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Abirtega (Abiraterone acetate): Uses, Side Effects and Dosage

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Prescription (Rx)
Strength:
250 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Abirtega

What is ABIRTEGA?

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

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

Before taking ABIRTEGA, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • have liver problems
  • have diabetes
  • 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. ABIRTEGA can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should not handle ABIRTEGA uncoated tablets or other ABIRTEGA 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 ABIRTEGA and for 3 weeks after the last dose of ABIRTEGA.
  • are breastfeeding or plan to breastfeed. It is not known if ABIRTEGA 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. ABIRTEGA can interact with many other medicines.

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

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 ABIRTEGA?

  • Take ABIRTEGA and prednisone exactly as your healthcare provider tells you.
  • Take your prescribed dose of ABIRTEGA 1 time a day.
  • Your healthcare provider may change your dose if needed.
  • Do not change or stop taking your prescribed dose of ABIRTEGA or prednisone without talking with your healthcare provider first.

  • Take ABIRTEGA tablets as a single dose one time a day on an empty stomach. Do not eat food 2 hours before and 1 hour after taking ABIRTEGA.

  • Do not take ABIRTEGA with food. Taking ABIRTEGA with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
  • Swallow ABIRTEGA tablets whole. Do not crush or chew tablets.
  • Take ABIRTEGA tablets with water.
  • If you miss a dose of ABIRTEGA tablets 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 ABIRTEGA?

ABIRTEGA 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 ABIRTEGA. This can be life threatening. To decrease the chance of this happening, you must take prednisone with ABIRTEGA 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 ABIRTEGA.

Tell your healthcare provider if you get any of the following symptoms:

  • dizziness
  • confusion
  • fast or irregular heartbeats
  • muscle weakness
  • feel faint or lightheaded
  • pain in your legs
  • headache
  • swelling in your legs or feet
  • Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress.

  • Severe 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 ABIRTEGA and during treatment with ABIRTEGA. Liver failure may occur, which can lead to death. Tell your healthcare provider right away 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 death when ABIRTEGA 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.
  • Severe low blood sugar (hypoglycemia). Severe low blood sugar with ABIRTEGA can happen in people who have diabetes and take certain antidiabetic medicines. You and your healthcare provider should check your blood sugar levels regularly during treatment with ABIRTEGA and after you stop treatment. Your healthcare provider may also need to change the dose of your antidiabetic medicines. Signs and symptoms of low blood sugar may include:
  • headache
  • irritability
  • drowsiness
  • hunger
  • weakness
  • fast heartbeat
  • dizziness
  • sweating
  • confusion
  • feeling jittery

The most common side effects of ABIRTEGA include:

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

ABIRTEGA 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 ABIRTEGA. 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 ABIRTEGA?

  • Store ABIRTEGA at room temperature between 68oF to 77oF (20oC to 25oC).

Keep ABIRTEGA and all medicines out of the reach of children.

General information about the safe and effective use of ABIRTEGA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ABIRTEGA for a condition for which it was not prescribed. Do not give ABIRTEGA 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 ABIRTEGA that is written for health professionals.

What are the ingredients of ABIRTEGA?

Active ingredient: abiraterone acetate

Inactive ingredients: 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato).

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:

CivicaScript, LLC

Lehi, Utah 84043

Manufactured for:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922 USA by

Arab Pharmaceuticals Manufacturing PSC

PO Box 41, Sahab - Jordan

2INABI250TMCA-E

Revised: February 2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 208339 · View the label on DailyMed

Revision date stated in the text: February 2025

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Abirtega

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Cytochrome P450 17A1 Inhibitor
Active ingredient Abiraterone acetate 250 mg
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) HIKMA
FDA approval ANDA 208339Abbreviated New Drug Application (ANDA) – generic drug Approved October 31, 2018
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Abiraterone, Zytiga with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Recalls
  • October 6, 2026: Class II recall: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Packages (NDC)
Package
250 mg – 120 in 1 bottle, plastic NDC 82249-011-12

Source: FDA drug labeling via NLM DailyMed, data as of November 3, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.