NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
Drug Details
- Generic Name
- NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE
- Brand Names
- AKEEGA
- Application Number
- NDA216793
- Sponsor
- Janssen Biotech, Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ABIRATERONE ACETATE, NIRAPARIB TOSYLATE MONOHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. ( 1 , 2.1 )