Prostaxen

Warnings & Precautions

Seizure Apalutamide is not recommended for patients with a history of seizures or other factors that make a seizure more likely. These include, but are not limited to, underlying brain injury, a recent stroke (within one year), primary brain tumours or brain metastases. If a seizure happens during treatment with Apalutamide, the treatment should be stopped permanently. In two randomised studies (SPARTAN and TITAN), seizure occurred in 0.4% of patients receiving Apalutamide and in 0.2% of patients given placebo. Both studies left out patients with a history of seizure or factors that predispose to seizure. Falls and fractures Falls and fractures occurred in patients receiving Apalutamide. Before starting Apalutamide, patients should be assessed for their risk of fracture and falls. They should then keep being monitored and managed according to established treatment guidelines, and the use of bone-targeted agents should be considered. Ischaemic heart disease Ischaemic heart disease, including events that led to death, occurred in patients treated with Apalutamide. Most of these patients had cardiac risk factors. Patients should be monitored for signs and symptoms of ischaemic heart disease, and risk factors such as hypertension, diabetes or dyslipidaemia should be managed as well as possible, as per standard of care. Concomitant use with other medicinal products Apalutamide is a potent enzyme inducer, so it may cause many commonly used medicinal products to lose their effect. Concomitant use of Apalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters should generally be avoided when their therapeutic effect matters a great deal to the patient, and when the dose cannot easily be adjusted by monitoring efficacy or plasma concentrations. Co-administration of Apalutamide with warfarin and coumarin-Iike anticoagulants should be avoided. If Apalutamide is given together with an anticoagulant metabolised by CYP2C9 (such as warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be done. Recent cardiovascular disease Patients who had clinically significant cardiovascular disease in the past 6 months were excluded from the clinical studies. This covers severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (for example pulmonary embolism, or cerebrovascular accident including transient ischaemic attacks), and clinically significant ventricular arrhythmias. So the safety of Apalutamide in these patients has not been established. If Apalutamide is prescribed, patients with clinically significant cardiovascular disease should be monitored for risk factors such as hypercholesterolaemia, hypertriglyceridaemia or other cardio-metabolic disorders. After Apalutamide is started, patients should be treated for these conditions according to established treatment guidelines. Androgen deprivation therapy may prolong the QT interval Some patients have a history of QT prolongation or risk factors for it, and some are receiving concomitant medicinal products that might prolong the QT interval. In these patients, physicians should assess the benefit-risk ratio, including the potential for Torsade de pointes, before starting Apalutamide.