Demonstrated protection from serious bacterial infections (SBIs)
Reduced health-related burdens
*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 12-month, prospective, open-label, single-arm, multicenter, phase 3 study that evaluated the efficacy and safety of BIVIGAM in 63 patients with PI. IV infusions were administered at doses of 300 to 800 mg/kg every 3 or 4 weeks for ≥3 months. Primary efficacy endpoint was the demonstration of a serious bacterial infection (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, unscheduled visits to the physician, and days hospitalized due to infection.1,4
References:
1BIVIGAM Prescribing Information. Boca Raton, FL: ADMA Biologics; 2019.
2Wasserman RL. A new intravenous immunoglobulin (BIVIGAM) for primary humoral immunodeficiency. Expert Rev Clin Immunol. 2014;10(3):325-337.
BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of 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
BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.
Thrombosis may occur following treatment with IGIV products, including BIVIGAM. Thrombosis may occur in the absence of known risk factors.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable.
In patients at risk of developing acute renal failure, renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output need to be monitored.
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy. Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
As hemolysis can develop subsequent to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.
Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Passive transfer of antibodies with IGIV treatment may yield positive serological testing results, with the potential for misleading interpretation.
Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in ≥ 5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increase, diarrhea, dizziness, and lethargy.
You are encouraged to report side effects of prescription drugs to ADMA Biologics at 1-800-458-4244 or the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
For more information about BIVIGAM, please see full Prescribing Information.
