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WHEN TREATING PATIENTS WITH PI
IN A 1-YEAR STUDY OF PATIENTS WITH PI
*Target was 1 SBI/year; 99% CI of 0.136 SBI/patient/year. †Of 63 adult patients enrolled in this study, 58 were included in efficacy analysis.
PPPY=per patient per year.
A 52-week, prospective, open-label, single-arm, multicenter, phase 3 study that evaluated the efficacy and safety of BIVIGAM in 63 adult and pediatric patients with PI. Patients received regular IVIG replacement therapy with a stable dose between 300 and 800 mg/kg for at least 3 months prior to participation. Patients received BIVIGAM infusion every 3 or 4 weeks (both the dose and schedule depending on their prior therapy) for approximately 1 year. Primary efficacy endpoint was the demonstration of an SBI rate of less than 1.0 per person-year during the 52-week treatment period. Secondary efficacy endpoints included number of missed days of work/school/activity due to infection and days hospitalized due to infection.1,3
BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of patients with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID).
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE