Gammagard Liquid, illustration of injection vial form (not a photo of the actual pack)

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Gammagard Liquid

Human Normal Immunoglobulin

Prescription required

$1326.00

10G/100ML · 10 vial

BrandBranded medicine· By Takeda

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5G/50ML

5g

10G/100ML

FDA boxed warningThrombosis, renal dysfunction and acute renal failure

Thrombosis may occur with immune globulin products, including GAMMAGARD LIQUID. 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. Thrombosis may occur in the absence of known risk factors.

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. 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. GAMMAGARD LIQUID does not contain sucrose..

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products including GAMMAGARD LIQUID. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.

For patients at risk of thrombosis, administer GAMMAGARD LIQUID 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 of hyperviscosity.

Read this with the rest of the clinical information

About Gammagard Liquid

Overview

Gammagard Liquid is a human immune globulin medicine containing purified immunoglobulin G (IgG) antibodies from human plasma. It is used to replace antibodies in adults and children aged two years and older with primary humoral immunodeficiency. In adults, it is also used as maintenance therapy to improve muscle strength and disability in multifocal motor neuropathy (MMN), and to improve nerve and muscle disability and impairment in chronic inflammatory demyelinating polyneuropathy (CIDP). It supplies antibodies that act against bacteria and viruses and may alter immune system activity, although its effects are not fully understood.

What it treats

- Primary humoral immunodeficiency (PI): replacement therapy in adults and children aged 2 years and older. - Multifocal motor neuropathy (MMN): maintenance therapy to improve muscle strength and disability in adults. - Chronic inflammatory demyelinating polyneuropathy (CIDP): therapy to improve neuromuscular disability and impairment in adults. Safety and effectiveness have not been studied in patients who have never received immunoglobulin therapy, and maintenance treatment has not been studied beyond 6 months.

Safety information

Side effects

Common side effects vary by the condition being treated and how Gammagard Liquid is given. In primary immunodeficiency studies, common effects with intravenous infusion included headache, tiredness, fever, nausea, chills or shaking, vomiting, diarrhoea, dizziness, migraine, rash, itching, and muscle, joint or limb pain. With infusion under the skin, common effects included infusion-site reactions, headache, tiredness, fever, nausea, vomiting, upper abdominal pain, diarrhoea, increased heart rate and increased blood pressure. Local reactions included pain, redness, swelling, itching and bruising. In multifocal motor neuropathy studies, common effects included headache, chest discomfort, muscle spasms, muscle weakness, nausea, throat pain and limb pain. In chronic inflammatory demyelinating polyneuropathy studies, common effects included headache, fever, dizziness, migraine, sleepiness, tremor, vomiting, chills, upper abdominal pain and limb pain. Anaemia, low white blood cell counts and increased blood creatinine were also reported. Serious side effects require immediate medical attention. These include severe allergic reactions, including anaphylaxis; blood clots, including clots in the lungs; kidney injury or failure; destruction of red blood cells causing anaemia; and acute lung injury causing severe breathing difficulty. Severe allergic reactions can occur even if previous immune globulin treatment was tolerated. Blood clots can occur without known risk factors. Contact a doctor immediately for severe headache with a stiff neck, fever, drowsiness, sensitivity to light, painful eye movements, nausea or vomiting, as these may indicate aseptic meningitis. Blurred vision was also reported as a serious reaction. Increased blood protein, thicker blood and low blood sodium may occur. Because Gammagard Liquid is made from human blood, it carries a potential risk of transmitting infectious agents.

FDA boxed warning

Thrombosis, renal dysfunction and acute renal failure

Thrombosis may occur with immune globulin products, including GAMMAGARD LIQUID. 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. Thrombosis may occur in the absence of known risk factors.

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. 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. GAMMAGARD LIQUID does not contain sucrose..

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products including GAMMAGARD LIQUID. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.

For patients at risk of thrombosis, administer GAMMAGARD LIQUID 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 of hyperviscosity.

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

• Seek immediate medical attention for severe trouble breathing, especially with fever. • Seek immediate medical attention for a severe headache with a stiff neck, drowsiness, fever, sensitivity to light, painful eye movements, nausea or vomiting. • Seek immediate medical attention for blurred vision.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not use Gammagard Liquid if you have had anaphylaxis or another severe whole-body allergic reaction to human immune globulin. It must also not be used if you have IgA deficiency, antibodies against IgA and a history of allergic reactions. Severe allergic reactions can occur even if previous immune globulin treatment was tolerated. If a reaction occurs, the infusion must be stopped immediately and appropriate treatment given. Extra caution and monitoring are needed if you have kidney problems, diabetes, dehydration, sepsis, abnormal blood proteins, are over 65, or take medicines that can damage the kidneys. Kidney injury or failure can occur. Your healthcare team should ensure adequate hydration and check kidney function and urine output, particularly if you are at increased risk. Blood clots can occur, even without known risk factors. Tell your prescriber if you have a history of blood clots, a clotting disorder, prolonged immobility, thickened blood, cardiovascular risk factors, an indwelling central vascular catheter, or use estrogen. Older age also increases the risk. Other serious risks include aseptic meningitis, breakdown of red blood cells causing anemia, and acute lung injury. Increased blood protein levels, thickened blood and low blood sodium readings may also occur. Monitoring may be needed for these complications. Gammagard Liquid is made from human blood and may carry a risk of transmitting infectious agents. It can also interfere with some blood tests, including antibody tests and certain tests for fungal infections. Tell the clinician interpreting your tests that you have received it.

Interactions

Gammagard Liquid can temporarily reduce the immune response to live virus vaccines. This may last up to 6 months for mumps, rubella and chickenpox (varicella) vaccines, and a year or longer for the measles vaccine. Tell the doctor giving your vaccines about recent Gammagard Liquid treatment so they can take appropriate precautions.

Using Gammagard Liquid

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 GAMMAGARD LIQUID (IMMUNE GLOBULIN INFUSION (HUMAN)) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] (DailyMed, retrieved 19 September 2026).

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