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Breast cancer
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Generic Name and Formulations:

Fulvestrant 50mg/mL; soln for IM inj.

Select therapeutic use:

Indications for FASLODEX:

Hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. In combination with palbociclib: HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.


Give by IM inj slowly (1–2 mins/injection). 500mg (as two 5mL injections, one in each buttock) on Days 1, 15, 29, then once per month thereafter. For combination therapy: give with palbociclib 125mg daily with food for 21 days, followed by 7 days off; in pre/perimenopausal women: also treat with LHRH agonists. Moderate hepatic impairment: 250mg (as one 5mL injection) on Days 1, 15, 29, then once per month thereafter. Other dose modification: see full labeling.


Not established.


Bleeding diatheses, thrombocytopenia, or anticoagulant use. Moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Pregnancy: do testing within 7 days prior to initiating; use effective contraception during therapy and for 1 year after last dose. Nursing mothers: not recommended (during therapy and for 1 year after last dose).


May interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.

Pharmacological Class:

Estrogen receptor antagonist.

Adverse Reactions:

Inj site pain, nausea, vomiting, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, constipation; increased hepatic enzymes, hypersensitivity reactions.


Hepatic (CYP3A4); 99% protein bound.


Fecal (primarily), renal.

Generic Availability:


How Supplied:

Prefilled syringe kit (2 x 5mL)—1

FASLODEX 5ml of 50mg/ml syringes (Qty:2)

appx. price $1906.00