ERLEADA (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

NDC Number 59676-600-12

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.

17 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 Warnings and Precautions (5.1)].

Falls and Fractures

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 Warnings and Precautions (5.4)].

Rash

  • 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)].

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 Warnings and Precautions (5.5)].

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 Use in Specific Populations (8.3)].

Manufactured by:
Janssen Ortho LLC
Gurabo, PR 00778

Manufactured for:
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:
  • that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone, OR
  • that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone.
It is not known if ERLEADA is safe and effective in females. It is not known if ERLEADA is safe and effective in children.
Before taking ERLEADA, tell your healthcare provider about all your medical conditions, including if you:
  • have a history of heart disease
  • have high blood pressure
  • have diabetes
  • have abnormal amounts of fat or cholesterol in your blood (dyslipidemia)
  • have a history of seizures, brain injury, stroke, or brain tumors
  • are pregnant or plan to become pregnant. ERLEADA can cause harm to your unborn baby and loss of pregnancy (miscarriage).
  • have a partner who is pregnant or may become pregnant.
    • Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after the last dose of ERLEADA.
    • Males should use a condom during sex with a pregnant female.
    Talk with your healthcare provider if you have questions about birth control.
  • are breastfeeding or plan to breastfeed. It is not known if ERLEADA passes into breast milk.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA can interact with many other medicines. You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA. Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take ERLEADA?
  • Take ERLEADA exactly as your healthcare provider tells you.
  • Your healthcare provider may change your dose if needed.
  • Do not stop taking your prescribed dose of ERLEADA without talking with your healthcare provider first.
  • Take your prescribed dose of ERLEADA 1 time a day, at the same time each day.
  • Take ERLEADA with or without food.
  • Swallow ERLEADA tablets whole.
  • If you miss a dose of ERLEADA, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day. You should not take extra tablets to make up the missed dose.
  • You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with ERLEADA unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
  • If you take too much ERLEADA, call your healthcare provider or go to the nearest hospital emergency room.
  • If you are unable to swallow ERLEADA tablets whole, you may:
    • Place your dose of ERLEADA in a container that contains 4 ounces (120 mL) of applesauce and stir. Do not crush the tablets.
    • Wait 15 minutes and stir the mixture.
    • Wait another 15 minutes and stir the mixture until the tablets are well mixed with no chunks remaining.
    • Swallow the mixture right away using a spoon.
    • Rinse the container with 2 ounces (60 mL) of water and drink the water mixture right away.
    • Repeat the rinse with 2 ounces (60 mL) of water one more time to make sure that you take your full dose of ERLEADA.
    • Swallow all the applesauce and medicine mixture within 1 hour of preparation. Do not store ERLEADA that is mixed with applesauce.
What are the possible side effects of ERLEADA? ERLEADA may cause serious side effects including:
  • Heart disease, stroke, or mini-stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA. Call your healthcare provider or get medical help right away if you get:
  • chest pain or discomfort at rest or with activity
  • shortness of breath
  • numbness or weakness of the face, arm, or leg, especially on one side of the body
  • trouble talking or understanding
  • trouble seeing in one or both eyes
  • dizziness, loss of balance or coordination, or trouble walking
  • Fractures and falls. ERLEADA treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA.
  • Seizure. Treatment with ERLEADA may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA if you have a seizure during treatment.
The most common side effects of ERLEADA include:
  • feeling very tired
  • joint pain
  • rash. Tell your healthcare provider if you get a rash.
  • decreased appetite
  • fall
  • weight loss
  • hypertension
  • hot flash
  • diarrhea
  • fracture
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?
  • Store ERLEADA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store ERLEADA in the original package.
  • The bottle of ERLEADA contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away (discard) the desiccant.
  • Protect ERLEADA from light and moisture.
Keep ERLEADA and all medicines out of the reach of children.
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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