Voclosporin

FDA Drug Profile — LUPKYNIS

Voclosporin is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand name including LUPKYNIS. Available dosage forms: capsule, powder.

Drug Details

Generic Name
Voclosporin
Brand Names
LUPKYNIS
Application Number
NDA213716
Sponsor
Aurinia Pharma U.S., Inc.
NDC Codes
10
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.