Fulvestrant (Faslodex)

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General information

Class/mechanism: Estrogen receptor antagonist; competitively binds to the estrogen receptor (ER) and downregulates estrogen receptor expression.[1][2][3]
Route: IM
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2004-03-09: Initial authorization

History of changes in Health Canada indication

  • 2004-02-17: Initial notice of compliance
  • Uncertain date: Indicated for treatment of estrogen receptor-positive, human epidermal growth receptor 2 (HER2)negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
  • Uncertain date: Indicated as hormonal treatment of locally advanced or metastatic breast cancer in postmenopausal women, regardless of age, who have disease progression following prior anti-estrogen therapy.

History of changes in PMDA indication

  • 2011-09-26: Initial approval for the treatment of postmenopausal breast cancer.
  • 2017-09-27: Revised indication and a new dosage for the treatment of breast cancer.

Also known as

  • Code names: ICI-182780, ZD-9238
  • Brand names: Faslodex, Fasnorm, Fulvenat, Fulvidax, Fuvestrol