duvelisib
Drug Details
- Generic Name
- duvelisib
- Brand Names
- COPIKTRA
- Application Number
- NDA211155
- Sponsor
- Catalent Pharma Solutions, LLC
- NDC Codes
- 4
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- DUVELISIB
Indications and Usage
1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines lines of systemic therapy. ( 1 ) Limitations of Use : COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. ( 1 )