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Gamunex‑C
Human Normal Immunoglobulin (igg) 10% Caprylate/chromatography Purified
$142.00
0.1 · 1 vial
BrandBranded medicine· By Grifols
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FDA boxed warningThrombosis, renal dysfunction, and acute renal failure
Thrombosis may occur with immune globulin products, including GAMUNEX ® -C FlexBag. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
For patients at risk of thrombosis, administer GAMUNEX-C FlexBag 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.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C FlexBag does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer GAMUNEX-C FlexBag at the minimum concentration available and the minimum infusion rate practicable.
Thrombosis may occur with immune globulin products, including GAMUNEX-C FlexBag. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
About Gamunex‑C
Overview
Gamunex-C is a human immune globulin (IgG) medicine made from human plasma. It is used to treat primary humoral immunodeficiency (PI) in patients aged 2 years and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It supplies antibodies against bacteria, viruses and other infectious agents and their toxins, although exactly how it works in these conditions is not fully understood.
What it treats
- Primary humoral immunodeficiency (PI) in patients aged 2 years and older. - Idiopathic thrombocytopenic purpura (ITP) in adults and children. - Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
Safety information
Side effects
Common side effects vary by the condition being treated. They include headache, fever, nausea, vomiting, rash, chills, increased cough, runny nose, sore throat, asthma, diarrhea, sinus inflammation, bruising, abdominal or back pain, indigestion, high blood pressure, joint pain and weakness. Serious side effects that warrant prompt medical attention include severe allergic reactions, including anaphylaxis; aseptic meningitis (inflammation around the brain and spinal cord); breakdown of red blood cells, which can cause anemia; acute lung injury; and fluid overload. Increased blood protein levels can also change blood thickness and disrupt electrolyte balance. Seek emergency medical help for a severe allergic reaction. People with IgA deficiency who have antibodies against IgA are at greater risk of severe allergic reactions. Because Gamunex-C is made from human plasma, it may carry a risk of transmitting infectious agents. Transferred antibodies can also interfere with some blood test results.
FDA boxed warning
Thrombosis, renal dysfunction, and acute renal failure
Thrombosis may occur with immune globulin products, including GAMUNEX ® -C FlexBag. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
For patients at risk of thrombosis, administer GAMUNEX-C FlexBag 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.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C FlexBag does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer GAMUNEX-C FlexBag at the minimum concentration available and the minimum infusion rate practicable.
Thrombosis may occur with immune globulin products, including GAMUNEX-C FlexBag. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
Before taking this medicine
Gamunex-C must not be used in people who have had an allergic reaction to human immune globulin, including anaphylaxis or a severe whole-body reaction. It must also not be used in people with IgA deficiency who have antibodies against IgA and a history of allergic reactions. People with IgA deficiency and antibodies against IgA are at greater risk of severe allergic reactions. Epinephrine must be immediately available during treatment. Caution and monitoring are needed for increased blood protein levels, changes in blood thickness, electrolyte imbalances, aseptic meningitis, red blood cell breakdown (hemolysis), acute lung injury and fluid overload. Hemolysis risk is greater in people with a non-O blood group; close monitoring is especially important in those with existing anemia, heart or lung problems. Extra caution is needed in people over 65. Gamunex-C is made from human plasma and may carry a risk of transmitting infectious agents. Transferred antibodies may also interfere with antibody-based blood tests.
Interactions
Antibodies in Gamunex-C may temporarily reduce the immune response to live virus vaccines, including measles, mumps, rubella and chickenpox (varicella). Tell the doctor giving any vaccination if you have recently received Gamunex-C. These antibodies can also affect the results of blood tests that check for antibodies. Tell your doctor about your treatment before these tests.
Using Gamunex‑C
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label GAMUNEX-C (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC] (DailyMed, retrieved 19 September 2026).
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