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WE ARE ALWAYS HERE TO PROVIDE THE MOST UP-TO-DATE AND ACCURATE INFORMATION ON OUR PRODUCTS AND COMPANY

ADMA Biologics
Corporate Headquarters

ADMA Biologics
465 Route 17 South
Ramsey, NJ 07446

T: 201-478-5552
F: 201-478-5553

ADMA Biologics
Florida Campus

ADMA Biologics
5800 Park of Commerce Blvd, NW
Boca Raton, FL 33487

T: 561-989-5800
F: 561-989-5801

For General Inquiries, please contact:
Toll free: 800-458-4244, option 5
Email: CustomerService@admabio.com

For Medical Inquiries, please contact:
Toll free: 800-458-4244, option 2
Email: MA@admabio.com

For adverse events reporting, please contact:
Toll free: 800-458-4244, option 2
Email: PV@admabio.com

For product quality complaints, please contact:
Toll free: 800-458-4244, option 3
Email: PV@admabio.com

Contact the FDA (MedWatch):
Toll free: 1-800-FDA-1088
Fax: 1-800-FDA-0178

ADMA logo-4

VISIT CORPORATE WEBSITE, ADMABIOLOGICS.COM.

Indication

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®

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, 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.