Voclosporin
Drug Details
- Generic Name
- Voclosporin
- Brand Names
- LUPKYNIS
- Application Number
- NDA213716
- Sponsor
- Catalent Pharma Solutions, LLC
- NDC Codes
- 9
- Dosage Forms
- CAPSULE, POWDER
- Routes
- ORAL
- Active Ingredients
- VOCLOSPORIN
Indications and Usage
1 INDICATIONS AND USAGE LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies ( 14 )] for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. LUPKYNIS is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). ( 1 , 14 ) Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.