lumasiran

FDA Drug Profile — OXLUMO

Drug Details

Generic Name
lumasiran
Brand Names
OXLUMO
Application Number
NDA214103
Sponsor
Alnylam Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
LUMASIRAN SODIUM

Indications and Usage

1 INDICATIONS AND USAGE OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (12.1) , Clinical Studies (14.1 , 14.2 , 14.3) ] . OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. ( 1 )