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Gamunex‑C
Human Normal Immunoglobulin (igg) 10% Caprylate/chromatography Purified
$354.00
2.5g · 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 prescription medicine containing human immune globulin, mainly IgG antibodies. It is used to treat primary humoral immunodeficiency (PI) in patients aged 2 years and older and idiopathic thrombocytopenic purpura (ITP) in adults and children. It also treats chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It supplies antibodies that help defend against infectious agents and their toxins, although its exact effects in these conditions are 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 reported with Gamunex-C vary by the condition being treated. They include headache, fever, nausea, vomiting, diarrhea, abdominal pain, indigestion, back or joint pain, rash, bruising, chills, weakness, high blood pressure, increased cough, nasal or throat inflammation, sinusitis and asthma. Serious reactions that warrant immediate medical attention include severe allergic reactions, including anaphylaxis; inflammation of the membranes around the brain and spinal cord without infection (aseptic meningitis); breakdown of red blood cells, which can cause anemia; and acute lung injury related to transfusion. People with IgA deficiency who have antibodies against IgA are at greater risk of severe allergic reactions. Other serious risks requiring medical assessment include fluid overload and increased blood protein levels, which can change blood thickness and disrupt electrolyte balance. Because this medicine is made from human plasma, it may carry a risk of transmitting infectious agents.
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.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Gamunex‑C if you have had a hypersensitivity reaction to human immune globulin, including anaphylaxis or a severe reaction affecting the whole body. It must also not be used if you have IgA deficiency, antibodies against IgA and a history of hypersensitivity. Extra caution and monitoring are needed for: • IgA deficiency with antibodies against IgA, because of the increased risk of severe allergic reactions. • Increased blood protein levels, changes in blood thickness and electrolyte imbalances. • Aseptic meningitis, particularly with high doses or rapid infusion. • Breakdown of red blood cells (hemolysis), particularly with high doses or a non-O blood group. Close monitoring is especially important if you already have anemia or heart or lung problems. • Lung reactions, including transfusion-related acute lung injury, and fluid overload. • Age over 65, when particular care with administration is required. Gamunex‑C is made from human plasma and may carry a risk of transmitting infectious agents. Antibodies transferred during treatment may also interfere with antibody-based blood tests.
Interactions
Immunoglobulin treatment may temporarily reduce the immune response to live virus vaccines, including measles, mumps, rubella and chickenpox (varicella). Tell the doctor giving any vaccines if you have recently received Gamunex-C. Antibodies transferred during treatment 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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