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Side Effects of IVIG

The majority of side effects with IVIG are mild, transient, and self-limited and do not require discontinuation of therapy. Reactions are more likely to occur in patients who are receiving IVIG for the first time, or who are receiving a new formulation.1

Serious adverse events such as:

have been reported to occur in association with IVIG3,4

The most common side effects are2:

Most patients with these side effects can be helped by slowing down the rate of infusion. Premedication with acetaminophen, antihistamines, or occasionally steroids can also help decrease side effects.3

Important Risk Information for GAMMAGARD LIQUID

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.

Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Components used in the packaging of this product are latex-free.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).

Please see the Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] for full prescribing details.

  1. Bonilla, Francisco. Intravenous immunoglobulin: Adverse reactions and management. J Allergy Clin Immunol 122(6): 1238-1239
  2. Bertorini TE, Nance AH, Horner LT, Greene , Gelfand M, Jaster JH. Complications of intravenous gammaglobulin in neuromuscular and other diseases. Muscle Nerve 1996;19: 388-391.
  3. Ippoliti C, Williams LA, Huber S. Toxicity of rapidly infused concentrated intravenous immune globulin. Clinical Pharmacology 1992;11:1022-1026.
  4. GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% package insert. Westlake Village, CA. Baxter International Inc.; October 2009.