ERLEADA® (apalutamide) 60 mg film-coated tablets are slightly yellowish to greyish green, oblong-shaped tablets debossed with “AR 60” on one side. ERLEADA 60 mg tablets are available in bottles of 120 tablets. Each bottle contains silica gel desiccant.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Store in the original package. Do not discard desiccant. Protect from light and moisture.
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 Warnings and Precautions (5.1)].
Falls and Fractures
- Inform patients that ERLEADA is associated with an increased incidence of falls and fractures [see Warnings and Precautions (5.2, 5.3)].
- 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 Warnings and Precautions (5.4)].
- Inform patients that ERLEADA is associated with rashes and to inform their healthcare provider if they develop a rash [see Adverse Reactions (6.1, 6.2)].
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 Dosage and Administration (2.1)].
- Instruct patients who have difficulty swallowing tablets whole to mix the recommended dose of ERLEADA tablets with applesauce. Do not crush tablets [see Dosage and Administration (2.3)].
- 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 Warnings and Precautions (5.5)].
- 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 Use in Specific Populations (8.3)].
Janssen Ortho LLC
Gurabo, PR 00778
Janssen Products, LPHorsham, PA 19044
© 2019 Janssen Pharmaceutical Companies
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Revised: 11/2020|
|PATIENT INFORMATIONERLEADA® (er lee’dah)(apalutamide)Tablets|
|What is ERLEADA? ERLEADA is a prescription medicine used for the treatment of prostate cancer: |
|Before taking ERLEADA, tell your healthcare provider about all your medical conditions, including if you: |
| How should I take ERLEADA? |
| What are the possible side effects of ERLEADA? ERLEADA may cause serious side effects including: |
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|ERLEADA may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. Do not donate sperm during treatment with ERLEADA and for 3 months after the last dose of ERLEADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ERLEADA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
| How should I store ERLEADA? |
|General information about the safe and effective use of ERLEADA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ERLEADA for a condition for which it was not prescribed. Do not give ERLEADA to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ERLEADA that is written for health professionals.|
|What are the ingredients in ERLEADA? Active ingredient: apalutamideInactive ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.Manufactured by: Janssen Ortho LLC, Gurabo, PR 00778Manufactured for: Janssen Products, LP, Horsham, PA 19044© 2019 Janssen Pharmaceutical CompaniesFor more information, call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.erleada.com.|
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