When your patient is a postmenopausal woman with hormone receptor-positive, metastatic breast cancer that has progressed following initial antiestrogen therapy…Go with FASLODEX

New Indication for FASLODEX

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Clinical Trial Data

Review data from the CONFIRM* trial

See FASLODEX® (fulvestrant) Injection efficacy data from the CONFIRM trial

Clinical Trial Data

Review data from the CONFIRM* trial

Dr. Angelo Di Leo

From the Lead Author of CONFIRM 

Dr. Angelo Di Leo discusses the

FASLODEX Mechanism of Action

Get information to consider treating with FASLODEX® (fulvestrant) 500 mg Injection, including information about dosing, administration, and mechanism of action.

For the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer...
FASLODEX is NOW APPROVED for use in combination with palbociclib
1751106-2951300 Last Updated 5/14

Important Safety Information About FASLODEX

  • FASLODEX is contraindicated in patients with known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema have been reported in association with FASLODEX

  • Because FASLODEX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or in patients on anticoagulants

  • FASLODEX is metabolized primarily in the liver. A 250-mg dose is recommended in patients with moderate hepatic impairment. FASLODEX has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C)

  • Fetal harm can occur when administered to a pregnant woman. Women should be advised of the potential hazard to the fetus and to avoid becoming pregnant while receiving FASLODEX

  • The most common, clinically significant adverse reactions occurring in >5% of patients receiving FASLODEX were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation

  • Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX users and were non dose-dependent

Indication For FASLODEX

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Prescribing Information with Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800‑FDA‑1088.

*CONFIRM = COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer.