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Preparation and handling1

BIVIGAM is a clear or slightly opalescent, colorless to pale yellow solution. Inspect BIVIGAM visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or turbid, or contains particulate matter.

  • Allow refrigerated product to come to room temperature before use
  • Do not freeze or heat. Do not use any solution that has been frozen or heated
  • DO NOT SHAKE
  • Do not mix BIVIGAM with other IGIV products or other intravenous medications. If large doses of BIVIGAM are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags and infused
  • Do not dilute BIVIGAM
  • BIVIGAM contains no preservatives. BIVIGAM vial is for single use only. Any vial of BIVIGAM that has been entered should be used promptly and any unused portion should be discarded immediately. Do not reuse or save for future use
  • Maintain BIVIGAM at room temperature during administration
  • Do not use after expiration date

RECOMMENDED DOSING AND ADMINISTRATION

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


DOSING

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.

VIAL SIZE

5 g/50 mL

SINGLE-USE

non-latex,
tamper-evident vial





Recommended Infusion Rates for BIVIGAM1

Indication Initial Infusion Rate
(for first 10 minutes)
Maintenance Infusion Rate
(if tolerated)
PI 0.5 mg/kg/min
(0.005 mL/kg/min)
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 target1
  • Frequency of adverse drug reactions to IGIV 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

References:

1BIVIGAM Prescribing Information. Boca Raton, FL: ADMA Biologics 2019

IgG=immunoglobulin Class G

Important Safety Information for BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid]

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

  • 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, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
  • Use of immune globulin intravenous (IGIV) 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 pre-existing 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.

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.