Abirtega 250 mg/1

Abiraterone acetate · TABLET · CivicaScript, LLC

No Recall History

Plain English

Abirtega is a tablet containing abiraterone acetate at 250 mg/1, taken oral. Manufactured by CivicaScript, LLC.

Key Facts

Brand Name: Abirtega
Generic Name: Abiraterone acetate
NDC Code (Product): 82249-011
Manufacturer: CivicaScript, LLC
Strength: 250 mg/1
Dosage Form: TABLET
Route: ORAL, ORAL
Marketing Status
Application #: ANDA208339
Marketing Start: 11/23/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death631 reports

fatigue451 reports

hot flush262 reports

asthenia256 reports

anaemia233 reports

hypokalaemia231 reports

diarrhoea209 reports

prostatic specific antigen increased207 reports

pneumonia201 reports

hypertension200 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ABIRTEGA is 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) ABIRTEGA 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: • ABIRTEGA 1,000 mg orally once daily with prednisone 5 mg orally twice daily. ( 2.1 ) Metastatic castration-sensitive prostate cancer: • ABIRTEGA 1,000 mg orally once daily with prednisone 5 mg orally once daily. ( 2.2 ) Patients receiving ABIRTEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ABIRTEGA 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 ABIRTEGA. 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 ABIRTEGA starting dose to 250 mg once daily. ( 2.4 ) • For patients who develop hepatotoxicity during treatment, hold ABIRTEGA until recovery. Retreatment may be initiated at a reduced dose. ABIRTEGA should be discontinued if patients develop severe hepatotoxicity. ( 2.4 ) 2.1 Recommended Dose for Metastatic CRPC The recommended dose of ABIRTEGA is 1,000 mg (four 250 mg tablets) orally once daily with predni…

Contraindications

4 CONTRAINDICATIONS None. • None ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during ABIRTEGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ABIRTEGA 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 ABIRTEGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ABIRTEGA 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 Pharmacology (12.3) ] . 7.2 Effects of Ab…

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 Hikma Pharmaceuticals USA Inc. at 1-877-233-2001 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 direc…

Frequently Asked Questions

What is Abirtega used for?

Abirtega contains Abiraterone acetate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Abirtega a controlled substance?

Abirtega is not classified as a controlled substance by the DEA.

What is the generic name for Abirtega?

The generic name for Abirtega is Abiraterone acetate. There are 12 other brand versions of Abiraterone acetate.

What is the NDC code for Abirtega 250 mg/1?

The NDC (National Drug Code) for Abirtega 250 mg/1 is 82249-011, listed by CivicaScript, LLC.

Product NDC

82249-011

Package NDC

82249-011-12

Other Abiraterone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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