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WARNINGS
Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death (30,31,32,33,34,35). 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
- patients receiving known nephrotoxic drugs
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.
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Immune Globulin Intravenous (Human), Carimune™ NF, 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 through the application of viral elimination/reduction steps such as alcohol fractionation in the presence of filter aids, nanofiltration and pH4/pepsin treatment (4,5,6; see Table 1). Despite these measures, such products may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 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 ZLB Bioplasma Inc., Tel. no: 866 244 29 52. The physician should discuss the risks and benefits of this product with the patient.
Patients with agamma- or extreme hypogammaglobulinemia who have never before received immunoglobulin substitution treatment or whose time from last treatment is greater than 8 weeks, may be at risk of developing inflammatory reactions on rapid infusion (greater than 1 mL per minute) of Immune Globulin Intravenous (Human), Carimune™ NF. These reactions are manifested by a rise in temperature, chills, nausea, and vomiting. The patient's vital signs should be monitored continuously. The patient should be carefully observed throughout the infusion, since these reactions on rare occasions may lead to shock. Epinephrine should be available for treatment of an acute anaphylactic reaction.
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PRECAUTIONS
Please see DOSAGE AND ADMINISTRATION below, for important information on Immune Globulin Intravenous (Human), Carimune™ NF, compatibility with other medications or fluids. Patients should not be 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) and serum creatinine, should be assessed prior to the initial infusion of Carimune™ NF 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 Carimune™ NF at a rate less than 2 mg/kg/min.
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 physicians.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Immune Globulin Intravenous (Human), Carimune™ NF. It is also not known whether Carimune™ NF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Carimune™ NF should be given to a pregnant woman only if clearly needed (23). Intact immune globulins such as those contained in Carimune™ NF cross the placenta from maternal circulation increasingly after 30 weeks gestation (36,37). In cases of maternal ITP where Carimune™ NF was administered to the mother prior to delivery, the platelet response and clinical effect were similar in the mother and neonate (23,37-46).
PEDIATRIC USE
High dose administration of Immune Globulin Intravenous (Human), Carimune™, in pediatric patients with acute or chronic Immune Thrombocytopenic Purpura did not reveal any pediatric-specific hazard (14). Antibodies in Immune Globulin Intravenous (Human) may impair the efficacy of live attenuated viral vaccines such as measles, rubella, and mumps (47,48,49). Immunizing physicians should be informed of recent therapy with Immune Globulin Intravenous (Human) so that appropriate precautions may be taken.
ASEPTIC MENINGITIS SYNDROME
An aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with Immune Globulin Intravenous (Human) (IGIV) treatment. 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. 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. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
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Page last updated: 2006-07-07
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