e daily according to their physician's instructions.
Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician.
Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION.
Patients should be advised that their liver function will be monitored using blood tests.
Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.
Manufactured by:
Patheon Inc.
Mississauga, Canada
Manufactured for:
Janssen Biotech, Inc.
Horsham, PA 19044
Issued: December 2011
PATIENT INFORMATION
ZYTIGA® (Zye-tee-ga)
(abiraterone acetate)
Tablets
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.
What should I tell my healthcare provider 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.
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