Abiraterone

Abiraterone is a prescription medication used to treat prostate cancer that has spread to other parts of the body. Abiraterone belongs to a group of drugs called CYP17 inhibitors, which work by decreasing the amount of testosterone in the body. Testosterone stimulates prostate cancer cells to grow.

This medication comes in tablet form and is taken once a day without food, on an empty stomach. Do not take abiraterone with food as food may cause more of the medicine to be absorbed by the body than is needed. Do not eat 2 hours before taking abiraterone and do not eat for 1 hour after taking abiraterone. 

Take abiraterone with water. Swallow abiraterone tablets whole. Do not crush or chew abiraterone tablets.

Common side effects of abiraterone include joint swelling or pain, muscle aches, hot flushes, and diarrhea.

Abiraterone is a prescription medication approved to treat men with advanced prostate cancer that has spread to other areas of the body. It is often used when other medical or surgical treatments have not worked. Abiraterone is used in combination with prednisone.

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

Abiraterone may be found in some form under the following brand names:

• Yonsa

• Zytiga

Serious side effects have been reported with abiraterone. See "Precautions”.

Common side effects of abiraterone include the following:

• joint swelling or pain
• muscle aches
• hot flushes
• diarrhea
• urinary tract infection
• cough
• irregular heartbeats
• urinate more often than normal
• need to get up at night to urinate
• heartburn
• cold like symptoms
• bone fractures

This is not a complete list of abiraterone side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antifungal medicines 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)
• carbamazepine (Carbatrol, Epitol, Tegretol)
• phenobarbital (Luminal)
• phenytoin (Dilantin, Phenytek)
• nefazodone (Serzone)
• rifabutin (Mycobutin)
• rifampin (Rifadin, in Rifamate, in Rifater, Rimactane)
• rifapentine (Priftin)
• telithromycin (Ketek)
• thioridazine (Mellaril)
• nimodipine (Nimotop)
• St. John's wort

This is not a complete list of abiraterone drug interactions. Ask your doctor or pharmacist for more information.

Abiraterone may cause serious side effects including:

• high blood pressure, low blood potassium levels, and fluid retention. Tell your healthcare provider if you get any of the following symptoms:
  • dizziness
  • fast heartbeats
  • feel faint or lightheaded
  • headache
  • confusion
  • muscle weakness
  • pain in your legs
  • swelling in your legs or feet
• adrenal problems. This may occur if you stop taking prednisone, get an infection, or are under stress.
• liver problems or toxicity. Your healthcare provider will do blood tests to check your liver before treatment with Zytiga and during treatment with Zytiga.

Do not take abiraterone if you:

• are allergic to abiraterone or to any of its ingredients
• are pregnant or may become pregnant. Abiraterone may harm your unborn baby.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of abiraterone there are no specific foods that you must exclude from your diet when receiving abiraterone.

Before taking abiraterone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to abiraterone or to any of its ingredients
• have heart problems
• have liver problems
• have a history of adrenal and/or pituitary problems
• have any other medical conditions
• plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Abiraterone can interact with many other medicines.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Abiraterone falls into category X. Do not take abiraterone if you are pregnant or may become pregnant. Abiraterone may harm your unborn baby. Women who are pregnant or who may become pregnant should not touch abiraterone without protection, such as gloves.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if abiraterone passes into your breast milk. You and your healthcare provider should decide if you will take abiraterone or breastfeed. You should not do both. 

Take abiraterone and prednisone exactly as your healthcare provider tells you.

• Your healthcare provider may change your dose if needed.
• Do not stop taking your prescribed dose of abiraterone or prednisone without talking with your healthcare provider first.
• Take abiraterone on an empty stomach. Do not take abiraterone with food. Taking abiraterone with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
• No food should be eaten 2 hours before and for 1 hour after taking abiraterone.
• Swallow abiraterone tablets whole.
• Take abiraterone tablets with water.
• Men who are sexually active with a pregnant woman must use a condom during and for one week after treatment with abiraterone. If their sexual partner may become pregnant, a condom and another form of birth control must be used during and for one week after treatment with abiraterone. Talk with your healthcare provider if you have questions about birth control.
• If you miss a dose of abiraterone 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.

Take abiraterone exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of abiraterone is:

• Metastatic castration-resistant prostate cancer: 1,000 mg once daily in combination with prednisone 5 mg twice daily.
• Metastatic castration-sensitive prostate cancer: 1,000 mg once daily in combination with prednisone 5 mg once daily.

Abiraterone must be taken on an empty stomach. No food should be consumed for at least 2 hours before the dose of abiraterone is taken and for at least 1 hour after the dose of abiraterone is taken. The tablets should be swallowed whole with water.

If you take too much abiraterone, call your local Poison Control Center or seek emergency medical attention right away.

If abiraterone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store abiraterone at 59°F to 86°F (15°C to 30°C).
• Keep abiraterone and all medicines out of the reach of children.