Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Erleada (Apalutamide).
Abnormal heart rhythm: Erleada (Apalutamide) can cause changes to the normal rhythm of the heart, called QT prolongation. QT prolongation is a serious life-threatening condition. If you are at risk for heart rhythm problems (e.g., have heart failure, Angina, low potassium or magnesium levels; have congenital long QT syndrome; or are taking medications that can prolong the QT interval, such as quinidine, procainamide, Amiodarone, Sotalol, Flecainide), discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.
Bone health and fractures: Long-term use of other anti-androgen medications similar to Erleada (Apalutamide) has been shown to cause reduced bone strength and may increase the risk of bone fractures. Erleada (Apalutamide) appears to increase the risk of bone fractures. If you have Osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.
Heart disease: The risk of heart attack or heart failure is increased for people taking Erleada (Apalutamide). If you have a history of heart disease or risk factors for heart disease (Obesity, high blood cholesterol, smoking), discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.
Seizures: There have been rare reports of seizures occurring with Erleada (Apalutamide) in studies. The safety of using Erleada (Apalutamide) if you have a seizure disorder has not been determined. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.
Thyroid disease: Erleada (Apalutamide) may cause decreased thyroid gland function. If you have problems with your thyroid gland, Erleada (Apalutamide) may make these problems worse. If you experience symptoms of underactive thyroid, such as unexpectedly feeling cold, depression, constipation, or fatigue, let your doctor know. If you have a history of thyroid disease, discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.
Pregnancy: Erleada (Apalutamide) is not intended to be used by women. Erleada (Apalutamide) may cause harm to the developing baby and cause loss of pregnancy if the fetus is exposed to the medication. If you have a female partner who is or may become pregnant, it is important to use a condom, as well as a second effective method of birth control while receiving treatment and for 3 months after the last dose of Erleada (Apalutamide).
Breast-feeding: Erleada (Apalutamide) is not intended to be used by women.
Children: The safety and effectiveness of using Erleada (Apalutamide) have not been established for children.
