Carimune® NF Nanofiltered
Immune Globulin Intravenous (Human)
Carimune
® NF is indicated for the maintenance treatment of patients with primary immunodeficiencies (PI), such as common variable immunodeficiency, X-linked agammaglobulinemia, and severe combined immunodeficiency, and for acute and chronic immune thombocytopenic purpura (ITP).
- Three complementary pathogen elimination methods to enhance the viral
safety of Carimune® NF: partitioning, virus inactivation, and
nanofiltration
- Advanced nanofiltration methodology uses a simple yet sophisticated
size-exclusion technique that removes viruses larger than the filterpores, as
well as many smaller viruses when they are complexed with antibodies, with
minimal or no effect on IgG1
- Greater dosing flexibility to adjust fluid volume and osmolality
specifically to meet patient needs
NDC Number |
Product Description |
| 44206-416-03 |
3 g immune globulin |
| 44206-417-06 |
6 g immune globulin |
| 44206-418-12 |
12 g immune globulin |
Important Safety Information
Immune Globulin Intravenous (Human) (IVIg) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.
Severe renal adverse events with Immune Globulin Intravenous (Human) have included acute renal failure, acute tubular nephrosis, proximal tubular nephropathy, and osmotic nephrosis. Monitoring of renal function and urine output is advised inpatients with a potential increased risk for developing acute renal failure. Increases in creatinine and blood urea nitrogen with progression to oliguria or anuria requiring dialysis have been observed.
As with all blood products containing IgA, Carimune® NF is contraindicated in patients with selective IgA deficiency who possess antibody to IgA. Carimune® NF may be contraindicated in patients with severe systemic reactions to IV or intramuscular administration of human immune globulin.
Carimune® NF is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
See PRECAUTIONS and DOSAGE AND ADMINISTRATION sections of full Prescribing Information for important information intended to reduce the risk of acute renal failure.
Reference: 1. CSL Behring. Data on file.
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null 31 January 2008