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Gammaked
Immune Globulin (human)
$708.00
5GR · 1 vial
BrandBranded medicine· By Grifols
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5GR
0.1
FDA boxed warningThrombosis, renal dysfunction, and acute renal failure
Thrombosis may occur with immune globulin products, including GAMMAKED. 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 GAMMAKED 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. GAMMAKED does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable.
Thrombosis may occur with immune globulin products, including GAMMAKED. 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 Gammaked
Overview
Gammaked is a sterile injection containing human immune globulin, made from human plasma. It treats 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 IgG antibodies that act against a range of 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 condition and how Gammaked is given. They include headache, fever, nausea, diarrhea, vomiting, tiredness or weakness, chills, rash, bruising, stomach or back pain, indigestion, joint or muscle pain, and high blood pressure. Cough, a runny or inflamed nose, sore throat, asthma, sinusitis and other respiratory infections were also reported. With infusion under the skin, common side effects also include reactions at the infusion site, skin redness, allergic skin inflammation, migraine and depression. Contact a doctor immediately for a severe allergic reaction or anaphylaxis. People with IgA deficiency who have antibodies against IgA are at greater risk. Other serious reactions requiring prompt medical attention include aseptic meningitis (inflammation of the lining around the brain and spinal cord), breakdown of red blood cells that can cause anemia, acute lung injury, fluid overload, and increased blood protein levels that can thicken the blood and disturb electrolyte balance. The risk of red blood cell breakdown is higher in people with a non-O blood group. Gammaked is made from human plasma and may carry a risk of transmitting infectious agents, including viruses.
FDA boxed warning
Thrombosis, renal dysfunction, and acute renal failure
Thrombosis may occur with immune globulin products, including GAMMAKED. 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 GAMMAKED 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. GAMMAKED does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer GAMMAKED at the minimum concentration available and the minimum infusion rate practicable.
Thrombosis may occur with immune globulin products, including GAMMAKED. 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
Do not use Gammaked if you have had an anaphylactic or severe whole-body reaction to human immunoglobulin, or if you have IgA deficiency with antibodies against IgA and a history of hypersensitivity. Gammaked can cause severe allergic reactions. Epinephrine must be immediately available during treatment. Other risks include increased blood protein levels, changes in blood viscosity, electrolyte imbalances, aseptic meningitis, breakdown of red blood cells (hemolysis), acute lung injury and fluid overload. Close monitoring for hemolysis is especially important if you have existing anemia, heart problems or lung problems. People with a non-O blood group are also at increased risk of hemolysis. Extra care with infusion speed is required in people over 65. Gammaked must not be given under the skin to patients with immune thrombocytopenic purpura (ITP), because of the risk of a collection of blood under the skin (hematoma). Gammaked is made from human plasma and may transmit infectious agents, including viruses and agents associated with Creutzfeldt-Jakob disease. Transferred antibodies may interfere with antibody-based blood tests.
Interactions
Gammaked may temporarily interfere with the immune response to live virus vaccines, including measles, mumps, rubella and chickenpox (varicella). Tell the clinician giving your vaccination if you have recently received Gammaked. Gammaked and heparin must not be given at the same time through the same infusion channel because they are incompatible. Gammaked should be administered separately from other medicines and must not be mixed with intravenous immune globulin products from other manufacturers. Antibodies transferred through Gammaked may affect the results of antibody blood tests. Tell your doctor about your Gammaked treatment when these tests are planned.
Using Gammaked
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 GAMMAKED (IMMUNE GLOBULIN (HUMAN)) INJECTION [KEDRION BIOPHARMA, INC.] (DailyMed, retrieved 19 September 2026).
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