clinical efficacyThe efficacy of GAMMAGARD LIQUID 10% has been demonstrated in a pivotal open-label clinical study of 61 patients (58 evaluable) with primary immunodeficiency.
These patients were treated with 300–600 mg/kg GAMMAGARD LIQUID every 21–28 days over 12 months. The primary efficacy endpoint of the study was the annualized rate of specified acute serious bacterial infections; there were none in any of the treated patients.1 See chart below:
Secondary efficacy endpoints included the incidence of other specified validated bacterial infections. There was one reported incidence of urinary tract infection, one of gastroenteritis, 2 of otitis media, no lower respiratory tract infections and no hospitalizations secondary to all validated infection complications.
Adverse experiences included 15 serious events in 8 subjects; two events—both in a single subject—were deemed to be possibly related to the infusion of GAMMAGARD LIQUID.
There were 896 non-serious adverse experiences, 258 of which were judged possibly or probably related to the infusion of GAMMAGARD LIQUID; of these 136 were mild, 106 moderate, and 16 severe—none of the 16 led to hospitalization. For the most current information on adverse event data, please see GAMMAGARD LIQUID Prescribing Information or contact Medical Affairs at 866-424-6724.
GAMMAGARD LIQUID 10% contains 100 mg/mL protein, composed of at least 98% gammaglobulin, including a broad spectrum of IgG antibodies against bacterial and viral agents.