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Faslodex

Brand Name:	Faslodex	Trade Name:	fulvestrant
FDA Approved For:	FASLODEX is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.	Pediatric Use:	The pharmacokinetics of fulvestrant have not been evaluated in pediatric patients.
Carcinogen:	Not discussed in FDA's Product label.	Mutagen:	Not discussed in FDA's Product label.
Manufacturer and/or Distributor:	IPR

Adverse Reactions:

The most commonly reported adverse experiences in the FASLODEX and anastrozole treatment groups, regardless of the investigator’s assessment of causality, were gastrointestinal symptoms (including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back pain, vasodilatation (hot flushes), and pharyngitis. Injection site reactions with mild transient pain and inflammation were seen with FASLODEX and occurred in 8 7% of patients (1% of treatments) given the single 5 mL injection (European Trial) and in 27% of patients (4.6% of treatments) given the 2 x 2.5 mL injections (North American Trial). Table 4 lists adverse experiences reported with an incidence of 5% or greater, regardless of assessed causality, from the two controlled clinical trials comparing the administration of FASLODEX 250 mg intramuscularly once a month with anastrozole 1 mg orally once a day. (See Table) A patient may have more than one adverse event. *All patients on FASLODEX received injections, but only those anastrozole patients who were in the North American study received placebo injections. Other adverse events reported as drug-related and seen infrequently (<1%) include thromboembolic phenomena, myalgia, vertigo, and leukopenia. Vaginal bleeding has been reported infrequently (<1%), mainly in patients during the first 6 weeks after changing from existing hormonal therapy to treatment with FASLODEX. If bleeding persists, further evaluation should be considered. )

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