Abiret

Abiraterone Acetate USP

COMPOSITION

Each tablet contains Abiraterone Acetate USP 250mg Tablet.

INDICATIONS

Abiraterone Acetate is 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)

DOSAGE AND ADMINISTRATION

Recommended Dose For Metastatic CRPC: The recommended dose of Abiraterone Acetate 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 Abiraterone Acetate 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 Abiraterone Acetate should also receive a

gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone Acetate must be taken on an empty stomach, at least one hour before or at least two hours after a meal. The tablets should be swallowed whole with water. Do not crush or chew tablets.

Or, as directed by the registered physician.

Use in Pregnancy:

The safety and efficacy of Abiraterone Acetate have not been established in females. The drug can cause fetal harm and potential loss of pregnancy.

Use in Lactation:

There is no information available on the presence of Abiraterone Acetate in human milk, or on the effects on the breastfed child or milk production.

Packing: Abiret: Each box contains 7 tablets in Alu-Alu blister pack.

Prescribing Description

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