Anastrozole

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

General Guidance

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

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