[PAGID] Maximum rate for IVIG

[Berger, Melvin]

Most products are labelled to start at 0.01 ml/kg/min (= 0.5 mg/kg/min for 5% and 1 mg/kg/min for 10%).  If tolerated, the rates can be increased, usually in a stepwise manner, to maximum rates of 0.08 ml/kg/min for most 10% products (= 8 mg/kg/min) and 10 ml/kg/min for 5% Flebogamma DIF (=5 mg/kg/min). Note that 8 mg/kg/min (4.8 ml/kg/hr) is 480 mg/kg/hr if it is 10%. Thus, most PID patients who are on brands they tolerate can complete their typical infusion in about 1 to 1.5 hours once they reach the maximum rate, if they tolerate that. 
 
These rates are derived from the licensing trials, which are designed to meet the FDA criterion of <40% of infusions accompanied by AEs occuring during or up to 24-48 hrs after completion of the (infusion (may differ in different studies).  Rate-related AEs are usually in the family of chills, fever, back pain, other myalgias, headache, nausea + GI Sx, etc. Renal complications are rare now that there are no longer sucrose-containing products marketed in the US. I do not think it is clear that renal AEs were rate-related. 
 
 
 
 
Mel Berger, M.D., Ph.D.
Adjunct Professor of Pediatrics and Pathology
Case Western Reserve University
phone 216 844 3237
 
Division of Allergy-Immunology
Rainbow, Babies and Children's Hospital
University Hospitals of Cleveland
RB&C Rm 504, MS 6008B
11100 Euclid Ave.
Cleveland, OH 44106

________________________________

From: pagid-bounces at list.clinimmsoc.org on behalf of Chris Seroogy
Sent: Wed 5/6/2009 5:23 PM
To: pagid at list.clinimmsoc.org
Subject: [PAGID] Maximum rate for IVIG


Dear Colleagues,

A question was recently posed to me by our pharmacy staff regarding maximum infusion rate for IVIG.  They noted some practioners maxed at 110 cc/hr of 10% solution and felt faster infusion rates may lead to renal toxicity regardless of the product formulation.  This is not something that I typically monitor and was wondering if anyone has sound data on the safety for maximum infusion rates of IVIG?  Thank you for any insights, Chris


-- 
Christine M. Seroogy MD, FAAP, FAAAAI
Assistant Professor
University of Wisconsin
Department of Pediatrics
Division of Allergy, Immunology & Rheumatology
H4/474 CSC
600 Highland Avenue
Madison, WI  53792-4108
phone: 608-263-2652
fax: 608-265-0164





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