Important Safety Information
Anastrozole is FDA-approved for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer, and treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
Anastrozole is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria.
Important
Non-Medical Use
Anastrozole has no approved indication for bodybuilding or performance enhancement. Non-medical use falls outside approved indications and carries health risks including bone mineral density loss, arthralgia, dyslipidemia, and cardiovascular risk. Product strength and laboratory verification do not establish safety for non-medical use.
Potential Adverse Effects
Bone effects: Patients receiving anastrozole had a mean decrease in both lumbar spine and total hip bone mineral density compared to baseline in the ATAC trial. Bone mineral density monitoring is recommended.
Cardiovascular effects: In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with anastrozole (17% vs 10% on tamoxifen).
Cholesterol: More patients receiving anastrozole were reported to have elevated serum cholesterol compared to tamoxifen (9% vs 3.5%).
Common adverse reactions: Hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema, and lymphedema.
Embryo-fetal toxicity: Based on findings from animal studies and its mechanism of action, anastrozole can cause fetal harm when administered to a pregnant woman.
Conditions Requiring Medical Evaluation
Anastrozole should be used with caution in patients with pre-existing ischemic heart disease due to increased incidence of ischemic cardiovascular events. Bone mineral density monitoring is recommended. Pregnancy status should be verified prior to initiation of anastrozole in females of reproductive potential.
Monitoring During Therapy
Medically supervised anastrozole therapy involves monitoring for adverse effects including bone mineral density changes, cholesterol levels, and cardiovascular events. No dosage adjustment is necessary for patients with renal impairment or for elderly patients. No changes in dose are recommended for patients with mild-to-moderate hepatic impairment.
Product Care
Storage & Handling
Store in a cool, dry place away from direct light and moisture. Keep the product in its original packaging and out of the reach of children.
Further Safety Information