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Apalutamide is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. non-metastatic castration-resistant prostate cancer.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Cerebrovascular and ischemic cardiovascular events occurred in patients receiving Apalutamide. Monitor for signs and symptoms of cerebrovascular disorders and ischemic heart disease. Optimize management of cardiovascular risk factors.. Fractures occurred in patients receiving Apalutamide. Evaluate patients for fracture risk and treat patients with bone-targeted agents according to established guidelines. Falls occurred in patients receiving Apalutamide with increased incidence in the elderly. Evaluate patients for fall risk. Seizure occurred in 0.4% of patients receiving Apalutamide. Permanently discontinue Apalutamide in patients who develop a seizure during treatment. Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients treated with Apalutamide. Interrupt Apalutamide if signs or symptoms of SCARs develop. Permanently discontinue if SCARs are confirmed. Interstitial Lung Disease (ILD)/pneumonitis occurred in patients treated with Apalutamide. Withhold Apalutamide for suspected ILD/pneumonitis. Permanently discontinue Apalutamide in patients with severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified. Embryo-Fetal Toxicity: Apalutamide can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. Interference with Immunoassay Measurement of Digoxin: Apalutamide can interfere with certain digoxin immunoassays, resulting in falsely elevated digoxin plasma concentration results. Cerebrovascular and Ischemic Cardiovascular Events Cerebrovascular and ischemic cardiovascular events, including events leading to death, occurred in patients receiving Apalutamide. Monitor for signs and symptoms of ischemic heart disease and cerebrovascular disorders. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of Apalutamide for Grade 3 and 4 events. In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with Apalutamide and 2% of patients treated with placebo. In a randomized study (TITAN) in patients with mCSPC, ischemic cardiovascular events occurred in 4.4% of patients treated with Apalutamide and 1.5% of patients treated with placebo. Across the SPARTAN and TITAN studies, 4 patients (0.3%) treated with Apalutamide, and 2 patients (0.2%) treated with placebo died from an ischemic cardiovascular event. In the SPARTAN study, cerebrovascular events occurred in 2.5% of patients treated with Apalutamide and 1% of patients treated with placebo. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following are discussed in more detail in other sections of the labeling: Cerebrovascular and Ischemic Cardiovascular Events. Fractures. Falls. Seizure. Severe Cutaneous Adverse Reactions (SCARs). Interstitial Lung Disease (ILD). The most common adverse reactions (≥10%) are fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 10%) that occurred more frequently in the Apalutamide-treated patients (≥ 2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture. Metastatic Castration-sensitive Prostate Cancer (mCSPC) TITAN, a randomized (1:1), double-blind, placebo-controlled, multi-center clinical study, enrolled patients who had mCSPC. In this study, patients received either Apalutamide at a dose of 240 mg daily or placebo. All patients in the TITAN study received a concomitant gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. The median duration of exposure was 20 months (range: 0 to 34 months) in patients who received Apalutamide and 18 months (range: 0.1 to 34 months) in patients who received placebo. Ten patients (1.9%) who were treated with Apalutamide died from adverse reactions. The reasons for death were ischemic cardiovascular events (n=3), acute kidney injury (n=2), cardio-respiratory arrest (n=1), sudden cardiac death (n=1), respiratory failure (n=1), cerebrovascular accident (n=1), and large intestinal ulcer perforation (n=1). Apalutamide was discontinued due to adverse reactions in 8% of patients, most commonly from rash (2.3%). Adverse reactions leading to dose interruption or reduction of Apalutamide occurred in 23% of patients; the most frequent (>1%) were rash, fatigue, and hypertension. Serious adverse reactions occurred in 20% of Apalutamide-treated patients and 20% in patients receiving placebo. Table 1 shows adverse reactions occurring in ≥10% on the Apalutamide arm in TITAN that occurred with a ≥2% absolute increase in frequency compared to placebo. Table 2 shows laboratory abnormalities that occurred in ≥15% of patients, and more frequently (>5%) in the Apalutamide arm compared to placebo. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.