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Abiraterone (Oral route)

Pronunciation:

a-bir-A-ter-one AS-e-tate

Brand Names:

  • Zytiga

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Antiandrogen

Uses of This Medicine:

Note: Women of childbearing potential should not use or handle abiraterone tablets without protection (eg, gloves).

Abiraterone is used in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has already spread to other parts of the body). This medicine is used in patients who have received cancer treatments, such as docetaxel.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Abiraterone is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abiraterone in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Dabrafenib
  • Selexipag

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Repaglinide

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Adrenal or pituitary problems, history of or
  • Heart attack, recent or
  • Heart failure or
  • Heart or blood vessel disease, history of or
  • Heart rhythm problems (eg, ventricular arrhythmia) or
  • Hypertension (high blood pressure) or
  • Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.

Swallow the tablets whole with water. Do not break, crush, or chew it.

It is best to take this medicine on an empty stomach. Do not eat 2 hours before or 1 hour after taking abiraterone.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For castration-resistant prostate cancer:
      • Adults—1000 milligrams (mg) (two 500-mg tablets or four 250-mg tablets) once a day, taken together with 5 mg oral prednisone two times a day.
      • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed a dose of this medicine, take your normal dose on the following day. If more than one daily dose is missed, call your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for any unwanted effects that may be caused by this medicine.

Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the tablets without protection (eg, gloves). This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use a condom and another effective method of birth control during and for 1 week after the last dose of abiraterone. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Do not interrupt or stop using this medicine together with prednisone without asking your doctor. This may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

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
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 or rash
sweating
swelling of the face, fingers, feet, or lower legs
weakness
weight gain
yellow eyes or skin
Rare
Darkening of the skin
diarrhea
mental depression

Some side effects 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:

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 8/4/2017
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