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ABIRATERONE ACETATE (abiraterone acetate)
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
250 mg tablet
- 4 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
500 mg tablet
- 2 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
250 mg tablet
- 4 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
500 mg tablet
- 2 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
abiraterone 250 mg tablet
- 4 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
abiraterone 500 mg tablet
- 2 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
Metastatic castration-resistant prostate cancer
- 4 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
Metastatic castration-sensitive prostate cancer
- 4 tablets (1,000 mg) by oral route once daily with water on an empty stomach at least 1 hour before or 2 hours after food
- None
Contraindicated
- Soltamox
- tamoxifen
- thioridazine
Severe
Moderate
- Conzip
- Synapryn
- tramadol
- tramadol-acetaminophen
- tramadol-glucosamine
- Ultracet
- Ultram
- Ultram Er
- Lactating mother
- Severe hepatic disease
Contraindicated
- Abnormal hepatic function tests
- Chronic heart failure
- Hypertension
- Hypokalemia
- Pregnancy
Severe
Moderate
- 30 day risk period post-myocardial infarction
- Edema
ABIRATERONE ACETATE (abiraterone acetate)
- Metastatic castration-resistant prostate cancer
- Metastatic castration-sensitive prostate cancer
- Abnormal hepatic function tests
- Accidental fall
- Anemia
- Cardiac arrhythmia
- Fracture
- Hypertension
- Hypokalemia
- Lymphopenia
- Arthralgias
- Bruising
- Cough
- Diarrhea
- Dyspepsia
- Dyspnea
- Edema
- Fatigue
- Fever
- Flushing
- Headache disorder
- Hematuria
- Hypercholesterolemia
- Hyperglycemia
- Increased urinary frequency
- Insomnia
- Myalgias
- Nausea
- Nocturia
- Pharyngitis
- Skin rash
- Upper respiratory infection
- Urinary tract infection
- Vomiting
More Frequent
Severe
Less Severe
- Atrial fibrillation
- Hyperbilirubinemia
- Increased alanine transaminase
- Increased aspartate transaminase
- Chest pain
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute hepatic failure
- Acute myocardial infarction
- Adrenal cortical insufficiency
- Body fluid retention
- Cardiomegaly
- Cardiomyopathy
- Heart failure
- Hepatitis
- Interstitial pneumonitis
- Myocardial ischemia
- Rhabdomyolysis
Less Severe
- Myopathy
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Abiraterone
No safety and efficacy established.
- 1 Day – 18 Years
- No safety and efficacy established.
Abiraterone
- Severity Level:
D
- Additional Notes: Based on animal data, fetal harm may occur, not indicated in women
Contraindicated
Abiraterone
Not indicated for use in women
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Not indicated for use in women |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Metastatic castration-resistant prostate cancer | |
| C61 | Malignant neoplasm of prostate |
| Metastatic castration-sensitive prostate cancer | |
| C61 | Malignant neoplasm of prostate |
| Z19.1 | Hormone sensitive malignancy status |
| 0-9 | A-Z |
|---|---|
| C61 | Malignant neoplasm of prostate |
| C61 | Malignant neoplasm of prostate |
| Z19.1 | Hormone sensitive malignancy status |
Formulary Reference Tool