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BIVIGAM met all primary endpoints1,2 

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Demonstrated protection from serious bacterial infections (SBIs)

  • 0.037 rate of SBIs per year*
  • During the 12-month study period, 2 serious acute bacterial infections occurred in 2 patients with an onset date between the first infusion of BIVIGAM and the first follow-up visit
    • 197 total infections were reported (3.7 infections PPPY)
    • 86% of patients were administered antibiotics (39.1 days PPPY)
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Reduced health-related burdens

  • Low rate of hospitalizations (0.21 days/PPPY)
    • 2 patients (3.4%) hospitalized for a total of 11 days (0.06%)
  • Fewer missed days of school/work (2.3 days/PPPY)
    • 21 patients (36%) with total of 122 days (0.6%)

*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.

Study Design

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).

Important Safety Information for BIVIGAM®


  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Use of immunoglobulin intravenous (IVIG) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients at risk of acute renal failure include those with any degree of preexisting renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs.
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
References: 1. BIVIGAM Prescribing Information. ADMA Biologics; 2022. 2. Wasserman RL. A new intravenous immunoglobulin (BIVIGAM®) for primary humoral immunodeficiency. Expert Rev Clin Immunol. 2014;10(3):325-337. 3. Wasserman RL, Church JA, Stein M, et al. Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency. J Clin Immunol. 2012;32(4):663-669.

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