Anastrozole 1 mg Tablet

Anastrozole is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2 ) Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. …

• One 1 mg tablet taken once daily Recommended Dose The dose of anastrozole tablet is one 1 mg tablet taken once a day
• For patients with advanced breast cancer, anastrozole tablets should be continued until tumor progression
• Anastrozole tablets can be taken with or without food
• For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown
• In the ATAC trial, anastrozole was administered for five years [see Clinical Studies ]
• No dosage adjustment is necessary for patients with renal impairment or for
• Elderly patients [see Use in Specific Populations ]
• Patients with Hepatic Impairment No changes in dose are recommended for patients with mild-to-moderate hepatic impairment
• Anastrozole has not been studied in patients with severe hepatic impairment [see Use in Specific Populations ]

The tablets are white to off-white, round biconvex, film coated tablets, with “AHI” debossing on one side and plain on other side. 1 mg tablets ( 3 )

• Clinical studies
• Pediatric patients included a placebo-controlled trial in pubertal boys of adolescent age with gynecomastia and a single-arm trial in girls with McCune-Albright Syndrome and progressive precocious puberty
• 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
• Gynecomastia Study A randomized, double-blind, placebo-controlled, multi-center study enrolled 80 boys with pubertal gynecomastia aged 11 to 18 years. …

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. In studies 0004 and 0005, 50% of patients were 65 or older. Response rates and time to progression were similar for the over 65 and younger patients. In the ATAC study, 45% of patients were 65 years of age or older. …

• ?See FDA approved patient labeling (Patient Information).” Hypersensitivity Reactions Inform patients of the possibility of serious allergic reactions with swelling of the face, lips, tongue and/or throat (angioedema) which may cause difficulty in swallowing and/or breathing and to seek medical attention immediately [see Contraindications ]
• Ischemic Cardiovascular Events Patients with pre-existing ischemic heart disease should be informed that an increased incidence of cardiovascular events has been observed with anastrozole use compared to tamoxifen use. …

• Hypersensitivity 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 [see Adverse Reactions ]
• Patients with demonstrated hypersensitivity to anastrozole or any excipient

Tamoxifen: Do not use in combination with anastrozole. No additional benefit seen over tamoxifen monotherapy ( 7.1 , 14.1 ). Estrogen-containing products: Combination use may diminish activity of anastrozole ( 7.2 ). 7.1 Tamoxifen Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administration of anastrozole and tamoxifen did not affect the pharmacokinetics of tamoxifen or N-desmethyltamoxifen. …

In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with anastrozole use compared to tamoxifen use. Consider risks and benefits. ( 5.1 , 6.1 ) Decreases in bone mineral density may occur. Consider bone mineral density monitoring. ( 5.2 , 6.1 ) Increases in total cholesterol may occur. Consider cholesterol monitoring. ( 5.3 , 6.1 ) Embryo-Fetal Toxicity: Anastrozole may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. …

Serious adverse reactions with anastrozole occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling [see Adverse Reactions ( 6.2 )]. …

8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, anastrozole may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no studies of anastrozole use in pregnant women. Anastrozole caused embryo-fetal toxicities in rats at maternal exposure that were 9 times the human clinical exposure, based on area under the curve (AUC). …

Clinical trials have been conducted with anastrozole, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic. In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.