"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
Acute Renal Dysfunction and Acute Renal Failure
Patients should not be volume depleted prior to the initiation of the infusion of Privigen™ (immune globulin intravenous) . Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk of developing acute renal failure. Renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, should be assessed before the initial infusion of Privigen™ (immune globulin intravenous) and at appropriate intervals thereafter. For patients judged to be at risk of developing renal dysfunction, Privigen™ (immune globulin intravenous) should be administered at the minimum rate of infusion practicable (see DOSAGE AND ADMINISTRATION). If renal function deteriorates, consider discontinuing Privigen™. (See Patient Counseling Information)
Aseptic Meningitis Syndrome (AMS)
AMS has been reported to occur infrequently with Privigen™ (immune globulin intravenous) and other IGIV treatments. The syndrome usually begins within several hours to 2 days following IGIV treatment. AMS is characterized by signs and symptoms 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 cubic millimeter, predominantly from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. Patients exhibiting such signs and symptoms 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 doses (2 g/kg) and/or rapid infusion of IGIV. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.2 (See Patient Counseling Information)
IGIV products can contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis.3-5 Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration (extravascular hemolysis) or intravascular RBC destruction (intravascular hemolysis).6
Hemolysis, possibly intravascular, occurred in two subjects treated with Privigen™ (immune globulin intravenous) in the ITP study. These cases resolved uneventfully. Six other subjects experienced hemolysis in the ITP study as documented from clinical laboratory data.
IGIV recipients should be monitored for clinical signs and symptoms of hemolysis (see Patient Counseling Information). If signs and/or symptoms of hemolysis are present after IGIV infusion, appropriate confirmatory laboratory testing should be performed. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving IGIV, adequate cross-matching should be performed to avoid exacerbating on-going hemolysis.
Transfusion-related Acute Lung Injury (TRALI)
There have been reports of noncardiogenic pulmonary edema in patients administered IGIV.7 TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1 to 6 hours following transfusion. IGIV recipients should be monitored for pulmonary adverse reactions (see Patient Counseling Information). Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support.
If TRALI is suspected, appropriate tests should be performed for the presence of antineutrophil antibodies in both the product and the patient's serum.
Thrombotic events have been reported with Privigen™ (immune globulin intravenous) and other IGIV treatments.8-10 Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable 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 in all patients for whom IGIV administration is being considered.
Because of the potentially increased risk of thrombosis, baseline assessment of blood viscosity should be considered in patients at risk of hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies.
Transmissible Infectious Agents
Privigen™ is made from human plasma. Products made from human plasma may contain infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent, 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 during manufacturing through pH 4 incubation, depth filtration, and virus filtration (see DESCRIPTION).
Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. 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 CSL Behring at 1-800-504-5434. (See Patient Counseling Information).
Interference With Laboratory Tests
After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs') test.
Interference With Live Virus Vaccines
Immunoglobulin administration may transiently impair the efficacy of live virus vaccines such as measles, mumps, and rubella. The immunizing physician should be informed so that appropriate measures may be taken (see DRUG INTERACTIONS, Patient Counseling Information).Use In Specific Populations
Pregnancy Category C. Animal reproduction studies have not been conducted with Privigen™ (immune globulin intravenous) . It is not known whether Privigen™ (immune globulin intravenous) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Privigen™ (immune globulin intravenous) should be given to pregnant women only if clearly needed. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.14,15
Privigen™ (immune globulin intravenous) has not been evaluated in nursing mothers.
Treatment of Primary Immunodeficiency
Privigen™ (immune globulin intravenous) was evaluated in 19 children and 12 adolescents with PI. There were no apparent differences in the safety and efficacy profiles as compared to adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. The safety and effectiveness of Privigen™ (immune globulin intravenous) has not been established in pediatric subjects with PI who are under the age of 3.
Treatment of Chronic Immune Thrombocytopenic Purpura
The safety and effectiveness of Privigen™ (immune globulin intravenous) has not been established in pediatric subjects with chronic ITP who are under the age of 15.
Privigen™ (immune globulin intravenous) should be used with caution in patients over 65 years of age who are judged to be at increased risk of developing renal insufficiency (see BOXED WARNING, WARNINGS and PRECAUTIONS). Recommended doses should not be exceeded, and the infusion rate selected should be the minimum practicable. Privigen™ (immune globulin intravenous) should be infused at a rate less than 2 mg/kg/min (0.02 mL/kg/min).
Clinical studies of Privigen™ (immune globulin intravenous) did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.
2. Gabor EP. Meningitis and skin reaction after intravenous
immune globulin therapy. Ann Intern Med 1997;127:1130.
3. Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26:410-412.
4. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig. Blood 1993;15:3789.
5. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle Nerve 1997;20:1142-1145.
6. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmun 1999;13:129-135.
7. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001;41:264-268.
8. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;44:223-226.
9. 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.
10. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000;65:30-34.
13. Siber GA, Werner BG, Halsey NA, et al. Interference of immune globulin with measles and rubella immunization. J Pediatr 1993;122:204-211.
14. Hammarström L, Smith CIE. Placental transfer of intravenous immunoglobulin. Lancet 1986;1:681.
15. Sidiropoulos D, Herrmann U, Morell A, von Muralt G, Barandun S. Transplacental passage of intravenous immunoglobulin in the last trimester of pregnancy. J Pediatr 1986;109:505-508.
Last reviewed on RxList: 8/27/2007
Additional Privigen Information
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