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Gamunex

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Gamunex

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Sensitivity

Severe hypersensitivity reactions may occur. In case of hypersensitivity, IGIV infusion should be immediately discontinued and appropriate treatment instituted. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reaction. (See Patient Counseling Information)

GAMUNEX (immune globulin intravenous (human) 10%) contains trace amounts of IgA (average 46 micrograms/mL). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. (See Patient Counseling Information)

Renal Failure

Assure that patients are not volume depleted prior to the initiation of the infusion of IGIV. Periodic monitoring of renal function 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 GAMUNEX (immune globulin intravenous (human) 10%) and again at appropriate intervals thereafter. If renal function deteriorates, discontinuation of the product should be considered. (See Patient Counseling Information) For patients judged to be at risk for developing renal dysfunction and/or at risk of developing thrombotic events, it may be prudent to reduce the amount of product infused per unit time by infusing GAMUNEX at a rate less than 8 mg IG/kg/min (0.08 mL/kg/min). (See Boxed Warning) (See DOSAGE AND ADMINISTRATION)

Hyperproteinemia

Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving IGIV therapy. The hyponatremia is likely to be a pseudohyponatremia as demonstrated by a decreased calculated serum osmolality or elevated osmolar gap. Distinguishing true hyponatremia from pseudohyponatremia is clinically critical, as treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a disposition to thromboembolic events. [45]

Thrombotic Events

Thrombotic events have been reported in association with IGIV [33,34,35]. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization and/or known or suspected hyperviscosity. The potential risks and benefits of IGIV should be weighed against those of alternative therapies for all patients for whom IGIV administration is being considered. Baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.

Aseptic Meningitis Syndrome (AMS)

An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with Immune Globulin Intravenous (Human) treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. [25-27]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, 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. It appears that patients with a history of migraine may be more susceptible. (See Patient Counseling Information)

Hemolysis

Immune Globulin Intravenous (Human) (IGIV) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis.[28,29,30] Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. IGIV recipients should be monitored for clinical signs and symptoms of hemolysis. [31] If signs and/or symptoms of hemolysis are present after IGIV infusion, appropriate confirmatory laboratory testing should be done. (See Patient Counseling Information)

Transfusion-related Acute Lung Injury (TRALI)

There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] in patients administered IGIV.[32] TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1-6 hrs after transfusion. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support.

IGIV recipients should be monitored for pulmonary adverse reactions (See Patient Counseling Information) If TRALI is suspected, appropriate tests should be performed for the presence of anti-neutrophil antibodies in both the product and patient serum.

Volume Overload

The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

General

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 (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 Talecris Biotherapeutics, Inc. [1-800-520-2807]. The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient (See Patient Counseling Information)

Laboratory Tests

If signs and/or symptoms of hemolysis are present after IGIV infusion, appropriate confirmatory laboratory testing should be done.

If TRALI is suspected, appropriate tests should be performed for the presence of anti-neutrophil antibodies in both the product and patient serum.

Because of the potentially increased risk of thrombosis, baseline assessment of blood viscosity should be considered in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.

Use In Specific Populations

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with GAMUNEX (immune globulin intravenous (human) 10%) . It is not known whether GAMUNEX (immune globulin intravenous (human) 10%) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GAMUNEX (immune globulin intravenous (human) 10%) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

GAMUNEX (immune globulin intravenous (human) 10%) has not been evaluated in nursing mothers.

Pediatric Use

Treatment of Primary Immunodeficiency

GAMUNEX (immune globulin intravenous (human) 10%) was evaluated in 18 pediatric subjects (age range 0-16 years). Twenty-one percent of PI subjects (Study 100175) exposed to GAMUNEX (immune globulin intravenous (human) 10%) were children. Pharmacokinetics, safety and efficacy were similar to those in adults with the exception that vomiting was more frequently reported in pediatrics (3 of 18 subjects). No pediatric-specific dose requirements were necessary to achieve serum IgG levels.

One subject, a 10-year-old boy, died suddenly from myocarditis 50 days after his second infusion of GAMUNEX (immune globulin intravenous (human) 10%) . The death was judged to be unrelated to GAMUNEX (immune globulin intravenous (human) 10%) .

Treatment of Idiopathic Thrombocytopenic Purpura

GAMUNEX (immune globulin intravenous (human) 10%) was evaluated in 12 pediatric subjects with acute ITP. Twenty-five percent of the acute ITP subjects (Study 100176) exposed to GAMUNEX (immune globulin intravenous (human) 10%) were children. Pharmacokinetics, safety and efficacy were similar to those in adults with the exception that fever was more frequently reported in pediatrics (6 of 12 subjects). No pediatric-specific dose requirements were necessary to achieve serum IgG levels.

Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

The safety and effectiveness of GAMUNEX (immune globulin intravenous (human) 10%) has not been established in pediatric subjects with CIDP.

Geriatric Use

Patients > 65 years of age may be at increased risk for developing certain adverse reactions such as thromboembolic events and acute renal failure. (See Boxed Warning, WARNINGS and PRECAUTIONS) Clinical studies of GAMUNEX (immune globulin intravenous (human) 10%) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Table 11: Clinical Studies of GAMUNEX (immune globulin intravenous (human) 10%) by Age Group

Clinical Study Indication Number of Subjects
<65 years ≥ 65 years
100175 PI 78 9
100152 PI 18 0
100174 PI 20 0
10039 PI 19 0
100213 ITP 22 6
100176 ITP 44 4
10038 ITP 18 3
100538 CIDP 44 15

REFERENCE

25. Casteels-Van Daele, M., et al., Intravenous immune globulin and acute aseptic meningitis [letter]. N Engl J Med, 1990. 323(9): p. 614-5.

26. Kato, E., et al., Administration of immune globulin associated with aseptic meningitis [letter].Jama, 1988. 259(22): p. 3269-71.

27. Scribner, C.L., et al., Aseptic meningitis and intravenous immunoglobulin therapy [editorial; comment]. Ann Intern Med, 1994. 121(4): p. 305-6.

28. Copelan EA, Stohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26: 410-412

29. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig. Blood 1993;15:3789

30. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle & Nerve 1997; 20:1142-1145.

31. Kessary-Shoham H. Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced ecrythrocyte sequestration. J Autoimmune 1999; 13:129-135.

32. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001:41:264-268.

33. Dalakas MC. High-dose intravenous Immunoglobulin and serum viscosity: risk of precipitating thromboembolic events.Neurology, 44:223-226.

34. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients.Lancet 1986;2:217-218.

35. Wolberg AS, Kon RH, Monroe DM, Hjoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000; 65,30-34.

45. Steinberger, B. A., Ford, S. M., Coleman, T. A. Intravenous Immunoglobulin Therapy Results in Post-infusional Hyperproteinemia, Increased Serum Viscosity, and Pseudohyponatremia. Am J Hematol 73:97-100 (2003)

Last reviewed on RxList: 10/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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