abiraterone

What is the most important information I should know about abiraterone?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is abiraterone?

Abiraterone is used together with a steroid medicine (prednisone or methylprednisolone) to treat prostate cancer that has spread to other parts of the body (metastatic) and cannot be treated with surgery or other medicines.

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

What should I discuss with my healthcare provider before taking abiraterone?

Tell your doctor if you have ever had:

• liver disease;
• diabetes (especially if you use pioglitazone or repaglinide);
• 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 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 pregnant or able to get pregnant. Keep using birth control for at least 3 weeks after your last dose.

How should I take abiraterone?

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 abiraterone dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Your steroid dose needs may change if you have an infection or are under stress. Do not change your dose or stop using your steroid medicine without your doctor's advice.

You may take Yonsa with or without food.

Your blood pressure will need to be checked often, and you may need frequent blood tests. If you have diabetes, your blood sugar should be checked carefully, especially if you take pioglitazone or repaglinide.

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

What happens if I miss a dose?

Skip the missed dose and take the medicine the following day. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking abiraterone?

Do not eat food 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 and may cause side effects.

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

What are the possible side effects of abiraterone?

• swelling in your ankles or feet, pain in your legs;
• fast or irregular heartbeats;
• a light-headed feeling, like you might pass out;
• severe headache, blurred vision, pounding in your neck or ears;
• pain or burning when you urinate;
• low red blood cells (anemia) --pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
• low blood potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• liver problems --stomach pain (upper right side), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes); or
• severe low blood sugar --headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky.

Common side effects may include:

• feeling very weak or tired;
• feeling very hot;
• high blood sugar;
• increased blood pressure;
• swelling in your legs or feet;
• anemia, low blood potassium;
• painful urination;
• abnormal liver function tests or other blood tests;
• joint pain or swelling;
• headache;
• nausea, vomiting, diarrhea; 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 other drugs will affect abiraterone?

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 current medicines. Many drugs can affect abiraterone, especially:

• other prostate cancer medicines, especially radium Ra 223 (may increase your risk of fractures while you are taking abiraterone); or
• pioglitazone or repaglinide to treat diabetes (may cause severe low blood sugar hypoglycemia while you are taking abiraterone.

This list is not complete and many other drugs may affect abiraterone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about abiraterone.