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Disclaimer to the On-line Edition
This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

Intravenous Immune Globulin (IVIG)

Brand Names:

GamimuneN, 10% **, Gammagard, Polygam, Sandoglobulin, Venoglobulin, Panglobulin, Iveegam

** Gamimune N, 10% is the specific brand in use at St Joseph's Hospital, as of December 2003.**

Indication

(The indications for use of IVIG in neonates include, but are not limited to, the following, which have been the most common indications in our experience. We have also rounded doses to 500 mg and provided specific guidelines for the Rate of Infusion.)

  1. Adjuvant therapy for fulminant neonatal sepsis (i.e., in addition to standard therapy)(2)
  2. Idiopathic thromocytopenic purpura (ITP)(1)
  3. Neonatal alloimmune thrombocytopenia (prophylaxis and treatment)(6)
  4. Hyperbilirubinemia related to (immune) hemolytic disease(4)

Pharmacology(1,4,5)

  • IVIG is a sterile solution of human protein that is derived by the fractionation of large pools of human plasma
  • Over 98% of the protein is IgG; there are traces of IgA and IgM also present (Gamimune N,10%)
  • IVIG provides passive immunity by increasing antibody titer and the antigen-antibody reaction potential
  • May enhance neonatal host defence by providing opsonic (i.e., attaches to pathogens) antibody, thereby enhancing phagocytosis and destruction of bacteria by neutrophils
  • IVIG may also neutralize toxins, immunomodulate T-cells and macrophages as well as affect B cell function and the complement system
  • It is believed that IVIG occupies the Fc receptor of cells of the reticuloendothelial system, thereby preventing hemolysis in hemolytic disease of the newborn and destruction of platelets in neonatal alloimmune thrombocytopnia

Side Effects(1)

  • Cardiovascular: hypotension, tachycardia, pallor, flushing of face
  • CNS: fever, chills, irritability
  • Dermatologic: urticaria, purpura
  • Gastrointestinal: vomiting
  • Hematologic: transient neutropenia, hemolytic anemia
  • Renal: acute renal failure
  • Miscellaneous: diaphoresis, hypersensitivity reactions

Monitoring

  • Frequent heart rate and blood pressure readings
  • Platelets
  • Renal function

Contraindications(1,5)

  • Hypersensitivity or severe systemic response to immune globulin or blood products
  • Patients with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) - these patients may experience severe reactions to the IgA which may be present

Precautions(1)

  • use with caution in patients at risk of developing acute renal failure (including patients who are receiving concomitant nephrotoxic drugs).
  • Administer at recommended rate (see "Rate of Infusion"); rapid infusion may be a risk factor for vascular occlusive events that have been associated with IVIG
  • Assure that patients are not volume depleted prior to administration of an IVIG infusion

Administration(1,2)

  • Do NOT administer IM or SC
  • Epinephrine should be readily available
  • Stability: do not mix with other drugs or iv infusion fluids

Indications and Dose

(The indications for use of IVIG in neonates include, but are not limited to, the following, which have been the most common indications in our experience.)

  • Adjuvant therapy for fulminant neonatal sepsis (i.e., in addition to standard antibiotic therapy)(2)

    500 mg/kg, as a single daily dose, for 2 days

  • Idiopathic thromocytopenic purpura (ITP)(1,2)

    500 -1000 mg/kg, as a single daily dose, for 2-5 consecutive days; maintenance dose : 500 - 1000 mg/kg/dose every 3 - 6 weeks based on clinical response and platelet count

  • Neonatal alloimmune thrombocytopenia (prophylaxis and treatment)

    500 mg/kg(6)

  • Hyperbilirubinemia related to (immune) hemolytic disease(4)

    500 mg/kg as soon as possible after admission to the NICU

Rate of infusion**(5)

  • Administer by slow IV infusion over 2-4 hours
  • Start the infusion at 1 mL/kg/hr of body weight for the first 30 minutes.
  • If well tolerated, may gradually increase to a maximum of 3.5 mL/kg/h

** These directions are specifically for Gamimune N,10%. For this specific product 500 mg is equivalent to 5 mL. For all other brands please consult the specific product monograph.**

References

  1. Taketomo CK Hodding JH, Kraus DM: Pediatric Dosage Handbook, 9th EDT

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