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BIVIGAM is a purified, sterile, sugar-free, glycine-stabilized liquid solution containing 10% IgG (100 mg/mL) for intravenous infusion1


300 to 800 mg/kg every 3 weeks or 4 weeks*

*Frequency/amount of IgG therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.


Initial infusion rate
(for first 10 minutes)

0.5 mg/kg/min
(0.005 mL/kg/min)

Maintenance infusion rate
(if tolerated)

Increase gradually
every 20 minutes (if tolerated)
by 0.8 mg/kg/min up to 6 mg/kg/min

  • Dose may be adjusted to achieve trough total IgG concentrations between 500 mg/dL and 600 mg/dL as the target
  • Frequency of adverse drug reactions to IVI may increase with the infusion rate
    • No adverse drug reactions: Infusion rate for subsequent infusions can be slowly increased to the maximum rate
    • Adverse drug reactions: Reduce the infusion rate for subsequent infusions
  • Monitor patient vital signs throughout the infusion
    • Slow or stop the infusion if adverse reactions occur
    • If symptoms subside promptly, the infusion may be resumed at a lower rate/comfortable rate for patient
  • Ensure that patients with preexisting renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer BIVIGAM at the minimum infusion rate practicable, and consider discontinuation of administration if renal function deteriorates


  • Once vial is entered, use promptly
  • Store at 2-8 °C (36-46 °F) for up to 36 months from the date of manufacture
  • Do not freeze
  • Within the first 24 months of shelf-life, product may be stored up to 4 weeks at ≤ 25 °C (77 °F). After storage at room temperature product must be used or discarded




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.
Reference: 1. BIVIGAM Prescribing Information. ADMA Biologics; 2022.

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