Erleada Special Precautions

Falls and fractures: Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.
In SPARTAN, a randomized study of patients with nmCRPC, fracture was reported for 11.7% of subjects treated with Apalutamide (Erleada) and 6.5% of subjects treated with placebo. Half of the subjects experienced a fall within 7 days before the fracture event in both treatment groups. Falls were reported for 15.6% of subjects treated with Apalutamide (Erleada) versus 9.0% of subjects treated with placebo. Evaluate patients for fracture and fall risk. In TITAN, a randomized study of patients with mCSPC, nonpathological fractures occurred in 6% of patients treated with Apalutamide (Erleada) and in 5% of patients treated with placebo.
Ischemic heart disease and ischemic cerebrovascular disorders: Ischemic heart disease and ischemic cerebrovascular disorders, including events leading to death, occurred in patients treated with Apalutamide (Erleada). Monitor for signs and symptoms of ischemic heart disease and ischemic cerebrovascular disorders. Optimize management of risk factors, such as hypertension, diabetes, or dyslipidemia.
In a randomized study SPARTAN, ischemic heart disease occurred in 4% of patients treated with Apalutamide (Erleada) and 3% of patients treated with placebo. In a randomized study TITAN, ischemic heart disease occurred in 4% of patients treated with Apalutamide (Erleada) and 2% of patients treated with placebo. Across the SPARTAN and TITAN studies, 6 patients (0.5%) treated with Apalutamide (Erleada) and 2 patients (0.2%) treated with placebo died from ischemic heart disease.
In the SPARTAN study, with a median exposure of 32.9 months for Apalutamide (Erleada) and 11.5 months for placebo, ischemic cerebrovascular disorders occurred in 4% of patients treated with Apalutamide (Erleada) and 1% of patients treated with placebo (see Adverse Reactions). In the TITAN study, ischemic cerebrovascular disorders occurred in a similar proportion of patients in the Apalutamide (Erleada) (1.5%) and placebo (1.5%) groups. Across the SPARTAN and TITAN studies, 2 patients (0.2%) treated with Apalutamide (Erleada) and no patients treated with placebo died from an ischemic cerebrovascular disorder.
Patients with history of unstable angina, myocardial infarction, congestive heart failure, stroke, or transient ischemic attack within six months of randomization were excluded from the SPARTAN and TITAN studies.
Seizure: Permanently discontinue Apalutamide (Erleada) in patients who develop a seizure during treatment.
In two randomized studies, SPARTAN and TITAN, five subjects (0.4%) treated with Apalutamide (Erleada) and two subjects (0.2%) treated with placebo experienced a seizure. In these studies, subjects with a history of seizure or predisposing factors for seizure were excluded. No seizures occurred in two other studies that enrolled 145 subjects. There is no clinical experience in re-administering Apalutamide (Erleada) to patients who experienced a seizure.
Severe Cutaneous Adverse Reactions (SCAR): Rare postmarketing cases of SCAR (including drug reaction with eosinophilia and systemic symptoms [DRESS] and Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], which can be life-threatening or may lead to death, have been reported with androgen receptor inhibitors including Apalutamide (Erleada). SCAR was not reported in clinical trials TITAN and SPARTAN. Discontinue Apalutamide (Erleada) immediately if signs or symptoms of SCAR develop (see Postmarketing data under Adverse Reactions).
Effects on Ability to Drive and Use Machines: No studies on the effects of Apalutamide (Erleada) on the ability to drive or use machines have been performed. It is not anticipated that Apalutamide (Erleada) will affect the ability to drive and use machines.