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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.1
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).1
Primary immunodeficiency disease consists of more than 350 rare, chronic disorders involving a compromised or incomplete immune system. These disorders are not contagious and often present at birth (due to hereditary or genetic defects) and can impact any race, age, or gender. While some disorders impact multiple components of the immune system, others can impact only one, resulting in the inability of the body to fight infection.2
Exact prevalence is unknown but, in the United States, it is estimated that 1 in 2000 children and 1 in 600 households (or an estimated 150,000 to 360,000 people) are diagnosed with PI.3
Those suffering with PI often get one infection after another. These infections may never really improve as expected and may reoccur over time. In more severe forms of PI, even certain infections considered "less serious" in individuals with normal immune systems, may cause serious, life-threatening infections in those with PI.1
Also, certain PIs are associated with immune system disorders such as anemia, arthritis, or autoimmune diseases. Other PIs increase the risk of cancer, stunt growth, or impact the heart, digestive tract, or the nervous system.1
In a survey of patients with primary immunodeficiency, the Immune Deficiency Foundation (IDF) "National Survey of Patients: 2008," only 10% of the responding 1030 patients never missed any day of work or school prior to diagnosis. In the same survey, patients reported that they missed an average of 36.8 days of work or school prior to diagnosis.4
Excerpted from Jeffrey Modell Foundation.
If left untreated, PI can lead to serious health issues. If someone in your family has PI it is important to have other family members checked for signs and symptoms and evaluated for PI as soon as possible.
This information is not intended to be a substitute for professional medical care. You should consult your family physician or pediatrician for specific information on the diagnosis, treatment, and clinical care of patients with PI.
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.
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 negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
For more information about BIVIGAM, please see full Prescribing Information.