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Anastrozole Off-Label Use

Meaning

Anastrozole off-label use refers to the prescription of this FDA-approved medication for conditions other than its primary indication, which is the treatment of hormone-receptor-positive breast cancer in postmenopausal women. Common off-label applications in the hormonal health space include its use in men with hypogonadism on testosterone replacement therapy to manage estrogen levels, or in women with certain fertility issues. While this practice is legal and often evidence-based, it is not supported by the initial regulatory approval, requiring heightened clinical scrutiny and patient consent.