ABIRATERONE ACETATE- abiraterone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) None. Risk Summary The safety and efficacy of abiraterone acetate have not been established in females. Based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. There are no human data on the use of abiraterone acetate 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). Data Animal 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 to 17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients. Risk Summary The safety and efficacy of abiraterone acetate have not been established in females. There is no information available on the presence of abiraterone in human milk, or on the effects on the breastfed child or milk production. Contraception Males Based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate [see Use in Specific Populations (8.1)]. Infertility Based on animal studies, abiraterone acetate may impair reproductive function and fertility in males of reproductive potential [see Nonclinical Toxicology (13.1)]. Safety and effectiveness of abiraterone acetate in pediatric patients have not been established. Of the total number of patients receiving abiraterone acetate in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The pharmacokinetics of abiraterone were examined in subjects with baseline mild (N=8) or moderate (N=8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of abiraterone acetate increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. In another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (N=8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function. No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of abiraterone acetate to 250 mg once daily. Do not use abiraterone acetate in patients with baseline severe hepatic impairment (Child-Pugh Class C). If elevations in ALT or AST >5 X ULN or total bilirubin >3 X ULN occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate treatment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.4), Warnings and Precautions (5.3), and Clinical Pharmacology (12.3)]. No dosage adjustment is necessary for patients with renal impairment [see Clinical Pharmacology (12.3)].

Product summary:

Abiraterone acetate tablets are available in the strengths and packages listed below: Abiraterone acetate tablets, USP, 250 mg , are available as white to off-white, oval-shaped, uncoated tablets debossed with “AN65” on one side and plain on the other side. They are supplied as follows: Unit dose packages of 30 (3 x 10) NDC 60687-455-21 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. 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 TABLET
AMERICAN HEALTH PACKAGING
----------
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
metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
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. (2.