Anastrozole

ANASTROZOLE TABLETS

Manufacturer: Avet Pharmaceuticals Inc

Score: 145.0

Quick Summary

Anastrozole is a non-steroidal aromatase inhibitor used for the treatment of breast cancer in postmenopausal women. It is indicated for adjuvant treatment of hormone receptor-positive early breast cancer, first-line treatment of 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. The recommended dose is 1 mg once daily, and it can be taken with or without food. Anastrozole is contraindicated in patients with demonstrated hypersensitivity to the drug or any excipient, and it may cause fetal harm when administered to a pregnant woman. Common adverse reactions include hot flashes, asthenia, arthritis, pain, and osteoporosis.

Key Clinical Findings and Indications

Adjuvant treatment of hormone receptor-positive early breast cancer
First-line treatment of 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

Demonstrated hypersensitivity to anastrozole or any excipient

Adverse Reactions

Hot flashes
Asthenia
Arthritis
Pain
Osteoporosis
Fractures
Nausea and vomiting
Rash
Depression
Insomnia
Headache

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

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 of reproductive potential to use effective contraception 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
Anastrozole has been studied in pediatric patients with McCune-Albright Syndrome and progressive precocious puberty

Geriatric Use

In studies 0030 and 0027, about 50% of patients were 65 or older
Patients ≥65 years of age had moderately better tumor response and time to tumor progression than patients < 65 years of age regardless of randomized treatment