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Generic Name: abiraterone (A bir A te rone)
Brand Names: Zytiga

What is Zytiga?

Zytiga (abiraterone) works in the body by preventing the actions of androgens (male hormones).

Zytiga is used together with prednisone to treat prostate cancer that has spread to other parts of the body.

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

Important information

You should not use Zytiga if you are allergic to abiraterone, if you have severe liver disease or if you are pregnant.

Before you take Zytiga, tell your doctor if you have liver disease, low levels of potassium in your blood, any type of infection, high blood pressure, congestive heart failure, or a history of heart disease, fluid retention, recent heart attack, or problems with your adrenal gland or pituitary gland.

Slideshow: Flashback: FDA Drug Approvals 2013

Although Zytiga is not for use by women, this medicine can harm an unborn baby or cause birth defects. Abiraterone tablets should not be handled by a woman who is pregnant or who may become pregnant.

While you are taking Zytiga and for at least 1 week after your treatment ends: Use a condom to prevent transfer of this medication to your sexual partner if she is pregnant. Use a condom plus another form of effective birth control if your sexual partner could become pregnant.

Zytiga must be taken on an empty stomach.

Before taking this medicine

You should not use Zytiga if you are allergic to abiraterone, if you have severe liver disease, or if you are pregnant.

To make sure Zytiga is safe for you, tell your doctor if you have:

  • liver disease;

  • heart disease, high blood pressure;

  • low levels of potassium in your blood;

  • a history of heart disease, fluid retention, or recent heart attack; or

  • a history of problems with your adrenal gland or pituitary gland.

While you are taking Zytiga and for at least 1 week after your treatment ends:

  • If your sexual partner is pregnant--Use a condom to prevent transfer of this medication to her.

  • If your sexual partner could become pregnant--Use a condom plus another form of effective birth control to prevent pregnancy.

FDA pregnancy category X. Although Zytiga is not for use by women, this medication can harm an unborn baby or cause birth defects. The tablets should not be handled by a woman who is pregnant or who may become pregnant. If this cannot be avoided, the woman should wear latex gloves.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether abiraterone passes into breast milk or if it could harm a nursing baby. Zytiga should not be used by a woman who is breast-feeding a baby.

How should I take Zytiga?

Take Zytiga exactly as prescribed by your doctor, Follow all directions on your prescription label. Zytiga is usually taken once per day while also taking prednisone two times per day. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your prednisone dosage needs may change if you have surgery, are ill, or are under stress. Do not change your medication dose or schedule without your doctor's advice.

Take this medicine with a full glass of water. Swallow the tablet whole.

Take Zytiga on an empty stomach. Do not eat anything for at least 2 hours before you take Zytiga and for at least 1 hour after you have taken the medicine.

Your blood pressure will need to be checked often, and you may need frequent blood tests at your doctor's office.

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

Store Zytiga at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose and take the medicine the following day on an empty stomach (no food for at least 2 hours before or 1 hour after you take Zytiga). Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss more than one dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Avoid eating 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.

Zytiga side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Zytiga: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Zytiga and call your doctor at once if you have:

  • swelling in your ankles or feet, pain in your legs;

  • rapid heartbeats, feeling short of breath (even with mild exertion);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  • pale skin, easy bruising, feeling like you might pass out;

  • upper stomach pain, itching, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

  • pain or burning when you urinate;

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

  • worsening dizziness, weakness, or tired feeling;

  • nausea, vomiting, ongoing diarrhea; or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Other common Zytiga side effects may include:

  • swelling or discomfort in your joints;

  • mild diarrhea;

  • cough; or

  • sweating, feeling very hot.

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.

See also: Side effects (in more detail)

What other drugs will affect Zytiga?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zytiga, especially:

  • cough or cold medicine that contains dextromethorphan;

  • the heart rhythm medicines flecainide or propafenone;

  • prostate or breast cancer medications such as leuprolide, buserelin, histrelin, or goserelin;

  • thioridazine;

  • an antidepressant - amitriptyline, doxepin, clomipramine, desipramine, imipramine, nortriptyline.

This list is not complete. Other drugs may interact with Zytiga, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Zytiga.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zytiga only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 3.01. Revision Date: 2013-02-04, 8:44:02 AM.

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