idelalisib
idelalisib is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Zydelig. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- idelalisib
- Brand Names
- Zydelig
- Application Number
- NDA205858
- Sponsor
- Gilead Sciences, Inc.
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- IDELALISIB
Indications and Usage
1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. ( 1 ) Limitations of use: Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. ( 1 , 6.1 ) Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas. ( 6.1 ) Limitations of Use Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.