Classes
DEA Class; Rx
Common Brand Names; Arimidex
- Antineoplastics, Aromatase Inhibitor
Description
Selective non-steroidal aromatase inhibitor
Used for the treatment of breast cancer in postmenopausal women
Improved disease-free survival compared with tamoxifen as adjuvant therapy for early breast cancer; overall survival was similar
Indications
Breast Cancer
Adjuvant treatment
- Indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
First-line treatment
- Indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
Second-line treatment
- Indicated for treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy
Contraindications
Hypersensitivity
May cause fetal harm or loss; use is contraindicated in women who are or may become pregnant
Adverse Effects
- Hot flashes (12-36%)
- Vasodilation (25-36%)
- Fatigue (19%)
- Mood disturbances (19%)
- Nausea and vomiting (19%)
- Weakness (16-19%)
- Arthritis (17%)
- Pain (17%)
- Arthralgia (2-15%)
- Pharyngitis (14%)
- Depression (13%)
- Hypertension (2-13%)
- Bone pain (11%)
- Increased cough (11%)
- Osteoporosis (11%)
- Rash (8-11%)
- 1-10%
- Accidental injury (10%)
- Back pain (10%)
- Fracture (10%)
- Headache (10%)
- Insomnia (10%)
- Peripheral edema (10%)
- Dyspnea (8-10%)
- Abdominal pain (9%)
Warnings
Increased incidence of ischemic cardiovascular events in women with preexisting ischemic heart disease; use only if benefits greatly outweigh risks
Decreases lumbar spine and total hip bone mineral density; increased risk of fractures and osteoporosis; concurrent use with bisphosphonates may be useful in patients at risk for fractures; follow available guidelines for bone mineral density management in postmenopausal women; patients with preexisting osteopenia are at higher risk for developing osteoporosis
Elevated serum cholesterol reported; monitor closely; use with caution in patients with hyperlipidemias; monitor and manage cholesterol levels with current guidelines for patients with LDL elevations
Affords no clinical benefit to premenopausal women with breast cancer
Increased risk of ischemic cardiovascular events in patients with pre-existing ischemic cardiac disease
Pregnancy and Lactation
Based on findings from animal studies and mechanism of action, therapy may cause fetal harm when administered to pregnant woman; there are no studies on use in pregnant women
There are no data on presence of drug or metabolites in human milk, or effects on breast-fed child or on milk production
Maximum Dosage
1 mg per day PO.
1 mg per day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Anastrozole
tablet
- 1mg