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ABIRATERONE ACETATE tabletABIRATERONE ACETATE tablet, film coated


  1. Patient Information
  2. Before Taking Abiraterone Acetate, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  3. How Should I Take Abiraterone Acetate?
  4. Abiraterone Acetate May Cause Serious Side Effects Including:
  5. Tell Your Healthcare Provider If You Get Any Of The Following Symptoms:
  6. The Most Common Side Effects Of Abiraterone Acetate Include:
  7. How Should I Store Abiraterone Acetate?
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. 500 Mg Tabletsmanufactured By:
  11. 250 Mg Tabletsmanufactured By:
  12. Manufactured For:
  13. Distributed By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions

  • Inform patients that abiraterone acetate is associated with hypertension, hypokalemia, and peripheral edema that may lead to QT prolongation and Torsades de Pointes in patients who develop hypokalemia while taking abiraterone acetate. Advise patients that their blood pressure, serum potassium and signs and symptoms of fluid retention will be monitored clinically at least monthly. Advise patients to adhere to corticosteroids and to report symptoms of hypertension, hypokalemia, or edema to their healthcare provider[

    Abiraterone acetate is a prescription medicine that is used along with prednisone. Abiraterone acetate is used to treat men with prostate cancer that has spread to other parts of the body.

    It is not known if abiraterone acetate is safe and effective in females or children.

Before Taking Abiraterone Acetate, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have heart problems
  • have liver problems
  • have a history of adrenal problems
  • have a history of pituitary problems
  • are receiving any other treatment for prostate cancer
  • are pregnant or plan to become pregnant. Abiraterone acetate can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should not handle abiraterone acetate uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, such as gloves.
  • 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 with abiraterone acetate and for 3 weeks after the last dose of abiraterone acetate.
  • are breastfeeding or plan to breastfeed. It is not known if abiraterone acetate passes into your breastmilk.

Tell your healthcare provider about all the medicines you take or treatments you receive, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Abiraterone acetate can interact with many other medicines.

You should not start or stop any medicine before you talk with the healthcare provider that prescribed abiraterone acetate.

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 Abiraterone Acetate? 

  • Take abiraterone acetate and prednisone exactly as your healthcare provider tells you.
  • Take your prescribed dose of abiraterone acetate 1 time a day.
  • Your healthcare provider may change your dose if needed.
  • Do not change or stop taking your prescribed dose of abiraterone acetate or prednisone without talking with your healthcare provider first.
  • Take abiraterone acetate on an empty stomach, at least one hour before or at least two hours after a meal.Do not take abiraterone acetate with food.Taking abiraterone acetate with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
  • Swallow abiraterone acetate tablets whole. Do not crush or chew tablets.
  • Take abiraterone acetate tablets with water.
  • If you miss a dose of abiraterone acetate or prednisone, take your prescribed dose the following day. If you miss more than 1 dose, tell your healthcare provider right away.
  • Your healthcare provider will do blood tests to check for side effects.

Abiraterone Acetate May Cause Serious Side Effects Including: 

  • High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema), and irregular heartbeats can happen during treatment with abiraterone acetate. This can be life threatening. To decrease the chance of this happening, you must take prednisone with abiraterone acetate exactly as your healthcare provider tells you. Your healthcare provider will check your blood pressure, do blood tests to check your potassium levels, and check for any signs and symptoms of fluid retention every month during treatment with abiraterone acetate.

Tell Your Healthcare Provider If You Get Any Of The Following Symptoms: 

  • dizziness
  • fast or irregular heartbeats
  • feel faint or lightheaded
  • headache
  • confusion
  • muscle weakness
  • pain in your legs
  • swelling in your legs or feet
  • Adrenal problemsmay happen if you stop taking prednisone, get an infection, or are under stress.
  • Liver problems. You may develop changes in liver function blood test. Your healthcare provider will do blood tests to check your liver before treatment with abiraterone acetate and during treatment with abiraterone acetate. Liver failure may occur, which can lead to death. Tell your healthcare provider if you notice any of the following changes:
    • yellowing of the skin or eyes
    • darkening of the urine
    • severe nausea or vomiting
  • Increased risk of bone fracture and deathwhen abiraterone acetate and prednisone or prednisolone, is used in combination with a type of radiation called radium Ra 223 dichloride. Tell your healthcare provider about any other treatments you are taking for prostate cancer.

The Most Common Side Effects Of Abiraterone Acetate Include: 

  • feeling very tired
  • joint pain
  • high blood pressure
  • nausea
  • swelling in your legs or feet
  • low blood potassium levels
  • hot flushes
  • diarrhea
  • vomiting
  • infected nose, sinuses, or throat (cold)
  • cough
  • headache
  • low red blood cells (anemia)
  • high blood cholesterol and triglycerides
  • high blood sugar levels
  • certain other abnormal blood tests

Abiraterone acetate 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.

These are not all the possible side effects of abiraterone acetate. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Abiraterone Acetate? 

  • Store abiraterone acetate at room temperature between 68 F to 77 F (20 C to 25 C).

Keep abiraterone acetate and all medicines out of the reach of children.

General information about abiraterone acetate.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use abiraterone acetate for a condition for which it was not prescribed. Do not give abiraterone acetate to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about abiraterone acetate that is written for health professionals.

Active Ingredient: 

abiraterone acetate

Inactive Ingredients: 

500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

Product of Belgium

500 Mg Tabletsmanufactured By: 

Patheon France S.A.S., Bourgoin Jallieu, France

250 Mg Tabletsmanufactured By: 

Patheon Inc., Mississauga, Canada

Manufactured For: 

Janssen Biotech, Inc., Horsham, PA 19044

Distributed By: 

Patriot Pharmaceuticals, LLC, Horsham, PA 19044

For more information, call Janssen Biotech, Inc. at 1-800-526-7736 (1-800-JANSSEN).

2018 Patriot Pharmaceuticals, LLC



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