Generic Name and Formulations:
Fulvestrant 50mg/mL; soln for IM inj.

Company:
AstraZeneca Pharmaceuticals

Indications for FASLODEX:
Hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Adult Dose for FASLODEX:
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. Moderate hepatic impairment: 250mg (as one 5mL injection) on days 1, 15, 29, then once per month thereafter.

Children's Dose for FASLODEX:
Not applicable.

Pharmacological Class:
Estrogen receptor antagonist.

Warnings/Precautions:
Bleeding diatheses, thrombocytopenia, or anticoagulant use. Moderate to severe hepatic impairment. Pregnancy (Cat.D; avoid); exclude pregnancy before starting. Nursing mothers: not recommended.

Adverse Reactions:
Inj site pain, GI upset, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, constipation; increased hepatic enzymes, hypersensitivity reactions.

Metabolism:
Hepatic (CYP3A4); 99% protein bound.

Elimination:
Fecal (primarily), renal.

Generic Availability:
NO

How Supplied:
Prefilled syringe kit (2 x 5mL)—1