Classes
DEA Class; Rx
Common Brand Names; Faslodex
- Antineoplastics, Estrogen Receptor Antagonist
Description
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
Indications
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
Contraindications
Hypersensitivity to fulvestrant or any component of formulation
Adverse Effects
- 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%)
Warnings
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 and Lactation
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
Maximum Dosage
500 mg IM.
500 mg IM.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fulvestrant
injectable solution
- 250mg/5mL
