ABIRATERONE ACETATE tablet, film coated ABIRATERONE ACETATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ABIRATERONE ACETATE (UNII: EM5OCB9YJ6) (ABIRATERONE - UNII:G819A456D0)

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with None. The safety and efficacy of abiraterone acetate tablets have not been established in females. Based on findings from animal studies and the mechanism of action, abiraterone acetate tablets can cause fetal harm and potential loss of pregnancy. There are no human data on the use of abiraterone acetate tablets in pregnant women. In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (AUC) at the recommended dose (see Data). In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions an

Product summary:

Abiraterone Acetate Tablets, USP are available containing 250 mg or 500 mg of abiraterone acetate, USP. 500 mg film-coated tablets:  The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M  on one side of the tablet and AB500  on the other side. They are available as follows: NDC 0378-6921-91 bottles of 60 tablets 250 mg uncoated tablets:  The 250 mg tablets are white to off-white, oval, unscored tablets debossed with M on one side of the tablet and AB250  on the other side. They are available as follows: NDC 0378-6920-78 bottles of 120 tablets Storage and Handling:  Store at 20° to 25°C (68° to 77°F);  excursions permitted in the range from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep out of reach of children. Based on its mechanism of action, abiraterone acetate tablets may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle abiraterone acetate 250 mg uncoated tablets or other abiraterone acetate tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use in Specific Populations (8.1)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ABIRATERONE ACETATE- ABIRATERONE ACETATE TABLET, FILM COATED
ABIRATERONE ACETATE- ABIRATERONE ACETATE TABLET
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABIRATERONE ACETATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ABIRATERONE ACETATE
TABLETS.
ABIRATERONE ACETATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Dosage and Administration, Important Administration Instructions (2.3)
8/2021
Warnings and Precautions, Hypoglycemia (5.6) 10/2020
INDICATIONS AND USAGE
Abiraterone acetate tablets are a CYP17 inhibitor indicated in
combination with prednisone for the
treatment of patients with
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DOSAGE AND ADMINISTRATION
Metastatic castration-resistant prostate cancer:
•
Metastatic castration-sensitive prostate cancer:
•
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:
•
•
DOSAGE FORMS AND STRENGTHS
•
•
•
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
Abiraterone acetate tablets 1,000 mg orally once daily with prednisone
5 mg orally TWICE daily. (2.1)
Abiraterone acetate tablets 1,000 mg orally once daily with prednisone
5 mg orally ONCE daily. (2.2)
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 m