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Falls and fractures. XTANDI treatment may increase your risk for falls and fractures. Falls were not caused by loss of consciousness (fainting) or seizures. Your healthcare provider will monitor your risks for falls and fractures during treatment with XTANDI.
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XTANDI 160 mg (four 40 mg capsules) administered orally once daily. Swallow capsules whole. XTANDI can be taken with or without food.
Patients receiving XTANDI should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
WARNINGS AND PRECAUTIONS
1.Seizure occurred in 0.4% of patients receiving XTANDI. In patients with predisposing factors, seizures were reported in 2.2% of patients. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
2.Posterior reversible encephalopathy syndrome (PRES): Discontinue XTANDI.)
3.Hypersensitivity: Discontinue XTANDI.
4.Ischemic Heart Disease: Optimize management of cardiovascular risk factors. Discontinue XTANDI for Grade 3-4 events.
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For more Prescribing information，please check the → “FDA Prescribing Information”.
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