For detailedEfficacyEnsure consistent therapy from infusion to infusion
The efficacy of GAMMAGARD LIQUID therapy 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 therapy 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:
Acute Serious Bacterial Infections for the Per-Protocol Analysis1
| Validated Infectionsa | Number of Events |
| Bacteremia/Sepsis | 0 |
| Bacterial meningitis | 0 |
| Osteomyelitis/Septic arthritis | 0 |
| Bacterial pneumonia | 0 |
| Visceral abcess | 0 |
| Mean number per subject per year | 0 |
| P-value [95% C|]b | P<0.0001 [0.00, 0.64] |
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a Acute serious bacterial infections were defined by the FDA and met specific diagnostic requirements. b The rate of validated infections was compared with a rate of 1 per subject per year, in accordance with recommendations of the FDA. |
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Fifty-seven of these patients were included in the pharmacokinetic analysis following the fourth infusion. Median IgG trough levels were maintained at 960 to 1120 mg/dL.1,2
Median IgG levels after infusion of GAMMAGARD LIQUID therapy and their 95% Cls1,2
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 therapy.
There were 896 non-serious adverse experiences, 258 of which were judged possibly or probably related to the infusion of GAMMAGARD LIQUID therapy; 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 [Immune Globulin Intravenous (Human)] 10% contains 100 mg/mL protein, composed of at least 98% gammaglobulin, including a broad spectrum of IgG antibodies against bacterial and viral agents.
Please see the detailed Important Risk Information and Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] for full prescribing details.
- GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% package insert. Westlake Village, CA. Baxter International Inc.; October 2009.
- Church JA, Leibl H, Stein MR, et al, and the US-PID-IGIV 10% Study Group. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. Journal of Clinical Immunology. 2006;26:388-395.
