daprodustat

FDA Drug Profile — Jesduvroq

Drug Details

Generic Name
daprodustat
Brand Names
Jesduvroq
Application Number
NDA216951
Sponsor
Catalent Pharma Solutions, LLC
NDC Codes
10
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DAPRODUSTAT

Indications and Usage

1 INDICATIONS AND USAGE JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ is not indicated for use: • As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. • For treatment of anemia of chronic kidney disease in patients who are not on dialysis. JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months. ( 1 ) Limitations of Use Not shown to improve quality of life, fatigue, or patient well-being. Not indicated for use: • As a substitute for transfusion in patients requiring immediate correction of anemia. • In patients not on dialysis.