All Names: Abiraterone,Zytiga
Indications:1. Metastatic castration-resistant prostate cancer (CRPC); 2. Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Manufacturer:Glenmark,India
Customs Clearance Procedure:If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
INDICATIONS AND USAGE(适应症)
Abiraterone acetate tablets are 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(服用剂量)
Recommended Dose for Metastatic CRPC
The recommended dose of abiraterone acetate tablets 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 tablets 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 tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Abiraterone acetate tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. The tablets must be swallowed whole with water. Do not crush or chew tablets.
ADVERSE REACTIONS(不良反应)
Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess
Adrenocortical Insufficiency
Hepatotoxicity
Increased Fractures and Mortality in Combination with Radium Ra 223 Dichloride
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/c9eb9b46-f847-40a8-802c-a51b40406d5a/spl-doc?hl=abiraterone
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