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Exemestane

    Brands

    DEA Class; Rx

    Common Brand Names; Aromasin

    • Antineoplastics, Aromatase Inhibitor

    Oral, irreversible, steroidal aromatase inhibitor for early breast cancer (estrogen-receptor positive after 2 to 3 years of tamoxifen therapy) or advanced breast cancer
    Lacks cross-resistance with other aromatase inhibitors or tamoxifen; more complete estrogen blockade than anastrazole or letrozole
    Similar response rate to megestrol but causes less weight gain and prolongs survival

    Breast Cancer

    Advanced disease

    • Indicated for treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy

    Adjuvant treatment

    • Indicated for adjuvant treatment of postmenopausal women with ER+ early breast cancer who have received 2-3 years of tamoxifen treatment and are switched to exemestane
    For the treatment of breast cancer in postmenopausal women.

    Hypersensitivity

    • Fatigue (22%)
    • Nausea (18%)
    • Hot flashes (13%)
    • Depression (13%)
    • Pain (13%)
    • Insomnia (11%)
    • Anxiety (10%)
    • Dyspnea (10%)
    • Dizziness (8%)
    • Headache (8%)
    • Edema (7%)
    • Vomiting (7%)
    • Flu-like syndrome (6%)
    • Abdominal pain (6%)
    • Anorexia (6%)
    • Cough (6%)
    • Hypertension (5%)
    • Constipation (5%)
    • Diarrhea (4%)

    Therapy should not be coadministered with estrogen-containing agents as these could interfere with pharmacological action

    Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed, due to the high prevalence of vitamin D deficiency in women with early breast cancer; women with vitamin D deficiency should receive supplementation with vitamin D

    Reductions in bone mineral density (BMD) seen with therapy over time; during adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed by bone densitometry at the commencement of treatment; monitor patients for bone mineral density loss and treat as appropriate

    Not indicated for breast cancer in premenopausal women

    Advise females of reproductive potential to use effective contraception during treatment and for 1 month after final dose

    Based on findings in animals, male and female fertility may be impaired by treatment

    Pregnancy Category: X

    Lactation: Excretion in milk unknown; because of potential for serious adverse reactions in breast-fed infants, advise women not to breastfeed during treatment and for 1 month after final dose

    Adults

    25 mg/day PO; if a potent CYP3A4 inducer is co-prescribed the maximum is 50 mg/day PO. Higher doses are tolerated but do not result in clinically significant increases in estrogen suppression.

    Elderly

    25 mg/day PO; if a potent CYP3A4 inducer is co-prescribed the maximum is 50 mg/day PO. Higher doses are tolerated but do not result in clinically significant increases in estrogen suppression.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Exemestane

    tablet

    • 25mg