Abiraterone Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Prostate Cancer

Initial dose: 1000 mg orally once daily.

Abiraterone should be administered in combination with prednisone 5 mg orally twice daily.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh Class A): No adjustment recommended

Moderate liver dysfunction (Child-Pugh Class B): 250 mg orally once daily. If these patients develop elevations in ALT or AST greater than 5 times the ULN or total bilirubin greater than 3 times the ULN, abiraterone should be discontinued and not restarted.

Severe liver dysfunction (Child-Pugh Class C): Not recommended

Dose Adjustments

Hepatotoxicity:
In patients who develop ALT and/or AST levels greater than 5 times the ULN or total bilirubin greater than 3 times the ULN during treatment with abiraterone, treatment should be interrupted. Abiraterone may be restarted at 750 mg orally once daily when liver function returns to the patient's baseline or to AST and ALT less than or equal to 2.5 times the ULN and total bilirubin less than or equal to 1.5 times the ULN. If treatment is resumed, serum transaminases and bilirubin should be monitored at a minimum of every 2 weeks for 3 months and monthly thereafter.

If hepatotoxicity recurs at the 750 mg once daily dosage level, treatment may be restarted at a reduced dose of 500 mg orally once daily after liver function tests return to the patient's baseline or to AST and ALT less than or equal to 2.5 times the ULN and total bilirubin less than or equal to 1.5 times the ULN.

If hepatotoxicity recurs at the 500 mg once daily dosage level, treatment with abiraterone should be discontinued.

If a strong CYP450 3A4 inducer must be coadministered, increase the dosing frequency of abiraterone to twice a day during the coadministration period. Reduce the dose back to the previous dosing frequency if the strong CYP450 3A4 is discontinued.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Abiraterone tablets should be swallowed whole with water. Abiraterone should be administered on an empty stomach; food should not be consumed for at least 2 hours before administration of abiraterone and for at least 1 hour after administration.

Women who are pregnant or may become pregnant should not handle abiraterone tablets without protection (e.g., gloves).

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