2017 – The U.S. FDA has approved a new indication for Faslodex® (fulvestrant) injection, manufactured by AstraZeneca, as a single agent for the treatment of post-menopausal patients who have hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, but who have not yet received endocrine therapy. In a clinical trial, patients who were treated with Faslodex, an estrogen-receptor blocker, had average progression-free survival rates approximately three months longer than patients who were treated with Arimidex® (anastrozole), an oral aromatase inhibitor, also manufactured by AstraZeneca. Recommended dosing for Faslodex is 500mg delivered by intramuscular injection on days 1, 15, and 29, then once a month thereafter. The 500mg dose should be divided into two separate injections and delivered slowly, over the course of 1-2 minutes per injection. Patients with moderate hepatic impairment can receive a reduced dosage of 250mg as a single injection on the same schedule.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.