Apalutamide Disease Interactions

Ischemic cardiovascular events, including events leading to death, occurred in patients receiving apalutamide. It is recommended to monitor for signs and symptoms of ischemic heart disease and to consider discontinuation of treatment for Grade 3 and 4 events. Care should be exercised when prescribing this agent in patients at risk of an ischemic cardiovascular event, such as in those patients with hypertension, diabetes, or dyslipidemia.

No clinically significant differences in the pharmacokinetics of apalutamide or its major metabolite were observed in patients with mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment. The effect on patients with severe hepatic impairment (Child-Pugh C) on apalutamide pharmacokinetics is unknown. Close monitoring of liver function is recommended in these patients.

Falls and fractures have occurred in patients receiving apalutamide. Care should be exercised when apalutamide is used in patients at risk for fractures or falls and in those patients with osteoporosis. It is recommended to evaluate patients for fracture and fall risk and to consider the use of bone-targeted agents as medically necessary.

No clinically significant differences in the pharmacokinetics of apalutamide or its major metabolite were observed in patients with mild to moderate renal impairment. The effect on patients with severe renal impairment or end-stage renal disease on apalutamide pharmacokinetics is unknown. Close monitoring of renal function is recommended in these patients.

The use of apalutamide may cause seizures. It is recommended to discontinue this agent in patients who develop a seizure while on treatment. Care should be exercised when using apalutamide in patients at risk or with a history of seizure disorder.