Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.16,18 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. *
See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections for important information intended to reduce the risk of acute renal failure.
*GAMMAGARD S/D does not contain sucrose.
GAMMAGARD S/D, Immune Globulin Intravenous (Human) is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. (See DESCRIPTION section). Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.
GAMMAGARD S/D, Immune Globulin Intravenous (Human), should only be administered intravenously. Other routes of administration have not been evaluated.
Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine should be available for treatment of any acute anaphylactoid reactions.
GAMMAGARD S/D contains only trace amounts of IgA (= 2.2 µg/mL in a 5% solution). GAMMAGARD S/D is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern and it should be given with caution to patients with antibodies to IgA or IgA deficiencies, that are a component of an underlying primary immunodeficiency disease for which IGIV therapy is indicated. 7,19 In such instances, a risk of anaphylaxis may exist despite the fact that GAMMAGARD S/D contains only trace amounts of IgA.
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women, or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.
There is clinical evidence of a possible association between Immune Globulin Intravenous (Human) [IGIV] administration and the potential for the development of thrombotic events. The exact cause of this is unknown; therefore, caution should be exercised in the prescribing and infusion of IGIV in patients with a history of and predisposing factors towards cardiovascular disease or thrombotic episodes. 20-25; 33-38 Analysis of adverse event reports13,37 has indicated that a rapid rate of infusion may be a risk factor for vascular occlusive events.
An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with Immune Globulin Intravenous (Human) [IGIV] treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to two days following IGIV treatment. It is characterized by symptoms and signs including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per cu.mm., predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. Patients exhibiting such symptoms and signs should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently in association with high dose (2 g/kg) IGIV treatment.
Assure that patients are not volume depleted prior to the initiation of the infusion of IGIV.
Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure. Renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, should be assessed prior to the initial infusion of GAMMAGARD S/D and again at appropriate intervals thereafter. If renal function deteriorates, discontinuation of the product should be considered.
For patients judged to be at risk for developing renal dysfunction, it may be prudent to reduce the amount of product infused per unit time by infusing GAMMAGARD S/D at a rate less than 4 mL/kg/Hr (<3.3 mg IG/kg/min) for a 5% solution or at a rate less than 2 mL/kg/Hr (< 3.3 mg IG/kg/min) for a 10 % solution.
Certain components used in the packaging of this product contain natural rubber latex.
INFORMATION FOR PATIENTS
Patients should be instructed to immediately report symptoms of decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (which may suggest kidney damage) to their physician.
See DOSAGE AND ADMINISTRATION section.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with GAMMAGARD S/D, Immune Globulin Intravenous (Human). It is also not known whether GAMMAGARD S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GAMMAGARD S/D should be given to a pregnant woman only if clearly needed.