A: No dosage adjustment is necessary for patients with renal impairment.

A: Human experience of overdose with ZYTIGA^® is limited. There is no specific antidote. In the event of an overdose, stop ZYTIGA^® and undertake general supportive measures, including monitoring for arrhythmias and cardiac failure, and assess liver function.

A: Patients receiving ZYTIGA^® should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

A: Based on in vitro data, ZYTIGA^® 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 ZYTIGA^® treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA^® dosing frequency. 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.

ZYTIGA^® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug. In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone, a CYP2C8 substrate, was increased by 46% when administered with a single dose of 1,000 mg ZYTIGA^®. Patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA^®.

See full Prescribing Information for additional information on Drug Interactions.

A:

• ZYTIGA^® is not indicated for use in females. ZYTIGA^® can cause fetal harm and potential loss of pregnancy.
• Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of ZYTIGA^®.
• Based on animal studies, ZYTIGA^® may impair reproductive function and fertility in males of reproductive potential
• Advise females who are pregnant or women who may be pregnant not to handle ZYTIGA^® 250 mg uncoated tablets or other ZYTIGA^® tablets if broken, crushed, or damaged without protection, eg, gloves
• Safety and efficacy of ZYTIGA^® in females and in pediatric patients have not been established.
• 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 ZYTIGA^® to 250 mg once daily. Do not use ZYTIGA^® 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 ZYTIGA^® treatment.
• For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required.

See full Prescribing Information for additional information in Specific Populations.

A: Store at 20ºC (68ºF to 77ºF); excursions permitted in the range from 15ºC to 30ºC (59ºF to 86ºF). Keep ZYTIGA^® out of reach of children. Based on its mechanism of action, ZYTIGA^® may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle ZYTIGA^® 250 mg uncoated tablets or other ZYTIGA^® tablets if broken, crushed, or damaged without protection, eg, gloves.