Erleada Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Cerebrovascular and Ischemic Cardiovascular Events: Inform patients that ERLEADA has been associated with cerebrovascular and ischemic cardiovascular events. Advise patients to seek immediate medical attention if any symptoms suggestive of a cardiovascular or a cerebrovascular event occur [see Cerebrovascular and Ischemic Cardiovascular Events under Precautions].
Falls and Fractures: Inform patients that ERLEADA is associated with an increased incidence of falls and fractures [see Fractures and Falls under Precautions].
Seizures: Inform patients that ERLEADA has been associated with an increased risk of seizure. Discuss conditions that may predispose to seizures and medications that may lower the seizure threshold. Advise patients of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Inform patients to contact their healthcare provider right away if they experience a seizure [see Seizure under Precautions].
Rash: Inform patients that ERLEADA is associated with rashes and to inform their healthcare provider if they develop a rash [see Clinical Trial Experience and Post-Marketing Experience under Adverse Reactions].
Dosage and Administration: Inform patients receiving concomitant gonadotropin-releasing hormone (GnRH) analog therapy that they need to maintain this treatment during the course of treatment with ERLEADA.
Instruct patients to take their dose at the same time each day (once daily). ERLEADA can be taken with or without food. Each tablet should be swallowed whole.
Inform patients that in the event of a missed daily dose of ERLEADA, they should take their normal dose as soon as possible on the same day with a return to the normal schedule on the following day. The patient should not take extra tablets to make up the missed dose [see Recommended Dosage under Dosage & Administration].
Instruct patients who have difficulty swallowing tablets whole to mix there commended dose of ERLEADA tablets with applesauce. Do not crush tablets [see Alternate Method of Administration under Dosage & Administration].
Embryo-Fetal Toxicity: Inform patients that ERLEADA can be harmful to a developing fetus. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA. Advise male patients to use a condom if having sex with a pregnant woman [see Use in Pregnancy: Embryo-Fetal Toxicity under Precautions].
Infertility: Advise male patients that ERLEADA may impair fertility and not to donate sperm during therapy and for 3 months following the last dose of ERLEADA [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].