What is Bivigam?
Bivigam is a 10% solution of Human Immune Globulin (IVIG) that is given by intravenous infusion (an injection into a vein) by a healthcare provider to treat adults and children aged 2 years of age and older with primary humoral immunodeficiency – which is an immune system that does not work correctly.
Primary humoral immunodeficiencies are characterized by defects in B lymphocytes – these are key players in our immune response. B cell abnormalities in primary humoral immunodeficiency classically result in decreased B cell numbers, impaired antibody production, or both, leading to an increased risk of infection, including severe infections.
Bivigam works by replacing missing immune globulin in people with primary humoral immunodeficiency, although the exact way it works is not understood.
Bivigam was FDA approved on December 20, 2012.
May cause hypersensitivity reactions. Do not use in people with a history of anaphylactic or severe systemic reactions to human immunoglobulin or in IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
Bivigam can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place. Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.
This medicine can also harm your kidneys, especially if you have kidney disease or you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.
Aseptic meningitis syndrome (inflammation of the lining of the brain) may occur rarely with infrequently with IGIV treatments including Bivigam. It usually begins within several hours to 2 days following IGIV treatment. Call your healthcare provider at once if you develop a severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, or vomiting.
Hemolysis (a breakdown in red blood cells) and delayed hemolytic anemia can develop following IGIV therapy (including Bivigam). Call your healthcare provider at once if you develop fatigue, increased heart rate, yellowing of skin or eyes, or dark-colored urine.
Fluid in the lungs (noncardiogenic pulmonary edema) related to the infusion (transfusion-related acute lung injury [TRALI]) has been reported following IVIG infusions, typically within 1 to 6 hours of treatment. Tell your doctor immediately if you have difficulty breathing, chest pain, blue lips or extremities, or develop a fever.
Immune globulin is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.
Before taking this medicine
You may not be able to use this medicine if:
- you have had an allergic reaction to an immune globulin or blood product
you have immune globulin A (IgA) deficiency with antibodies to IgA.
Bivigam can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you have ever had:
- heart problems, blood circulation problems, or "thick blood"
- a stroke or blood clot
- kidney disease
- an infection called sepsis
- if you use estrogens (birth control pills or hormone replacement therapy)
- if you have been on long-term bedrest or
- if you have a central intravenous (IV) catheter in place
- you are over the age of 65
- you are pregnant or intend to become pregnant
- you are breastfeeding.
Pregnancy and breastfeeding
The use of Bivigam in pregnant women has not been evaluated and it should be used only if needed. It is not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.
No human data are available about the use of Bivigam in breastfeeding women. Talk to your healthcare provider about the risks.
How is Bivigam administered?
Bivigam is given as a slow infusion into a vein, usually once every 3 to 4 weeks. A healthcare provider will give you this injection.
- Drink plenty of liquids while you are using Bivigam to help improve your blood flow and keep your kidneys working properly.
- You may need frequent blood or urine tests.
- This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using IGIV.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Bivigam injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What are the side effects of Bivigam?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.
Bivigam may cause serious side effects. Call your doctor at once if you have:
- signs of a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness
symptoms of dehydration --feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath
lung problems--chest pain, trouble breathing, blue-colored lips, fingers, or toes
signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light or
signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling, and warmth or discoloration in an arm or leg.
Common side effects of Bivigam affecting 5% or more people may include:
- infusion site reactions (pain, swelling, burning, or irritation where the IV needle was inserted)
- sinusitis (stuffy nose, sinus pain)
- increased blood pressure
- lack of energy.
Other reported side effects include:
- back pain, joint pain
- fever, chills, sweating, warmth or tingling
- stomach pain
- fast heartbeats.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What should I avoid while using Bivigam?
Ask your doctor before receiving a "live" vaccine while using Bivigam. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
What other drugs will affect Bivigam?
Bivigam can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).
- Bivigam may have a short-term effect on your immune response to live virus vaccines, such as measles, mumps, rubella, and varicella. Talk to your doctor about the best time to be immunized.
- May also interfere with the results of certain laboratory tests.
Other drugs may affect Bivigam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Store at 2° to 8°C (36° to 46°F) for up to 36 months from date of manufacture. Do not freeze.
Within the first 24 months of shelf-life, the product may be stored for up to 4 weeks at ≤ 25°C (77°F). After 24 months, the product may be stored at ≤ 25°C up to 2 weeks, until expiry. After storage at room temperature product must be used or discarded.
Active: Purified, sterile, ready-to-use preparation of concentrated human immunoglobulin G (IgG) antibodies containing 100 ± 10 mg/mL protein, of which not less than 96% is human immunoglobulin obtained from source human plasma. Contains ≤ 200 µg/mL of IgA.
Inactive: Formulated in water for injection containing 0.100-0.140 M sodium chloride, 0.20-0.29 M glycine, 0.15–0.25% polysorbate 80, and pH 4.0–4.6.
Each plasma donation used for the manufacture of Bivigam is collected from FDA-licensed facilities and undergoes rigorous testing. Donations must test negative for hepatitis A, B, and C virus, HIV strains 1 and 2, Parvovirus B19 (B19 virus), and other pathogens.
ADMA Biologics, Inc.
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