Abiraterone 250 mg/1
Abiraterone acetate · TABLET · PD-Rx Pharmaceuticals, Inc.
Abiraterone acetate is an oral medication used to treat certain types of prostate cancer by reducing testosterone production in the body. It is taken as a 250 mg tablet and requires a prescription from your doctor.
Key Facts
- Brand Name
- Abiraterone
- Generic Name
- Abiraterone acetate
- NDC Code (Product)
72789-213- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Strength
- 250 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208339
- Marketing Start
- 11/23/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablet is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Metastatic castration-resistant prostate cancer: • Abiraterone acetate tablets 1,000 mg orally once daily with prednisone 5 mg orally twice daily. ( 2.1 ) Metastatic castration-sensitive prostate cancer: • Abiraterone acetate tablets 1,000 mg orally once daily with prednisone 5 mg orally once daily. ( 2.2 ) Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone acetate tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. The tablets must be swallowed whole with water. Do not crush or chew tablets.( 2.3) Dose Modification: • For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the abiraterone acetate tablets starting dose to 250 mg once daily. ( 2.4 ) • For patients who develop hepatotoxicity during treatment, hold abiraterone acetate tablets until recovery. Retreatment may be initiated at a reduced dose. Abiraterone acetate tablets should be discontinued if patients develop severe hepatotoxicity. (…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency. ( 2.5 , 7.1 ) CYP2D6 Substrates: Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate. ( 7.2 ) 7.1 Drugs that Inhibit or Induce CYP3A4 Enzymes Based on in vitro data, abiraterone acetate is a substrate of CYP3A4. In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone [see Clinical…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess [see Warnings and Precautions ( 5.1 )]. Adrenocortical Insufficiency [see Warnings and Precautions ( 5.2 )]. Hepatotoxicity [see Warnings and Precautions ( 5.3 )]. Increased Fractures and Mortality in Combination with Radium Ra 223 Dichloride [see Warnings and Precautions (5.4) ]. The most common adverse reactions (≥10%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. ( 6.1 ) The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly com…
Frequently Asked Questions
What is Abiraterone used for?
Abiraterone acetate is an oral medication used to treat certain types of prostate cancer by reducing testosterone production in the body. It is taken as a 250 mg tablet and requires a prescription from your doctor.
Is Abiraterone a controlled substance?
Abiraterone is not classified as a controlled substance by the DEA.
What is the generic name for Abiraterone?
The generic name for Abiraterone is Abiraterone acetate. There are 8 other brand versions of Abiraterone acetate.
What is the NDC code for Abiraterone 250 mg/1?
The NDC (National Drug Code) for Abiraterone 250 mg/1 is 72789-213, listed by PD-Rx Pharmaceuticals, Inc..