Generic Name: abiraterone acetate (A-bir-A-ter-one AS-e-tate)
Brand Name: Zytiga

Zytiga is used for:

Treating a certain type of prostate cancer that has spread to other parts of the body. It is used along with another medicine (prednisone). It may also be used for other conditions as determined by your doctor.

Zytiga is an androgen biosynthesis inhibitor. It works by decreasing levels of certain hormones produced by the testes. This helps to prevent the growth of certain tumors that need these hormones to grow.

Do NOT use Zytiga if:

  • you are allergic to any ingredient in Zytiga
  • you have severe liver problems
  • you are pregnant or may become pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Zytiga:

Some medical conditions may interact with Zytiga. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, heart problems (eg, heart failure, irregular heartbeat), a recent heart attack, or high blood pressure
  • if you have low blood potassium levels or a history of adrenal gland problems, pituitary gland problems, or fluid retention or swelling (edema)

Some MEDICINES MAY INTERACT with Zytiga. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole because they may increase the risk of Zytiga's side effects
  • Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or rifapentine because they may decrease Zytiga's effectiveness
  • Carvedilol, chlorpromazine, desipramine, dextromethorphan, encainide, flecainide, iloperidone, maprotiline, metoprolol, nortriptyline, paroxetine, pimozide, propafenone, propranolol, risperidone, tetrabenazine, or thioridazine because the risk of their side effects may be increased by Zytiga

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zytiga may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zytiga:

Use Zytiga as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Zytiga. Talk to your pharmacist if you have questions about this information.
  • Take Zytiga by mouth on an empty stomach at least 1 hour before or 2 hours after eating. Do NOT take it with food. The amount of Zytiga in your body may be increased if you take it with food. This may increase the risk of side effects.
  • Swallow Zytiga whole with water. Do not break, crush, or chew before swallowing.
  • If you miss a dose of Zytiga, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 1 dose, contact your doctor.

Ask your health care provider any questions you may have about how to use Zytiga.

Important safety information:

  • Do not change your dose or stop taking Zytiga or prednisone without checking with your doctor.
  • Zytiga is taken along with prednisone. Use caution if your doctor tells you to stop taking prednisone or to reduce the dose, or if you experience events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. Contact your doctor right away if any of these events occur. You may need to increase your dose of prednisone before, during, and after stressful situations as directed by your doctor. Discuss any questions or concerns with your doctor.
  • An increased occurrence of bone fractures has been reported in patients using Zytiga. Contact your doctor right away if you experience bone pain. Discuss any questions or concerns with your doctor.
  • Zytiga may cause harm to a developing fetus. Women who are pregnant or may become pregnant should not handle Zytiga without protection (eg, gloves). If contact occurs, tell your doctor at once.
  • Men who take Zytiga should always use a condom when having sex with a woman who is pregnant. A condom and another form of effective birth control should be used when having sex with a woman who may become pregnant. Use these methods for as long as you take Zytiga and for 1 week after you stop taking it.
  • Tell your doctor or dentist that you take Zytiga before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver function, blood pressure, and blood potassium levels, may be performed while you use Zytiga. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Zytiga is not approved for use in women. It may cause harm to the fetus. If you become pregnant, contact your doctor. It is not known if Zytiga is found in breast milk. Do not breast-feed while taking Zytiga.

Possible side effects of Zytiga:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; heartburn; hot flushes; joint swelling or pain; mild muscle discomfort; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain or discomfort; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; leg pain; muscle pain, weakness, or cramping; severe or persistent headache, dizziness, or light-headedness; shortness of breath; sudden or unexplained weight gain; swelling of the hands, ankles, legs, or feet; symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; unusual nausea, stomach pain, or tiredness; yellowing of the skin or eyes); unusual bruising; unusual tiredness or weakness; urination problems (eg, difficult, increased, or painful urination).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Zytiga:

Store Zytiga at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zytiga out of the reach of children and away from pets.

General information:

  • If you have any questions about Zytiga, please talk with your doctor, pharmacist, or other health care provider.
  • Zytiga is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Zytiga or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zytiga. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zytiga. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Zytiga.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web2)