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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.

RESPIGAM
(Respiratory Syncytial Virus Immune Globulin Intravenous (Human))
(RSV-IGIV)

Indication

  • Respigam is indicated for the prevention of serious lower respiratory tract infection caused by RSV in
    1. infants under 24 months of age with bronchopulmonary dysplasia (BPD) and who have required oxygen within the 6 months preceding the RSV season
    2. infants born < 32 weeks gestation and aged < 6 months as of the start of the RSV season

Clinical Pharmacology

  • Respigam contains a high concentration of neutralizing antibodies directed against both subgroups A and B of respiratory syncytial virus (RSV)
  • the mean half-life of serum RSV neutralizing antibodies after Respigam infusion is 22 - 28 days
  • in the PREVENT trial, a randomized, placebo-controlled, double blind study of the safety and efficacy of Respigam in the prophylaxis of RSV disease in infants with BPD (and less than 24 months old at study entry) or prematurity (< 35 weeks gestation; < 6 months of age at study entry), Respigam reduced the incidence of RSV hospitalization from 13.5% to 8.0% (53% relative risk reduction)

Side Effects

  • Respigam is generally well tolerated
  • adverse effects that have been reported in clinical trials (1% incidence) in both the placebo group and Respigam (C) group include fever / pyrexia, respiratory distress, vomiting, wheezing, fluid overload, tachycardia, rash, hypertension, hypoxia, tachypnea, and injection site inflammation
  • less frequent (<1% incidence) adverse reactions potentially related to Respigam include edema, pallor, hypotension, heart murmur, gagging, cyanosis, cough, cold and clammy skin
  • reactions similar to those with other IVIGs may occur with Respigam ; these include flushing, palpitations, blood pressure changes, palpitations, chest tightness, dyspnea; these reactions may have been related to the rate of the infusion.

WARNINGS

  • immediate allergic, anaphylactic or hypersensitivity reactions may be observed. Epinephrine (1 : 1,000) should be available in the event that a hypersensitivity reaction occurs.
  • rarely, aseptic meningitis syndrome has been reported in association with IVIG treatment, particularly at high dosage (2,000 mg/kg)
  • infants with underlying pulmonary disease may be sensitive to extra fluid volume; in the PREVENT trial 8.4% of infants (1% premature and 13% BPD) received new or extra diuretics during the period 24 hours before through 48 hours after at least one of their infusions of Respigam (C). Infants with clinically apparent fluid overload should not be infused with Respigam(C). A loop diuretic (eg furosemide) should be available for management of fluid overload.

Dose and Administration

Dose = 750 mg/kg monthly (total of 5 doses), by infusion

Infusion Schedule
Time after start of infusionRate of Infusion
(mL/kg of Body Mass per hour)
0 - 15 minutes1.5 mL/kg/h
15 - 30 minutes3 mL/kg/h
30 minutes to end of infusion6 mL/kg/h (MAXIMUM rate)
  • do NOT SHAKE vial; avoid foaming
  • the patient's vital signs and cardiopulmonary status should be assessed prior to infusion, before each rate increase and thereafter at 30 minute intervals until 30 minutes following completion of the infusion.
  • Respigam should be administered through an IV line using a constant infusion pump
  • predilution of Respigam is NOT recommended; however, it may be "piggy-backed" into a pre-existing line (compatible with both dextrose and/or sodium chloride solutions)
  • the infusion should begin within 6 hours and should be completed within 12 hours after the single-use vial is entered

Supplied

  • 50 mL vial of 50 mg/mL liquid immunoglobulin
  • store in refrigerator
  • single use only

References

  1. Respigam(R) Product Monograph, MedImmune, Inc, Gaithersburg, MD, January, 1996.

This monograph was updated on Dec 4, 1998.


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