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WHEN TREATING PATIENTS WITH PRIMARY IMMUNODEFICIENCY (PI)

PROTECTION IS A BEAUTIFUL THING

ADMA Biologics is relentlessly committed to creating products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and developments that sets us apart.

We are proud to offer BIVIGAM to the many patients living with primary immunodeficiency (PI). Management of PI is a lifelong process and we want every patient who starts treatment with BIVIGAM to know we will be there for them every step of the way.

REINTRODUCING BIVIGAM
ADMA is focused on what matters most: safety, quality, and efficacy.

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Committed to Patients with Primary Immunodeficiency (PI)

Learn more on how BIVIGAM can help people living with primary immunodeficiency (PI) disorders.1

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About Primary Humoral Immunodeficiency (PI)

Nearly all of us get an infection once in a while - perhaps it's a minor cold, cough, or a cut that gets infected, or it may be something more serious like pneumonia.2

Most people expect to recover quickly from an infection. Our body's immune defenses (sometimes with help from certain medicines) can usually eliminate germs that cause infection and protect us against new germs in the future. Others are born with an immune system that is without certain defenses required to fight infections. This is called primary humoral immunodeficiency (PI).2

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How BIVIGAM Is Made Learn how BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is manufactured.

The human immunoglobulin is purified from source human plasma and processed using a modified classical Cohn-Oncley fractionation procedure. The Cohn-Oncley method is a multistep process of isolating immunoglobulins from plasma using different alcohol concentrations under specific conditions of temperature, pH, protein concentration and ionic strength at each step.1


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About ADMA Biologics
LogoUnited by passion. Driven by Innovation

Why does it matter?
Because patients are counting on us.


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References:

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

2National Institutes of Health. National Institute of Child Health and Human Development. Primary immunodeficiency: when the body's defenses are missing. Bethesda, MD: National Institutes of Health; 1999. https://babel.hathitrust.org/cgi/pt?id=pur1.32754069276255. Accessed November 13, 2017.

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.