ixazomib
Drug Details
- Generic Name
- ixazomib
- Brand Names
- NINLARO
- Application Number
- NDA208462
- Sponsor
- Takeda Pharmaceuticals America, Inc.
- NDC Codes
- 3
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- IXAZOMIB CITRATE
Indications and Usage
1 INDICATIONS AND USAGE NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials [see Warnings and Precautions (5.9) and Clinical Studies (14.2 , 14.3) ] .