Estatiga Dosage & Drug Information

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Core Prescribing Info

Contents

Abiraterone acetate

Indications/Uses

In combination w/ prednisone or prednisolone for newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination w/ androgen deprivation therapy (ADT); metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated; mCRPC in adult men whose disease has progressed on or after a docetaxel- based chemotherapy regimen.

Dosage/Direction for Use

1,000 mg (two 500 mg tab) as a single daily dose. In combination w/ prednisone or prednisolone: mHSPC Prednisone or prednisolone 5 mg daily, mCRPC Prednisone or prednisolone 10 mg daily.

Administration

Should be taken on an empty stomach: Swallow whole w/ water. Take at least 1 hr before or 2 hr after eating.

Contraindications

Hypersensitivity. Severe hepatic impairment [Child-Pugh class C]. Women who are or may be potentially pregnant.

MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic prostate cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Estatiga FC tab 500 mg

Packing/Price

1's

Estatiga

abiraterone

Manufacturer:

Delpharm