Drug Information

Zytiga (abiraterone acetate)

What is Zytiga?

Zytiga (abiraterone) works by reducing androgen production in the body. Androgens are male hormones that can promote tumor growth in the prostate gland.

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

Zytiga is used in men whose prostate cancer cannot be treated with surgery or other medicines.

Important Information

You should not use Zytiga if you have severe liver disease.

Before you take this medicine, tell your doctor if you have 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.

Although Zytiga is not for use by women, this medicine 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.

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.

Before taking this medicine

You should not use Zytiga if you are allergic to abiraterone, or if you have ever had:

  • severe liver disease.

Tell your doctor if you have ever had:

  • liver disease;
  • heart problems;
  • low levels of potassium in your blood; or
  • problems with your adrenal gland or pituitary gland.

Zytiga is not for use by women or children.

Abiraterone can harm an unborn baby or cause miscarriage. 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.

Abiraterone can also harm an unborn baby if the father is taking this medicine at the time of conception or during pregnancy.

Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 weeks after your last dose. Use a condom plus another form of effective birth control to prevent pregnancy.

Abiraterone should also not be used by a woman who is breast-feeding a baby.

Zytiga is not approved for use by anyone younger than 18 years old.

How should I take Zytiga?

Zytiga is usually taken once per day while also taking prednisone 1 or 2 times per day. Follow your doctor's dosing instructions very carefully and read all medication guides or instruction sheets.

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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 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.

Do not crush, chew, or break a tablet. Swallow the tablet whole with a full glass of water.

Your blood pressure will need to be checked often, and you may need frequent blood tests.

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

Store at room temperature away from moisture and heat.

Zytiga dosing information

Usual Adult Dose for Prostate Cancer:

1,000 mg orally once a day on an empty stomach (in combination with prednisone 5 mg orally 2 times a day)

Comments: No food should be consumed for at least 2 hours before the dose and for at least 1 hour after the dose of this drug.

Use: Treatment of metastatic castration-resistant prostate cancer

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 two doses at one time.

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 while taking Zytiga?

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 abiraterone your body absorbs.

Avoid taking an herbal supplement containing St. John's wort.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Zytiga side effects

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

Call your doctor at once if you have:

  • swelling in your ankles or feet, pain in your legs;
  • pain or burning when you urinate;
  • fast heartbeats;
  • headache, confusion;
  • muscle weakness; or
  • a light-headed feeling, like you might pass out.

Common Zytiga side effects may include:

  • vomiting, diarrhea, painful or difficult urination;
  • swelling;
  • feeling weak, feeling very hot;
  • joint pain or swelling;
  • bruising; or
  • cough, feeling short of breath.
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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.

What other drugs will affect Zytiga?

Other drugs may interact with abiraterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

In Summary

Common side effects of Zytiga include: decreased serum potassium, increased serum aspartate aminotransferase, increased serum triglycerides, fluid retention, and hypokalemia. Other side effects include: hypertension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to abiraterone: oral tablet

Along with its needed effects, abiraterone (the active ingredient contained in Zytiga) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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
  • 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 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
  • 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
  • seizures
  • slow heartbeat
  • sudden sweating
  • swelling
  • swelling with pits or depressions on the skin
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • waking to urinate at night

Less Common

  • 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 tiredness or weakness
  • fever
  • headache
  • irregular breathing
  • itching skin or rash
  • stomach pain or tenderness
  • sweating
  • weakness
  • weight gain
  • yellow eyes or skin

Rare

  • Darkening of the skin
  • diarrhea
  • mental depression

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

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More Common

  • Belching
  • body aches or pain
  • chills
  • cough
  • difficulty with moving
  • ear congestion
  • heartburn
  • indigestion
  • joint pain
  • loss of voice
  • muscle cramps, spasms, or stiffness
  • muscle or bone pain
  • 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

Endocrine

Uncommon (0.1% to 1%): Adrenocortical insufficiency

Hepatic

Very common (10% or more): Elevated ALT (up to 41.9%), elevated AST (up to 37.3%)

Common (1% to 10%): Elevated total bilirubin

Postmarketing reports: Fulminant hepatitis, acute liver failure and death

Cardiovascular

Very common (10% or more): Hot flush (up to 22.3%), hypertension (up to 21.6%)

Common (1% to 10%): Arrhythmia, chest pain/chest discomfort, angina pectoris, atrial fibrillation, tachycardia, myocardial infarction/ischemia, cardiac failure (e.g., congestive heart failure, left ventricular dysfunction, decreased ejection fraction)

Frequency not reported: QT prolongation

Musculoskeletal

Very common (10% or more): Joint swelling/discomfort (up to 30.3%), muscle discomfort (up to 26.2%), contusion (up to 13.3%)

Common (1% to 10%): Groin pain, fractures, falls

Postmarketing reports: Rhabdomyolysis, myopathy

Hematologic

Very common (10% or more): Lymphopenia (up to 38.2%), anemia

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 62.5%), hyperglycemia (up to 56.6%), hypernatremia (up to 32.8%), hypokalemia (up to 28.3%), fluid retention/edema (up to 26.7%), hypophosphatemia (up to 23.8%), elevated alkaline phosphatase, hypercholesterolemia

Renal

Frequency not reported: Renal failure

Other

Very common (10% or more): Fatigue (up to 39.1%)

Common (1% to 10%): Sepsis, pyrexia

Respiratory

Very common (10% or more): Cough (up to 17.3%), upper respiratory tract infection (up to 12.7%), dyspnea (up to 11.8%), nasopharyngitis (up to 10.7%)

Postmarketing reports: Non-infectious pneumonitis, allergic alveolitis

Genitourinary

Very common (10% or more): Urinary tract infection (up to 12%), hematuria (up to 10.3%)

Common (1% to 10%): Urinary frequency, nocturia

Psychiatric

Very common (10% or more): Insomnia (up to 13.5%

Gastrointestinal

Very common (10% or more): Constipation (up to 23.1%), diarrhea (up to 21.6%), dyspepsia (up to 11.1%), vomiting

Dermatologic

Common (1% to 10%): Rash

 

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