Home' The Source : Second Quarter 2013 Contents Please see Highlights of Prescribing Information on adjacent page.
octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. octagam 5% liquid contains trace amounts of
IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. octagam 5% liquid
is contraindicated in patients with acute hypersensitivity reaction to corn. octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients
known to have corn allergies should avoid using octagam 5% liquid.
WARNINGS AND PRECAUTIONS AND PRECAUTIONS
IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Epinephrine should be available
immediately to treat any acute severe hypersensitivity reactions. Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at
risk of developing acute renal failure. Falsely elevated blood glucose readings may occur during and after the infusion of octagam 5% liquid with some glucometer and test
strip systems. Hyperproteinemia, increased serum viscosity and hyponatremia occur in patients receiving IGIV therapy. Thrombotic events have occurred in patients receiving
IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. Aseptic
Meningitis Syndrome has been reported with octagam 5% liquid and other IGIV treatments, especially with high doses or rapid infusion. Hemolytic anemia can develop
subsequent to IGIV therapy due to enhanced RBC sequestration. IGIV recipients should be monitored for pulmonary adverse reactions (TRALI). The product is made from
human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
Proven clinical efficacy
in patients with
thromboembolic safety 3
1. Octagam , Immune Globulin Intravenous (Human) 5% Liquid Preparation, complete Prescribing Information. 2009.
2. Ochs HD, Pinciaro PJ. Octagam 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J
Clin Immunol 2004;24:309-14.
3. Roemisch J, et al. Identification of activated FXI as the major biochemical root cause in IVIG batches associated with thromboembolic events. analytical
and experimental approaches resulting in corrective and preventive measures implemented into the Octagam manufacturing process. WebmedCentral
To report suspected adverse reactions,
contact Octapharma USA, Inc.
FDA at 1-800-FDA-1088 or
For more information, please contact us:
Octapharma USA, Inc.
121 River Street
Hoboken, NJ 07030
WARNING: ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic
nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus,
age >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. octagam® (Human) 5% liquid does not contain sucrose. (See Dosage and Administration and WARNINGS and
PRECAUTIONS in enclosed Full Prescribing Information for important information intended to reduce the risk of acute renal failure.)
© 2012, Octapharma USA, Inc. All rights reserved.
Date of Preparation 6/12. GAM5-003-PAD-R1
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