FDA Approves Zytiga



The U.S. Food and Drug Administration has approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).




Zytiga Patient Information

Read this Patient information that comes with Zytiga before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Zytiga?

Zytiga is a prescription medicine that is used along with prednisone. Zytiga is used to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body and who have received treatment with docetaxel.
Zytiga is not for use in women or children.



Who should not take Zytiga?

Do not take Zytiga if you are pregnant or may become pregnant. Zytiga may harm your unborn baby.
Women who are pregnant or who may become pregnant should not touch Zytiga without protection, such as gloves.

Before taking Zytiga

Before you take Zytiga, tell your healthcare provider if you:
  • have heart problems
  • have liver problems
  • have a history of adrenal and or pituitary problems
  • have any other medical conditions
  • plan to become pregnant. See "Who should not take Zytiga?"
  • are breastfeeding or plan to breastfeed. It is not known if Zytiga passes into your breast milk. You and your healthcare provider should decide if you will take Zytiga or breastfeed. You should not do both. See "Who should not take Zytiga?"
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Zytiga can interact with many other medicines.
You should not start or stop any medicine before you talk with the healthcare provider that prescribed Zytiga.
Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Zytiga?

  • Take Zytiga 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 Zytiga or prednisone without talking with your healthcare provider first.
  • Take Zytiga on an empty stomach. Do not take Zytiga with food. Taking Zytiga 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 1 hour after taking Zytiga.
  • Swallow Zytiga tablets whole.
  • Take Zytiga tablets with water.
  • Men who are sexually active with a pregnant women must use a condom during and for one week after treatment with Zytiga. 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 Zytiga. Talk with your healthcare provider if you have questions about birth control.
  • If you miss a dose of Zytiga 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.

Zytiga side effects

Zytiga may cause serious side effects including:
  • High blood pressure (hypertension), low blood potassium levels (hypokalemia) and fluid retention (edema). 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 may happen if you stop taking prednisone, get an infection, or are under stress.
  • Liver problems. Your healthcare provider will do blood test to check your liver before treatment with Zytiga and during treatment with Zytiga.
The most common side effects of Zytiga include:
  • 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
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Zytiga. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Zytiga?

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

General information about Zytiga.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Zytiga for a condition for which it was not prescribed. Do not give your Zytiga to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about Zytiga. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Zytiga that is written for healthcare professionals.
For more information contact Centocor Ortho Biotech, Inc. at 1-800-457-6399 or www.Zytiga.com.

What are the ingredients of Zytiga?

Active ingredient: abiraterone acetate
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate and colloidal silicon dioxide.

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