Frequently Asked Questions

Abiraterone Acetate

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Zytiga

Miscellaneous antineoplastics


Pronunciation

Abiraterone acetate 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.

Abiraterone acetate 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 abiraterone acetate if:

  • you are allergic to any ingredient in abiraterone acetate
  • 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.

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Before using abiraterone acetate:

Some medical conditions may interact with abiraterone acetate. 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 abiraterone acetate. 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 abiraterone acetate's side effects
  • Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or rifapentine because they may decrease abiraterone acetate'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 abiraterone acetate

This may not be a complete list of all interactions that may occur. Ask your health care provider if abiraterone acetate 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 abiraterone acetate:

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

  • An extra patient leaflet is available with abiraterone acetate. Talk to your pharmacist if you have questions about this information.
  • Take abiraterone acetate 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 abiraterone acetate in your body may be increased if you take it with food. This may increase the risk of side effects.
  • Swallow abiraterone acetate whole with water. Do not break, crush, or chew before swallowing.
  • If you miss a dose of abiraterone acetate, 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 abiraterone acetate.

Important safety information:

  • Do not change your dose or stop taking abiraterone acetate or prednisone without checking with your doctor.
  • Abiraterone acetate 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 abiraterone acetate. Contact your doctor right away if you experience bone pain. Discuss any questions or concerns with your doctor.
  • Abiraterone acetate may cause harm to a developing fetus. Women who are pregnant or may become pregnant should not handle abiraterone acetate without protection (eg, gloves). If contact occurs, tell your doctor at once.
  • Men who take abiraterone acetate 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 abiraterone acetate and for 1 week after you stop taking it.
  • Tell your doctor or dentist that you take abiraterone acetate 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 abiraterone acetate. 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: Abiraterone acetate 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 abiraterone acetate is found in breast milk. Do not breast-feed while taking abiraterone acetate.

Possible side effects of abiraterone acetate:

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 abiraterone acetate:

Store abiraterone acetate 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 abiraterone acetate out of the reach of children and away from pets.

General information:

  • If you have any questions about abiraterone acetate, please talk with your doctor, pharmacist, or other health care provider.
  • Abiraterone acetate 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 abiraterone acetate 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 abiraterone acetate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abiraterone acetate. 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 abiraterone acetate.

Issue Date: February 4, 2015
Database Edition 15.1.1.002
Copyright © 2015 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.

Not all side effects for abiraterone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abiraterone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by abiraterone. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking abiraterone:

More common
  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • bone fracture
  • chest pain or discomfort
  • convulsions
  • decreased urine
  • difficult, burning, or painful urination
  • dizziness
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • frequent urge to urinate
  • headache
  • increased need to urinate
  • increased thirst
  • increased urge to urinate during the night
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or swelling in the arms or legs without any injury
  • passing urine more often
  • pounding in the ears
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • shortness of breath
  • slow heartbeat
  • sudden sweating
  • swelling
  • swelling with pits or depressions on the skin
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • waking to urinate at night
Less common
  • Abdominal or stomach pain or tenderness
  • arm, back, or jaw pain
  • chest tightness or heaviness
  • clay colored stools
  • cool, sweaty skin
  • dark urine
  • decreased appetite
  • decreased urine output
  • difficulty with breathing
  • dilated neck veins
  • extreme fatigue
  • fever
  • headache
  • irregular breathing
  • itching skin
  • rash
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • weakness
  • weight gain
  • wheezing
  • yellow eyes or skin
Rare
  • Darkening of the skin
  • diarrhea
  • mental depression

Some of the side effects that can occur with abiraterone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • chills
  • cough
  • difficulty with moving
  • ear congestion
  • heartburn
  • indigestion
  • joint pain
  • loss of voice
  • muscle cramps or spasms
  • muscle or bone pain
  • muscle stiffness
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • stomach discomfort or upset
  • swelling or stiffness of the joints

For Healthcare Professionals

Applies to abiraterone: oral tablet

General

In general, the most commonly reported side effects have included joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flushes, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, and upper respiratory tract infection. The most common adverse effects which resulted in discontinuation of abiraterone have included increased transaminases (ALT, AST), urosepsis, and heart failure.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension, edema, hot flushes, arrhythmias, atrial and ventricular tachycardia, supraventricular tachycardia, atrial flutter, bradycardia, AV block, chest pain or discomfort, angina, left ventricular dysfunction, cardiogenic shock, cardiomegaly, cardiomyopathy, decreased ejection fraction, and heart failure.[Ref]

Endocrine

Endocrine side effects have included adrenocortical insufficiency.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea and dyspepsia.[Ref]

Genitourinary

Genitourinary side effects have included urinary tract infection, urinary frequency, nocturia, and urosepsis.[Ref]

Hepatic

Hepatic side effects have included hepatotoxicity, increased AST, increased ALT, and increased bilirubin[Ref]

Metabolic

Metabolic side effects have included hypokalemia, fluid retention, and low serum phosphate.[Ref]

Musculoskeletal

Musculoskeletal side effects have included joint swelling or discomfort, muscle discomfort, arthritis, arthralgia, muscle spasms, musculoskeletal pain or discomfort, myalgia and fractures.[Ref]

Respiratory

Respiratory side effects have included cough and upper respiratory tract infection.[Ref]

References

1. "Product Information. Zytiga (abiraterone)." Centocor Inc, Malvern, PA.

More about abiraterone

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Interactions
  • Support Group
  • En Espanol
  • 6 Reviews - Add your own review/rating

Consumer resources

  • Abiraterone acetate
  • Abiraterone
  • Abiraterone (Advanced Reading)
  • Other brands: Zytiga

Professional resources

  • Abiraterone Acetate (AHFS Monograph)
  • Abiraterone Acetate (Wolters Kluwer)

Related treatment guides

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