Skip to content

Fulvestrant

    DEA Class; Rx

    Common Brand Names; Faslodex

    • Antineoplastics, Estrogen Receptor Antagonist

    Estrogen-receptor antagonist without any known estrogen agonist effects
    Used in postmenopausal women as monotherapy or in combination with ribociclib for first- and second-line treatment of HR-positive, HER2-negative advanced breast cancer, and in combination with palbociclib or abemaciclib in women with HR-positive, HER2-negative advanced or metastatic breast cancer after disease progression following endocrine therapy
    May interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels

    Advanced Breast Cancer

    Monotherapy

    • Indicated for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative in postmenopausal women not previously treated with endocrine therapy
    • Indicated for HR-positive in postmenopausal women with disease progression following endocrine therapy

    Combination therapy with palbociclib or abemaciclib

    • Indicated HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy
    • Continue until disease progression or unacceptable toxicity
    • Pre/perimenopausal women treated with the palbociclib/abemaciclib combination should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards

    Combination with ribociclib

    • Indicated HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib

    Hypersensitivity to fulvestrant or any component of formulation

    • Nausea (26%)
    • Asthenia (23%)
    • Pain (19%)
    • Vasodilatation (18%)
    • Pharyngitis (16%)
    • HA (15%)
    • Back pain (14%)
    • Constipation (13%)
    • Vomiting (13%)
    • Abd pain (12%)
    • Diarrhea (12%)
    • Inj site pain (11%)
    • Cough (10%)
    • Anorexia (9%)
    • Peripheral edema (9%)
    • Chest pain (7%)
    • Flu-like syndrome (7%)
    • Rash (7%)
    • Depression (6%)
    • Fever (6%)
    • UTI (6%)
    • Anemia (5%)

    Based on findings from animal studies and its mechanism of action, fulvestrant can cause fetal harm when administered to a pregnant woman

    Excretion in human milk unknown

    Pregnancy Category: X

    Lactation: Excretion in milk unknown; because of potential for serious adverse reactions in breast-fed infants, advise women not to breastfeed during treatment and for 1 month after final dose

    Adults

    500 mg IM.

    Elderly

    500 mg IM.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Fulvestrant

    injectable solution

    • 250mg/5mL