Enzalutamide

DEA Class; Rx

Common Brand Names; Xtandi

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

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• 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