(a'' bir a' ter one)

Brand Name(s): Zytiga^®; also available generically

WHY is this medicine prescribed?

Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Abiraterone comes as a tablet to take by mouth on an empty stomach with water, 1 hour before or 2 hours after eating any food. It is usually taken once daily. Take abiraterone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take abiraterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with water; do not split, chew, or crush them.

Continue to take abiraterone even if you feel well. Do not stop taking abiraterone or prednisone without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking abiraterone,

• tell your doctor and pharmacist if you are allergic to abiraterone, any other medications, or any of the ingredients in abiraterone tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal product may interact with abiraterone: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking abiraterone. Do not start this medication while taking abiraterone without discussing it with your healthcare provider.

• tell your doctor if you have an infection, a low level of potassium in your blood, or are experiencing unusual stress, have had a recent heart attack, or if you have or have ever had adrenal or pituitary gland problems, heart failure, an irregular heartbeat, including QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), high blood pressure, diabetes, increased amounts of cholesterol (a fat-like substance) and other fatty substances in the blood, osteoporosis (condition in which the bones become weak and fragile and can break easily), or heart or liver disease.

• you should know that abiraterone is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breastfeeding. If taken by a pregnant woman, abiraterone may harm the fetus. Women who are, could become, or may be pregnant should not touch abiraterone tablets without protective gloves. If a pregnant woman takes or touches abiraterone tablets, she should call her doctor immediately.

• men with a female partner taking abiraterone must use effective contraception during treatment and for 3 weeks after the final dose. Talk to your doctor about the types of birth control that are right for you.

• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking abiraterone.

• you should know that abiraterone can cause hypoglycemia (low blood sugar). Your doctor may tell you to monitor your blood sugar. Call your doctor or get emergency medical treatment if you have symptoms of hypoglycemia, including headache, dizziness, weakness, tiredness, sweating, hunger, rapid or irregular heartbeat, confusion, irritability, or feeling jittery

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss one dose, take your regular dose the next day. If you miss more than one dose, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Abiraterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint swelling or pain
• groin pain
• hot flashes (a sudden wave of mild or intense body heat)
• diarrhea
• constipation
• heartburn
• cough
• sore throat
• stuffy or runny nose
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• dizziness
• feeling faint or lightheaded
• headache
• confusion
• fast or irregular heartbeats
• muscle weakness or aches
• leg pain
• swelling of the hands, feet, ankles, or lower legs
• shortness of breath
• rash; hives; itching; difficulty breathing or swallowing; or swelling of the face, lips, tongue or throat
• unusual bruising or bleeding
• ,
• yellowing of the skin or eyes, nausea, vomiting, loss of appetite, extreme tiredness, lack of energy, dark urine, or pain in the upper right part of the stomach
• flu-like symptoms such as fever
• blood in urine
• difficult, painful, or frequent urination
• falling
• bone fracture

Abiraterone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• fast or irregular heartbeat
• lightheadedness, dizziness, or fainting
• shortness of breath or difficulty breathing
• swelling of the feet, ankles, or lower legs
• unexplained weight gain

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly. Your doctor will order certain lab tests to check your body's response to abiraterone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2023.