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Important Safety Information for BIVIGAM®
BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, 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: RISK OF BLOOD CLOTS (THROMBOSIS), POOR KIDNEY FUNCTION, AND KIDNEY FAILURE
- Blood clots may happen with intravenous immune globulin products, including BIVIGAM. Before taking BIVIGAM, talk to your doctor if you:
- Are of advanced age
- Are unusually sedentary (long periods of sitting down or inactive)
- Have a history of blood clots in the veins or arteries, cardiovascular (heart) problems or previous history of stroke
- Are taking estrogen-containing medicines (birth control pills, hormone replacement therapy)
- Have a permanent intravenous (IV) catheter
- Have hyperviscosity (poor blood flow) of the blood (diseases such as multiple myeloma or other causes of elevated proteins in the blood)
- Kidney problems, kidney failure, and death are more common in people who are taking human immune globulin products, especially those containing sucrose (sugar). BIVIGAM does not contain sucrose. Let your doctor know if you have kidney disease or diseases with kidney involvement, have a history of diabetes, or are older than 65 years of age. Your doctor should check your hydration level, blood infection risk, protein levels, and if you are taking any drugs that may damage your kidneys.
- If you are at risk for blood clots or kidney problems, your doctor should adjust your starting dose of BIVIGAM and monitor your blood flow.
What is BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid]?
BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is a prescription medicine to help adults and adolescents (12 to 17 years old) with primary immunodeficiency fight and prevent infections. BIVIGAM is for intravenous administration only. BIVIGAM is made from healthy human blood/plasma.
Who should not use BIVIGAM?
BIVIGAM should not be used if you had a severe allergic reaction to human immune globulin or if you have been told by a doctor that you are immunoglobulin A (IgA) deficient and have developed antibodies to IgA and hypersensitivity after exposure to a previous plasma product.
What are possible warnings and precautions with taking BIVIGAM?
If you take BIVIGAM or a similar immune globulin product, you could experience a serious and life-threatening blood clot (thromboembolism). Thrombosis may occur even if you do not have any risk factors.
Your doctor should perform blood tests to see if you are at risk for poor blood flow (hyperviscosity). These tests will check for the presence of other proteins in the blood that might put you at risk of blood clots.
Kidney problems or failure. Kidney problems, kidney failure, and death may occur with use of human immune globulin products. If your doctor determines that you are at risk of kidney problems, they should monitor your with routine blood and urine tests.
Aseptic meningitis syndrome (AMS). Aseptic meningitis is a non-infectious inflammation of the membranes that cover the brain. It causes a severe headache, which may occur with human immune globulin treatment, including BIVIGAM. AMS usually happens within a few hours to 2 days after treatment. AMS is more commonly associated with higher doses of treatment and/or after rapid infusion. Your doctor may perform a neurological exam, including spinal tap (sampling fluid which surrounds the spinal cord) to evaluate your condition and to rule out other causes of meningitis.
People taking human immune globulin products, including BIVIGAM, may experience hyperproteinemia (high levels of protein in the blood), hyponatremia (low levels of sodium in the blood), and hyperviscosity (poor blood flow). Your doctor may perform certain blood tests and monitor you to minimize any of the above risks.
Hemolysis. Hemolysis refers to the destruction of red blood cells. Immune globulin products, including BIVIGAM, may contain certain antibodies that can result in the rupturing of red blood cells. Your doctor should monitor you for signs and symptoms of hemolysis. People taking human immune globulin products may experience lung-related side effects, including transfusion-related acute lung injury (TRALI). TRALI is a rare but serious syndrome characterized by sudden acute respiratory distress following transfusion. Your doctor should monitor you for lung-related side effects and may conduct tests to check for the presence of certain white blood cells (anti-neutrophils) in the drug or your blood.
Transmissible infectious agents. Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Your doctor will report to the manufacturer any cases of suspected infections spread by the product.
Interference with lab tests. Because BIVIGAM contains a variety of antibodies that are infused into your body, blood tests may provide misleading interpretations. Be sure to tell your doctor, nurse, or lab technician that you are using BIVIGAM.
Interactions with medicines. BIVIGAM can make vaccines (like measles, mumps, rubella, and chicken pox vaccines) less effective in your body. Before you get any vaccines, tell your healthcare provider that you take BIVIGAM.
What are other possible side effects of BIVIGAM?
In clinical studies of BIVIGAM, some patients experienced the following serious side effects:
- Vomiting
- Dehydration
The most common side effects included:
- Headache
- Fatigue
- Reaction at the site of infusion
- Nausea
- Sinus inflammation (sinusitis)
- Blood pressure increase
- Diarrhea
- Dizziness
- Loss of energy (lethargy)
These are not all the possible side effects of BIVIGAM. Talk to your healthcare provider about any side effect that bothers you or that does not go away.
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.