No

Immune Globulin

Prevention of serious lower respiratory infection caused by respiratory syncytial virus (RSV) in children <24 months of age with bronchopulmonary dysplasia (BPD) or a history of premature birth ( less than or equal to 35 weeks gestation)

C

Selective IgA deficiency; history of severe prior reaction to any immunoglobulin preparation

Use caution to avoid fluid overload in patients, particularly infants with bronchopulmonary dysplasia (BPD), when administering RSV-IGIV; hypersensitivity including anaphylaxis or angioneurotic edema may occur; keep epinephrine 1:1000 readily available during infusion; rare occurrences of aseptic meningitis syndrome have been associated with IGIV treatment, particularly with high doses; observe carefully for signs and symptoms of such and treat promptly

1% to 10%:

Dermatologic: Rash (1%)

Cardiovascular: Tachycardia (1%), hypertension (1%), hypotension

Central nervous system: Fever (6%)

Endocrine & metabolic: Fluid overload (1%)

Gastrointestinal: Vomiting (2%), diarrhea (1%), gastroenteritis (1%)

Local: Injection site inflammation (1%)

Respiratory: Respiratory distress (2%), wheezing (2%), rales, hypoxia (1%), tachypnea (1%)

<1%: Edema, pallor, heart murmur, cyanosis, flushing, palpitations, chest tightness, dizziness, anxiety, eczema, pruritus, abdominal cramps, myalgia, arthralgia, cough, rhinorrhea, dyspnea

Likely symptoms of overdose include those associated with fluid overload

Treatment is supportive (eg, diuretics)

Decreased toxicity: Antibodies present in IVIG preparations may interfere with the immune response to live virus vaccines (eg, MMR); reimmunization is recommended if such vaccines are administered within 10 months following RSV-IVIG treatment; additionally, it is advised that booster doses of oral polio, DPT, and HIB be considered 3-4 months after the last dose of RSV-IVIG in order to ensure immunity

Store between 2°C and 8°C; do not freeze or shake vial; avoid foaming; discard after single use since it is preservative free

RSV-IGIV is a sterile liquid immunoglobulin G containing neutralizing antibody to respiratory syncytial virus. It is effective in reducing the incidence and duration of RSV hospitalization and the severity of RSV illness in high risk infants.

I.V.: 750 mg/kg/month according to the following infusion schedule:

Monitor for symptoms of allergic reaction; check vital signs, cardiopulmonary status after each rate increase and thereafter at 30-minute intervals until 30 minutes following completion of the infusion

Educate parents on the importance of reducing exposure to and transmission of RSV. Preventive measures include eliminating exposure to cigarette smoke, limiting exposure to contagious settings, and emphasizing hand washing.

Begin infusion within 6 hours and complete within 12 hours after entering vial. Observe for signs of intolerance during and after infusion; administer through an I.V. line using a constant infusion pump and through a separate I.V. line, if possible; begin infusion within 6 hours and complete within 12 hours after entering the vial; if needed, RSV-IGIV may be "piggy-backed" into dextrose with or without saline solutions, avoiding dilutions >2:1 with such line configurations. Filters are not necessary, but an in-line filter with a pore size >15 micrometers may be used.

Injection: 2500 mg RSV immunoglobulin/50 mL vial

American Academy of Pediatrics Committee on Infectious Diseases, Committee on Fetus and Newborn, "Respiratory Syncytial Virus Immune Globulin Intravenous: Indications for Use," Pediatrics, 1997, 99(4):645-50.

Ellenberg SS, Epstein JS, Fratantoni JC, et al, "A Trial of RSV Immune Globulin in Infants and Young Children: The FDA's View," N Engl J Med, 1994, 331(3):203-5.

Groothius JR, Simoes EA, Levin MJ, et al, "Prophylactic Administration of Respiratory Syncytial Virus Immune Globulin to High-Risk Infants and Young Children. The Respiratory Syncytial Virus Immune Globulin Study Group," N Engl J Med, 1993, 329(21):1524-30.

Ottolini MG and Hemming VG, "Prevention and Treatment Recommendations for Respiratory Syncytial Virus Infection. Background and Clinical Experience 40 Years After Discovery," Drugs, 1997, 54(6):867-84.

"Prevention of Respiratory Syncytial Virus Infections: Indications for the Use of Palivizumab and Update on the Use of RSV-IGIV. American Academy of Pediatrics Committee on Infectious Diseases and Committee of Fetus and Newborn," Pediatrics, 1998, 102(5):1211-6.

Simoes EA, Sondheimer HM, Top FH Jr, et al, "Respiratory Syncytial Virus Immune Globulin for Prophylaxis Against Respiratory Syncytial Virus Disease in Infants and Children With Congenital Heart Disease. The Cardiac Study Group," J Pediatr, 1998, 133(4):492-9.

Wandstrat TL, "Respiratory Syncytial Virus Immune Globulin Intravenous," Ann Pharmacother, 1997, 31(1):83-8.