1. Treatment of castration-resistant prostate cancer (且雄性素去除療法失敗後屬無症狀或輕症而不需使用化學治療者 OR 且已接受過Docetaxel治療者) <20201207>
2. Treatment of metastatic castration-sensitive prostate cancer (且與雄性素去除療法併用) <20201207>
#仿單變更2020

Antineoplastic Agent, Antiandrogen

Absorption: Rapid
Distribution: 110 L
Protein binding: Parent drug: 97% to 98% to primarily albumin; active metabolite: 95% to plasma proteins.
Metabolism: Primarily hepatic via CYP2C8 (responsible for formation of active metabolite N-desmethyl enzalutamide) and CYP3A4; carboxylesterase 1 metabolizes N-desmethyl enzalutamide and enzalutamide to the inactive carboxylic acid metabolite.
Half-life elimination: Parent drug: 5.8 days (range: 2.8 to 10.2 days); N-desmethyl enzalutamide: 7.8 to 8.6 days.
Excretion: Urine (71%); feces (14%); primarily as inactive metabolite.

Pregnancy

Enzalutamide is contraindicated in pregnant women and is not indicated for use in women.

Enzalutamide is not indicated for use in women.

Common
Cardiovascular: Hypertension (11% to 14.2% ), Peripheral edema (11.5% to 15.4%)
Dermatologic: Flushing (14.8% to 20.3%)
Endocrine metabolic: Weight decreased (10.9% to 12.4%)
Gastrointestinal: Constipation (12.6% to 23.2%), Diarrhea (11.5% to 21.8%), Loss of appetite (18.9%), Taste sense altered (7.6%)
Hematologic: Neutropenia, All Grades (15%)
Musculoskeletal: Arthralgia (20.5% to 21.4%), Backache (19.1% to 28.6%), Musculoskeletal pain (15% to 16.4%)
Neurologic: Asthenia, Dizziness, Headache (11% to 12.1%), Vertigo.
Respiratory: Dyspnea (11% ), Upper respiratory infection (10.9% to 16.4%)
Other: Fatigue
Serious
Hematologic: Neutropenia, Grades 3 and 4 (1%)
Neurologic: Cauda equina syndrome, Posterior reversible encephalopathy syndrome, Seizure (up to 0.9% ), Spinal cord compression.

160 mg orally once daily

Renal impairment, mild to moderate: No dosage adjustment required.

Hepatic impairment, mild, moderate, or severe: No dosage adjustment required.