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Heart Function Service: Heart Transplant Protocols

               Protocol for Administration of Intravenous Immunoglobulin (IVIG)



               Purpose:  To provide procedures for administrating and for monitoring patients receiving Intravenous
               Immunoglobulin (IVIG)

               Policy:

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                   A.  Those who administer IVIG and monitor patients receiving IVIG at Children’s Health  will follow
                       the established Protocols included in this document
                   B.  The procedure will be revised and approved by the Pharmacy & Therapeutics Committee at
                       Children’s Health as needed according to notifications recommended by the
                       manufacturer/evidence in the clinical literature.
                   C.  IVIG therapy may provide benefit for a variety of disease states. The dose can vary from 0.1-2
                       gram/kg per dose depending on indication. (See Attachment A “IVIG Indications and Suggested
                       Dosing”) Some disease states may benefit from repeat doses and individualization of dose and
                       regimen. During times of limited IVIG supply, use is to be reserved for those indications with
                       Food and Drug Administration (FDA) approval and off-label indications that have demonstrated
                       benefit, provided the risks of administration have been carefully considered.

                   BLACK BOX WARNING: IVIG 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 greater than 65,
                   volume depletion, sepsis, paraproteinemia, or patient’s receiving known nephrotoxic drugs.
                   Especially in such patients, IVIG 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 IVIG products, those
                   containing sucrose as a stabilizer accounted for a disproportionate share of the total number.
                   Gamunex and Gammagard do not contain sucrose.

                   D.  Patients are to be monitored closely especially during the infusion, as the administration of IVIG
                       can be associated with many adverse effects including:
                         Flu-like symptoms
                         Rash
                         Blood pressure instability
                         Volume overload
                         Anaphylaxis
                         Bronchospasm
                         Thromboembolic events
                         Acute renal failure
                         Aseptic meningitis
                   E.  Reactions with subsequent infusions may be prevented/reduced by pretreatment with
                       acetaminophen, diphenhydramine, and/or corticosteroids.

               Responsibility
               Medical Staff, Pharmacy, Nursing and other clinical employees.

               Other Applicable Policies
               None






               Updated November 9, 2017                                                                    69
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