ANASTROZOLE

Manufacturer: AvPAK

Score: 141.0

Quick Summary

Anastrozole is a non-steroidal aromatase inhibitor used in the treatment of breast cancer in postmenopausal women. It works by lowering estrogen levels in the body, which can help slow or stop the growth of hormone-receptor-positive breast cancer. The drug is indicated 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. Common side effects include hot flashes, asthenia, arthritis, pain, and osteoporosis. Anastrozole is contraindicated in patients with demonstrated hypersensitivity to the drug or any of its excipients.

Key Clinical Findings and Indications

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
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy

Important Safety Information

Warning

Anastrozole may cause fetal harm when administered to a pregnant woman

Contraindications

Hypersensitivity to the drug or any of its excipients

Adverse Reactions

Hot flashes
Asthenia
Arthritis
Pain
Osteoporosis
Fractures
Back pain
Insomnia
Headache
Peripheral edema
Increased cough
Dyspnea
Pharyngitis

Dosing Recommendations

General Guidance

No dose adjustment is necessary for patients with renal impairment or for elderly patients

Hormone receptor-positive early breast cancer

Adult Dose

1 mg once daily

Pediatric Dose

Not recommended

Hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

Adult Dose

1 mg once daily

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

Anastrozole may cause fetal harm when administered to a pregnant woman
Advise pregnant women and females of reproductive potential of the potential risk to a fetus

Nursing Mothers

It is not known whether anastrozole is excreted in human milk
Advise females not to breastfeed during treatment with anastrozole

Pediatric Use

The efficacy of anastrozole in the treatment of pubertal gynecomastia in adolescent boys and in the treatment of precocious puberty in girls with McCune-Albright Syndrome has not been demonstrated
The safety and effectiveness of anastrozole in pediatric patients have not been established

Geriatric Use

The pharmacokinetics of anastrozole are not affected by age
In studies 0030 and 0027, about 50% of patients were 65 or older

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