Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Yonsa
  2. Zytiga

Descriptions


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) and metastatic high-risk castration-sensitive prostate cancer.

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

This product is available in the following dosage forms:

  • Tablet

Before Using

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abiraterone in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

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.

Drug Interactions

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Dasabuvir
  • Eliglustat
  • Selexipag

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.

  • Abametapir
  • Amiodarone
  • Amphetamine
  • Apalutamide
  • Benzphetamine
  • Carbamazepine
  • Cilostazol
  • Clozapine
  • Dabrafenib
  • Dextroamphetamine
  • Dihydrocodeine
  • Domperidone
  • Donepezil
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Enzalutamide
  • Fluoxetine
  • Fosphenytoin
  • Ifosfamide
  • Lisdexamfetamine
  • Lumacaftor
  • Lurasidone
  • Methamphetamine
  • Mitotane
  • Naloxegol
  • Olaparib
  • Ospemifene
  • Oxycodone
  • Ozanimod
  • Paclitaxel
  • Phenytoin
  • Piperaquine
  • Pixantrone
  • Radium Ra 223 Dichloride
  • Rifampin
  • Rosiglitazone
  • Simeprevir
  • St John's Wort
  • Tamoxifen
  • Thioridazine
  • Tucatinib
  • Vortioxetine

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.

  • Dextromethorphan
  • 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
  • Diabetes 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, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease, severe—Should not be used in patients with this condition.

Proper Use

Take this medicine only as directed by your doctor. 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 and follow the instructions carefully. Ask your doctor if you have questions.

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

It is best to take this medicine on an empty stomach, 1 hour before or 2 hours after a meal.

Your doctor may also give you other medicines (eg, gonadotropin-releasing hormone medicine) during treatment with abiraterone or you should have had surgical removal of the testes before using this medicine.

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 2 times a day.
      • Children—Use is not recommended.
    • For high-risk castration-sensitive 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 once 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 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

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine 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 treatment with this medicine and for 3 weeks after the last dose. 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 changes 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 first 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.

Abiraterone and prednisone/prednisolone may increase your risk for bone fractures and death when used together with radium 223 dichloride (radiation treatment). Tell your doctor if you are having any other treatment for your prostate cancer.

This medicine may cause hypoglycemia (low blood sugar), especially if you have diabetes and take certain medicines for diabetes. Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.

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

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

  1. Bladder pain
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. bloody or cloudy urine
  4. blurred vision
  5. bone fracture
  6. bone pain
  7. chest pain or discomfort
  8. decreased urine
  9. difficult, burning, or painful urination
  10. dry mouth
  11. fainting
  12. fast, pounding, or irregular heartbeat or pulse
  13. feeling of warmth
  14. frequent urge to urinate
  15. headache
  16. increased thirst
  17. increased urge to urinate during the night
  18. lightheadedness, dizziness, or fainting
  19. loss of appetite
  20. lower back or side pain
  21. mood changes
  22. muscle pain or cramps
  23. nausea
  24. nervousness
  25. numbness or tingling in the hands, feet, or lips
  26. pain or swelling in the arms or legs without any injury
  27. passing urine more often
  28. pounding in the ears
  29. rapid weight gain
  30. redness of the face, neck, arms, and occasionally, upper chest
  31. seizures
  32. slow heartbeat
  33. sudden sweating
  34. swelling
  35. swelling with pits or depressions on the skin
  36. trouble breathing
  37. unusual tiredness or weakness
  38. unusual weight gain or loss
  39. vomiting
  40. waking to urinate at night

Less common

  1. Arm, back, or jaw pain
  2. chest tightness or heaviness
  3. clay-colored stools
  4. cool, sweaty skin
  5. dark urine
  6. decreased urine output
  7. difficulty with breathing
  8. dilated neck veins
  9. extreme tiredness or weakness
  10. fever
  11. irregular breathing
  12. itching skin or rash
  13. light-colored stools
  14. stomach pain or tenderness
  15. sweating
  16. weakness
  17. weight gain
  18. yellow eyes or skin

Rare

  1. Darkening of the skin
  2. diarrhea
  3. mental depression

Incidence not known

  1. Anxiety
  2. chills
  3. cold sweats
  4. coma
  5. confusion
  6. cool, pale skin
  7. cough
  8. difficulty swallowing
  9. general feeling of discomfort or illness
  10. hives
  11. increased hunger
  12. irregular heartbeat, recurrent
  13. muscle pain, spasms, stiffness, tenderness, wasting, or weakness
  14. nightmares
  15. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  16. shakiness
  17. slurred speech
  18. stomach pain, continuing
  19. thickening of bronchial secretions
  20. unpleasant breath odor
  21. unusual tiredness or weakness
  22. vomiting of blood

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

  1. Belching
  2. body aches or pain
  3. difficulty with moving
  4. ear congestion
  5. heartburn
  6. indigestion
  7. joint pain
  8. loss of voice
  9. runny or stuffy nose
  10. sneezing
  11. sore throat
  12. stomach discomfort or upset
  13. 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.