Dosage And Administration

Recommended Dose For Metastatic CRPC

The recommended dose of Abirataj is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily.

Recommended Dose For Metastatic High-Risk CSPC

The recommended dose of Abirataj is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily.

Important Administration Instructions

Patients receiving ABIRATAJ should also receive a gonadotropin-releasing hormone (GnRH) analogconcurrently or should have had bilateral orchiectomy. ABIRATAJ must be taken on an empty stomach, either one hour before or two hours after a meal [see CLINICAL PHARMACOLOGY]. The tablets should be swallowed whole with water. Do not crush or chew tablets.

Dose Modification Guidelines In Hepatic Impairment And Hepatotoxicity

Hepatic Impairment

In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of ABIRATAJ to 250 mg once daily. In patients with moderate hepatic impairment monitor ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. If elevations in ALT and/or AST greater than 5X upper limit of normal (ULN) or total bilirubin greater than 3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ABIRATAJ and do not re-treat patients with ABIRATAJ [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Do not use ABIRATAJ in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Hepatotoxicity

For patients who develop hepatotoxicity during treatment with ABIRATAJ (ALT and/or AST greater than 5X ULN or total bilirubin greater than 3X ULN), interrupt treatment with ABIRATAJ [see WARNINGS AND PRECAUTIONS]. Treatment may be restarted at a reduced dose of 750 mg once daily following return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN. For patients who resume treatment, monitor serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter.

If hepatotoxicity recurs at the dose of 750 mg once daily, re-treatment may be restarted at a reduced dose of 500 mg once daily following return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.

If hepatotoxicity recurs at the reduced dose of 500 mg once daily, discontinue treatment with ABIRATAJ.

Permanently discontinue ABIRATAJ for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation [see WARNINGS AND PRECAUTIONS].

Dose Modification Guidelines For Strong CYP3A4 Inducers

Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during ABIRATAJ treatment.

If a strong CYP3A4 inducer must be co-administered, increase the ABIRATAJ dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Tablets (500 mg): purple, oval-shaped, film-coated tablets debossed with “AA” one side and “500” on the other side.

Tablets (250 mg): pink, oval-shaped, film-coated tablets debossed with “AA250” on one side.

Tablets (250 mg): white to off-white, oval-shaped tablets debossed with “AA250” on one side.

ABIRATAJ® (abiraterone acetate) Tablets are available in the strengths and packages listed below:

• ABIRATAJ® 500 mg film-coated Tablets

Purple, oval-shaped tablets debossed with “AA” one side and “500” on the other side.

NDC 57894-195-06 60 tablets available in high-density polyethylene bottles

• ABIRATAJ® 250 mg film-coated Tablets

Pink, oval-shaped tablets debossed with “AA250” on one side.

NDC 57894-184-12 120 tablets available in high-density polyethylene bottles

• ABIRATAJ® 250 mg uncoated Tablets

White to off-white, oval-shaped tablets debossed with “AA250” on one side.

NDC 57894-150-12 120 tablets available in high-density polyethylene bottles

Storage And Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted in the range from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Based on its mechanism of action, ABIRATAJ may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle ABIRATAJ 250 mg uncoated tablets or other ABIRATAJ tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use In Specific Populations].