ZYTIGA  500 MG ( ABIRATERONE ACETATE ) 60 FILM-COATED TABLETS

WHAT IS ABIRATERONE (YONSA, ZYTIGA)?
Abiraterone works by reducing androgen production in the body. Androgens are male hormones that can promote tumor growth in the prostate gland.

Abiraterone is used together with steroid medication (prednisone or methylprednisolone) to treat prostate cancer that has spread to other parts of the body. This medicine is used in men whose prostate cancer cannot be treated with surgery or other medicines.

Abiraterone may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ABIRATERONE (YONSA, ZYTIGA)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

swelling in your ankles or feet, pain in your legs;
shortness of breath;
pain or burning when you urinate, blood in your urine;
fast heartbeats;
headache, confusion;
a light-headed feeling, like you might pass out;
muscle weakness; or
liver problems--stomach pain (upper right side), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes).
Common side effects may include:

indigestion, vomiting, diarrhea, constipation;
painful or difficult urination;
swelling in your legs or feet;
feeling weak, feeling very hot;
muscle pain;
abnormal blood tests;
joint pain or swelling;
bruising; or
cold symptoms such as stuffy nose, sneezing, cough, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ABIRATERONE (YONSA, ZYTIGA)?
Abiraterone tablets should not be handled by a woman who is pregnant or who may become pregnant. This medicine can harm an unborn baby or cause miscarriage.

Zytiga Patient Information including How Should I Take

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING ABIRATERONE (YONSA, ZYTIGA)?
You should not use abiraterone if you are allergic to it.

Tell your doctor if you have ever had:

liver disease;
heart problems, high blood pressure;
a heart attack;
low levels of potassium in your blood; or
problems with your adrenal gland or pituitary gland.
Abiraterone is not for use by women or children.

This medicine can harm an unborn baby or cause miscarriage. Abiraterone tablets should not be handled by a woman who is pregnant or who may become pregnant. If this cannot be avoided, the woman should wear latex gloves.

Abiraterone can also harm an unborn baby if the father is taking this medicine at the time of conception or during pregnancy.

Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 weeks after your last dose.

Use a condom if your sex partner is pregnant.

Abiraterone should also not be used by a woman who is breast-feeding a baby.

Abiraterone is not approved for use by anyone younger than 18 years old.

HOW SHOULD I TAKE ABIRATERONE (YONSA, ZYTIGA)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Abiraterone is usually taken once per day while also taking a steroid 1 or 2 times per day. Follow your doctor's dosing instructions very carefully.

Your prednisone or methylprednisolone dosage needs may change if you have surgery, are ill, or are under stress. Do not change your medication dose or schedule without your doctor's advice.

Take this medicine with a full glass of water.

You may take Yonsa with or without food.

Take Zytiga on an empty stomach, at least 1 hour before or 2 hours after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood pressure will need to be checked often, and you may need frequent blood tests.

You should not stop using abiraterone or your steroid medicine suddenly. Follow your doctor's instructions about tapering your prednisone dose.

Store at room temperature away from moisture and heat.

Zytiga Patient Information including If I Miss a Dose

WHAT HAPPENS IF I MISS A DOSE (YONSA, ZYTIGA)?
Skip the missed dose and take the medicine the following day. Do not take two doses at one time.

Call your doctor for instructions if you miss more than one dose of abiraterone.

WHAT HAPPENS IF I OVERDOSE (YONSA, ZYTIGA)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

WHAT SHOULD I AVOID WHILE TAKING ABIRATERONE (YONSA, ZYTIGA)?
Avoid eating for at least 2 hours before you take Zytiga and for at least 1 hour after your dose. Food can increase the amount of Zytiga your body absorbs.

Avoid taking an herbal supplement containing St. John's wort.

WHAT OTHER DRUGS WILL AFFECT ABIRATERONE (YONSA, ZYTIGA)?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other prostate cancer medicines, especially radium Ra 223 (Xofigo).

Other drugs may affect abiraterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

WHERE CAN I GET MORE INFORMATION (YONSA, ZYTIGA)?
Your pharmacist can provide more information about abiraterone.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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