Abiraterone Acetate  250 mg tablets

Therapeutically equivalent to Zytiga.®†

TERMS AND CONDITIONS

Product Information

Instructions for use, safety information, and warnings.

Patient Assistance

Find out if you qualify for the Abiraterone Instant Savings* Program.

Prescribing Information

Download PDF of prescribing information for Abiraterone Acetate.

Contact

Call us toll-free at (855) 820-3230 for information and assistance.

By participating in the ABIRATERONE ACETATE Instant Savings Program for ABIRATERONE ACETATE manufactured and labeled by Apotex, you acknowledge that you meet the eligibility criteria and will comply with the terms and conditions described below:
  • You may not use the ABIRATERONE ACETATE Instant Savings Program if you have prescription drug coverage under Medicaid, Medicare, TRICARE, the Federal Employee Health Benefit Program, or other federal or state healthcare programs including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico (formerly known as "La Reforma de Salud"). You may not use the ABIRATERONE ACETATE Instant Savings Program if you are uninsured or have no prescription drug coverage for ABIRATERONE ACETATE.
  • The ABIRATERONE ACETATE Instant Savings* Program is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs, which reimburse you for the entire cost of your prescription drugs (i.e you have no cost-sharing obligation).
  • Offer not available for residents of California or Massachusetts or where prohibited by law. Void if copied, transferred, purchased, altered or traded. This is not an insurance program. This offer is restricted to residents of the United States and Puerto Rico. You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • Eligible commercially insured patients may pay as little as $5 for a 30-day supply of ABIRATERONE ACETATE manufactured and labeled by Apotex with savings card. All eligible commercially insured patients are required to pay $5 of their applicable cost-sharing. Thereafter, Apotex will subsidize up to $500 in cost-sharing for a 30 day supply of ABIRATERONE ACETATE manufactured and labeled by Apotex with savings card. In the event your cost-sharing obligation for ABIRATERONE ACETATE under your commercial health insurance is more than $500 for a 30-day supply, you will be responsible for any cost-sharing beyond $500 for a 30-day supply, for a maximum benefit of $6,000 per year. The ABIRATERONE ACETATE Instant Savings Program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The ABIRATERONE ACETATE Instant Savings Program will be accepted only at participating pharmacies.
  • The ABIRATERONE ACETATE Instant Savings Program is not health insurance.
  • The offer is good only in the U.S. and Puerto Rico.
  • The ABIRATERONE ACETATE Instant Savings Program is limited to one patient during the offer period ending October 31, 2020 and is not transferable.
  • Apotex reserves the right, at its sole discretion, to amend, to rescind, revoke, or terminate the offer at any time.
  • There are no membership fees for this savings program.
  • If you receive co-payment assistance under the ABIRATERONE ACETATE Instant Savings Program, your personal information will be used to process payment for your prescription under such program through an Apotex vendor.

For questions about enrolling in the program or using the card, please call toll free at (855)-820-3230. Pharmacists, please call 855-825-1678 for questions about processing the card.

IMPORTANT SAFETY INFORMATION

Who should not take ABIRATERONE ACETATE?

ABIRATERONE ACETATE is not for use in women.

Do not take ABIRATERONE ACETATE if you are pregnant or may become pregnant. ABIRATERONE ACETATE may harm your unborn baby. Women who are pregnant or may become pregnant should not touch ABIRATERONE ACETATE 250-mg uncoated tablets or other ABIRATERONE ACETATE tablets if broken, crushed, or damaged without protection, such as gloves.

ABIRATERONE ACETATE is not for use in women or children. Keep ABIRATERONE ACETATE and all medicines out of the reach of children.

Before you take ABIRATERONE ACETATE, tell your healthcare provider if you:

  • Have heart problems
  • Have liver problems
  • Have a history of adrenal problems
  • Have a history of pituitary problems
  • Have any other medical conditions
  • Plan to become pregnant (See "Who should not take ABIRATERONE ACETATE?")
  • Are breastfeeding or plan to breastfeed. It is not known if ABIRATERONE ACETATE passes into your breast milk. ABIRATERONE ACETATE is not for use in women.
  • Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ABIRATERONE ACETATE can interact with many other medicines.

How should I take ABIRATERONE ACETATE TABLETS?

  • Take ABIRATERONE ACETATE and prednisone exactly as your healthcare provider tells you.
  • Take your prescribed dose of ABIRATERONE ACETATE one time a day. Your healthcare provider may change your dose if needed.
  • Do not stop taking your prescribed dose of ABIRATERONE ACETATE or prednisone without talking to your healthcare provider first.
  • You should not start or stop taking any medicine before you talk with the healthcare provider who prescribed ABIRATERONE ACETATE.
  • Take ABIRATERONE ACETATE on an empty stomach, either 1 hour before or 2 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.
  • Men who are sexually active with a pregnant woman must use a condom during and for 3 weeks after treatment with ABIRATERONE ACETATE. If their female partner may become pregnant, a condom and another form of birth control must be used during and for 3 weeks after treatment with ABIRATERONE ACETATE. Talk with your healthcare provider if you have any questions about birth control.
  • 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.

What are the possible side effects of ABIRATERONE ACETATE TABLETS?

ABIRATERONE ACETATE may cause serious side effects including:

  • High blood pressure (hypertension), low blood potassium levels (hypokalemia), and fluid retention (edema).
    Tell your healthcare provider if you get any of the following symptoms:
    • Dizziness
    • Fast heartbeats
    • Feel faint or lightheaded
    • Headache
    • Confusion
    • Muscle weakness
    • Pain in your legs
    • Swelling in your legs or feet
  • Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.
  • Liver problems. You may develop changes in liver function blood tests. 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

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
  • Cough
  • Headache
  • Low red blood cells (anemia)
  • High blood cholesterol and triglycerides
  • High blood sugar levels
  • Certain other abnormal blood tests

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

The risk information here is not complete. Please read the full Prescribing Information and Patient Information for ABIRATERONE ACETATE. For more information, ask your healthcare provider or pharmacist.