No

Monoclonal Antibody

Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease; safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD) and infants with a history of prematurity ( less than or equal to 35 weeks gestational age)

C

Animal reproduction studies have not been conducted; it is not known whether palivizumab can cause fetal harm when administered to a pregnant woman or could affect reproductive capacity

Patients with a history of severe prior reaction to palivizumab or other components of the product

Anaphylactoid reactions have not been observed following palivizumab administration; however, can occur after administration of proteins. Safety and efficacy of palivizumab have not been demonstrated in the treatment of established RSV disease.

The incidence of adverse events was similar between the palivizumab and placebo groups

Central nervous system: Nervousness

Dermatologic: Fungal dermatitis, eczema, seborrhea

Gastrointestinal: Diarrhea, vomiting, gastroenteritis

Hematologic: Anemia

Hepatic: ALT increase, abnormal LFTs

Local: Injection site reaction

Ocular: Conjunctivitis

Respiratory: Cough, wheezing, bronchiolitis, pneumonia, bronchitis, asthma, croup, dyspnea, sinusitis, apnea

Miscellaneous: Oral moniliasis, failure to thrive, viral infection, flu syndrome

No data from clinical studies are available

No formal drug interaction studies have been conducted

Store in refrigerator at a temperature between 2°C to 8°C (35.6°F to 46.4°F) in original container; do not freeze

Exhibits neutralizing and fusion-inhibitory activity against RSV; these activities inhibit RSV replication in laboratory and clinical studies

Half-life: ~18 days

Children: I.M.: 15 mg/kg of body weight, monthly throughout RSV season (First dose administered prior to commencement of RSV season)

Injection should (preferably) be in the anterolateral aspect of the thigh; gluteal muscle should not be used routinely; injection volume over 1 mL should be given as divided doses

May rarely cause nervousness

May cause anemia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Injection, lyophilized: 100 mg

Johnson S, Oliver C, Prince GA, et al, "Development of a Humanized Monoclonal Antibody (MEDI-493) With Potent In Vitro and In Vivo Activity Against Respiratory Syncytial Virus," J Infect Dis, 1997, 176(5):1215-24.

"Palivizumab, a Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization From Respiratory Syncytial Virus Infection in High-Risk Infants. The IMpact-RSV Study Group, ," Pediatrics, 1998, 102(3 Pt 1):531-7.

"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 on 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.

Subramanian KN, Weisman, LE, Rhodes T, et al, "Safety, Tolerance and Pharmacokinetics of a Humanized Monoclonal Antibody to Respiratory Syncytial Virus in Premature Infants With Bronchopulmonary Dysplasia. MEDI-493 Study Group," Pediatr Infect Dis J, 1998, 17(2):110-5.

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

Welliver RC, "Respiratory Syncytial Virus Immunoglobulin and Monoclonal Antibodies in the Prevention and Treatment of Respiratory Syncytial Virus Infection," Semin Perinatol, 1998, 22(1):87-95.