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Enzalutamide

    DEA Class; Rx

    Common Brand Names; Xtandi

    • Antineoplastics, Antiandrogen

    Androgen receptor inhibitor
    Used for the treatment of castration-resistant prostate cancer
    Seizures have been reported

    Indicated for treatment of castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC)

    For the treatment of prostate cancer.
    • Asthenic conditions (47-51%)
    • Back pain (26-29%)
    • Constipation (23%)
    • Diarrhea (22%)
    • Arthralgia (21%)
    • Hot flush (18-20%)
    • Decreased appetite (19%)
    • Upper respiratory tract infection (16%)
    • Peripheral edema (12-15%)
    • Musculoskeletal pain (15%)
    • Hypertension (6.4-14%)
    • Falls (4.6-13%)
    • Headache (11-12%)
    • Decreased weight (12%)
    • Dyspnea (11%)
    • Dizziness (9.5-11%)
    • Muscular weakness (9.8%)
    • Insomnia (8.2-8.8%)
    • Hematuria (6.9-8.8%)
    • Nonpathologic fractures (4-8.8%)
    • Lower respiratory tract and lung infection (7.9-8.5%)
    • Dysgeusia (7.6%)
    • Spinal cord compression and cauda equina syndrome (7.4%)
    • Anxiety (6.5%)
    • Pollakiuria (4.8%)
    • Pruritus (3.8%)
    • Dry skin (3.5%)
    • Epistaxis (3.3%)

    Seizure occurred in patients receiving enzalutamide in randomized clinical trials; advise patients of risk of engaging in activities where sudden loss of consciousness could cause serious harm to themselves or others; permanently discontinue therapy in patients who develop seizure during treatment

    Posterior reversible encephalopathy syndrome (PRES) reported with use; discontinue therapy in patients who develop PRES

    Hypersensitivity reactions, including edema of the face, tongue, or lip have been observed; pharyngeal edema reported in postmarketing cases; advise patients who experience any symptoms of hypersensitivity to temporarily discontinue treatment and promptly seek medical care; permanently discontinue drug for serious hypersensitivity reactions

    In clinical studies, ischemic heart disease occurred; monitor for signs and symptoms of ischemic heart disease; optimize management of cardiovascular risk factors (eg, hypertension, diabetes, or dyslipidemia); discontinue treatment for Grade 3-4 ischemic heart disease

    Falls and fractures occurred; evaluate patients for fracture and fall risk; monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents; routine bone density assessment and treatment of osteoporosis with bone-targeted agents were not performed in the studies

    Safety and efficacy not established in females (see Pregnancy)

    Safety and efficacy not established in females

    Drug should not be handled by females who are or may become pregnant

    Not indicated for use in females; unknown whether distributed in breast milk

    Adults

    160 mg/day PO.

    Geriatric

    160 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Enzalutamide

    capsule

    • 40mg

    tablet

    • 40mg
    • 80mg