obinutuzumab
Drug Details
- Generic Name
- obinutuzumab
- Brand Names
- Gazyva
- Application Number
- BLA125486
- Sponsor
- Genentech, Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION, SOLUTION, CONCENTRATE
- Routes
- INTRAVENOUS
- Active Ingredients
- OBINUTUZUMAB
Indications and Usage
1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. ( 1.2 , 14 ) in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. ( 1.2 , 14 ) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy ( 1.3 , 14 ) 1.1 Chronic Lymphocytic Leukemia (CLL) GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. 1.2 Follicular Lymphoma (FL) GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen . GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma . 1.3 Lupus Nephritis (LN) GAZYVA is indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.