Zytiga (Abiraterone Acetate)

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Abiraterone is used in combination with another medication (prednisone) to treat prostate cancer that has spread to other parts of the body in men who have not been helped by other treatments including docetaxel (Docefrez, Taxotere). Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.

Abiraterone comes as a tablet to take by mouth on an empty stomach, 1 hour before or 2 hours after eating any food. It is usually taken once a day. 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.

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. Be sure to mention any of the following: certain antifungals such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); clarithromycin (Biaxin, in Prevpac); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); nefazodone; rifabutin (Mycobutin); rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); rifapentine (Priftin); telithromycin (Ketek); and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with abiraterone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have an infection or are experiencing unusual stress, have had a recent heart attack, or if you have or have ever had adrenal or pituitary gland problems, an irregular heartbeat, high blood pressure, a low level of potassium in your blood, 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 breast-feeding. If taken by pregnant women, 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.you should know that men must use a condom if having sex with a pregnant woman during treatment and for 1 week after finishing treatment with abiraterone. If you are having sex with someone who may become pregnant, you must use a condom and another form of birth control during your treatment and for 1 week after finishing treatment. Talk to your doctor about the types of birth control that are right for you.

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

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

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

• joint swelling or pain
• hot flashes (a sudden wave of mild or intense body heat)
• diarrhea
• heartburn

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
• unusual bruising or bleeding
• extreme tiredness
• lack of energy
• nausea
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• difficult, painful or frequent urination

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

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.

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.