ixazomib

FDA Drug Profile — NINLARO

ixazomib is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including NINLARO. Available dosage form: capsule.

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) ] .