The US Food and Drug Administration has approved an expanded indication for immune globulin intravenous, human–slra 10% liquid (ASCENIV) to include pediatric patients aged 2 years and older with primary humoral immunodeficiency, according to a press release from ADMA Biologics. The approval was based on a supplemental biologics license application and represented the final study report for the required pediatric assessment.

ASCENIV was previously indicated for patients aged 12 years and older with primary humoral immunodeficiency. The updated labeling extends the indication to younger pediatric patients.

ASCENIV is a plasma-derived, polyclonal intravenous immune globulin. It is produced using a patented plasma donor screening method and a plasma pooling approach that includes respiratory syncytial virus plasma from selected donors. The product was approved by the US Food and Drug Administration in April 2019.

ASCENIV carries warnings for thrombosis, renal dysfunction, and acute renal failure. Risk factors for thrombosis include hypercoagulable conditions and cardiovascular risk factors. In patients at risk of renal dysfunction or renal failure, monitoring of renal function is recommended during treatment.

Common adverse events included headache, sinusitis, diarrhea, viral gastroenteritis, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. Other reported risks included hypersensitivity reactions, aseptic meningitis syndrome, hemolytic anemia, and transfusion-related acute lung injury.

Source: ADMA Biologics