Contraindications
- GAMMAGARD LIQUID is contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to human IG, and IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID.
- GAMMAGARD LIQUID ERC is contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD LIQUID ERC.
Warnings and Precautions
Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.
Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Acute renal failure has been reported in association with GAMMAGARD LIQUID. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. It is critical to distinguish true hyponatremia from pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events.
Thrombosis: Has been reported to occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Aseptic Meningitis Syndrome: Has been reported with use of IG. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. The syndrome usually begins within several hours to two days following IG treatment.
Hemolysis: GAMMAGARD LIQUID and GAMMAGARD LIQUID ERC contain blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.
Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema has been reported with IV-administered IG, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.
Transmissible Infectious Agents: Because GAMMAGARD LIQUID and GAMMAGARD LIQUID ERC are made from human plasma, they may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID.
Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.
Adverse Reactions
GAMMAGARD LIQUID
IV administration: The serious adverse reaction seen during IV clinical trials was aseptic meningitis. The most common adverse reactions observed in ≥5% of patients in clinical trials were headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.
Subcutaneous administration: The most common adverse reactions observed in ≥5% of patients in clinical trials were infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.
GAMMAGARD LIQUID ERC
The safety of GAMMAGARD LIQUID ERC in patients with primary humoral immunodeficiency (PI) is supported by two clinical studies conducted on GAMMAGARD LIQUID. No clinical studies have been conducted using GAMMAGARD LIQUID ERC.
IV administration: The most common adverse reactions observed in ≥5% of patients in study 1 were headache, fatigue, pyrexia, chills, nausea, pain in extremity, diarrhea, migraine, vomiting, dizziness, urticaria, cough, asthma, oropharyngeal pain, infusion site extravasation, arthralgia, rash, myalgia, pruritus, and cardiac murmur.
Subcutaneous administration: The most common adverse reactions observed in ≥5% of patients in study 2 were infusion site (local) event, headache, pyrexia, fatigue, heart rate increased, abdominal pain upper, vomiting, arthralgia, nausea, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous ulcer, migraine, oropharyngeal pain, and pain in extremity.
Drug Interactions
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).
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