Anastrozole

This label does not establish anastrozole-alone efficacy in premenopausal breast cancer, pediatric gynecomastia/precocious puberty, infertility, male hormonal use or primary prevention. Do not infer those doses or confuse absence from labeling with a complete review of every specialist off-label guideline.

Follow the oncology plan and reassess progression or intolerance before changing treatment. No weight-based pediatric algorithm, ovarian-suppression combination regimen or automatic switch schedule with other endocrine drugs is supplied.

Hypersensitivity to anastrozole or excipients; reported reactions include anaphylaxis, angioedema and urticaria. Current selected formal section 4 is hypersensitivity only; fetal toxicity is a warning and pregnancy use is inappropriate for this postmenopausal indication, rather than an invented additional formal contraindication.

The selected Arimidex label has no boxed warning. Bone, ischemic and fetal-risk warnings remain clinically significant.

Common reports include hot flashes, weakness, arthralgia/arthritis, pain, nausea/vomiting, rash, depression, headache, insomnia, osteoporosis/fractures and edema. Postmarketing reports include hepatitis, severe mucocutaneous reactions, anaphylaxis/angioedema, hypercalcemia and tendon disorders; frequencies/causality may be uncertain. Overdose requires Poison Help/medical assessment, supportive treatment and observation; no specific antidote. Label high-dose studies do not establish a safe overdose or self-escalation regimen; do not induce vomiting at home.

Do not coadminister tamoxifen: combination reduced anastrozole concentrations and did not provide benefit in ATAC. Estrogen-containing therapies should not be used because they may diminish its pharmacologic action. Do not infer that all sequential endocrine therapy is prohibited or self-stop a prescribed transition plan.

Selected volunteer study did not show a warfarin exposure/anticoagulation change. At 1 mg/day, clinically important CYP inhibition affecting other drugs is unlikely based on label data. These findings do not guarantee safety of every oncology combination, supplement or anticoagulant; retain normal indicated monitoring and medication review.

No renal dose adjustment is required; renal impairment reduces unchanged-drug clearance but has small total-clearance effect. No age-only adjustment. Stable hepatic cirrhosis/mild-to-moderate impairment requires no change; severe hepatic impairment has not been studied and needs oncology/pharmacy review.

Can cause fetal harm based on animal findings/mechanism; no pregnancy trials. Verify pregnancy status before therapy in females of reproductive potential, and use effective contraception during and for at least 3 weeks after last dose. Do not breastfeed during treatment and for 2 weeks afterward. Animal data suggest impaired female fertility; no human fertility guarantee is supplied.

Pediatric efficacy was not demonstrated in adolescent gynecomastia or girls with McCune-Albright syndrome/precocious puberty. Selected label does not establish anastrozole alone for premenopausal breast cancer; specialist ovarian-suppression regimens are not reviewed here. Do not transplant adult 1 mg dosing into a pediatric/off-label algorithm.

Anastrozole selectively inhibits aromatase, which converts adrenal androgens to estrone/estradiol in peripheral and breast-cancer tissue. It lowers estrogen without detectable adrenal corticosteroid/aldosterone suppression at studied doses; routine steroid replacement is not required by the label.

Fasted peak typically about 2 hours; food slows absorption but not overall extent, permitting dosing with/without meals. Protein binding about 40%, steady state about 7 days, mean elimination half-life about 50 hours. Hepatic metabolism via N-dealkylation, hydroxylation and glucuronidation predominates; about 10% total clearance is renal unchanged drug. No automatic dose reduction is justified solely by the long half-life.

Oncology follows disease response/progression and treatment adherence. Consider BMD monitoring, fracture risk and cholesterol, and assess ischemic history, liver/skin/tendon symptoms and troublesome joint pain. Pregnancy testing when relevant precedes treatment. No universal laboratory/scan interval, vitamin D/calcium dose or antiresorptive regimen is asserted.

Take 1 mg once daily and follow missed-dose rules. Discuss joint pain/hot flashes rather than independently stop. Seek immediate help for severe swelling, rash or chest pain/dyspnea. Report numbness/tingling suggesting carpal tunnel and tendon pain. Avoid unreviewed estrogen/tamoxifen combinations; follow contraception≥3 weeks and breastfeeding avoidance 2 weeks after stopping.

Tablet

White biconvex film-coated 1 mg; stylized A/arrow logo on one side, Adx 1 on reverse.

Package

ANI Pharmaceuticals · NDC 62559-670-30, bottle 30.

Status

Prescription oral endocrine therapy; selected postmenopausal breast-cancer indications.

Selected product

1 mg oral tablet.

Formulation limits

No labeled injectable, liquid or pediatric preparation reviewed. Generic appearances/excipients differ; no identification from brand color alone.

Ingredient distinction

Anastrozole is distinct from letrozole/exemestane; no mg-for-mg aromatase-inhibitor conversion inferred.

Store at controlled room temperature 20–25°C. Keep out of children’s reach and retain exact-package instructions; no unsupported after-opening discard interval, refrigeration or tablet-splitting regimen is supplied.