Synagis (Palivizumab) - Summary

SYNAGIS SUMMARY

Synagis® (palivizumab) is a humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV).

Synagis® is indicated for the 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), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).

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NEWS HIGHLIGHTS

Published Studies Related to Synagis (Palivizumab)

Palivizumab prophylaxis, respiratory syncytial virus, and subsequent recurrent wheezing. [2007.07]
OBJECTIVE: Children who experience respiratory syncytial virus (RSV) lower respiratory tract infections (LRTIs) early in life have high rates of subsequent recurrent wheezing. Palivizumab, an anti-RSV monoclonal antibody, has 78% to 80% efficacy in preventing RSV hospitalization in premature infants without chronic lung disease. We hypothesized that palivizumab, by ameliorating or preventing early RSV LRTI in preterm infants, might decrease later recurrent wheezing... CONCLUSIONS: Our study suggests that preventing RSV LRTI with palivizumab may reduce subsequent recurrent wheezing in premature infants.

Palivizumab prophylaxis to prevent respiratory syncytial virus mortality after pediatric bone marrow transplantation: a decision analysis model. [2007.04]
OBJECTIVE: Palivizumab, a monoclonal antibody against respiratory syncytial virus (RSV), has been demonstrated to be safe and effective in young children, but evidence is lacking as to whether palivizumab is effective in preventing RSV-induced morbidity and mortality in children who are immunosuppressed after bone marrow transplantation (BMT). As a randomized, double-blind, placebo-controlled trial is lacking, we chose to examine this issue with the use of decision analysis methodology... CONCLUSIONS: Decision analysis modeling demonstrates a decrease in mortality in pediatric BMT patients with the addition of palivizumab to protect against RSV-related lung disease. A well-designed, randomized controlled trial is necessary.

Safety and immunogenicity of palivizumab (Synagis) administered for two seasons. [2005.11]
To evaluate the safety and immunogenicity of palivizumab, 55 children who received palivizumab in the IMpact-RSV trial received 5 monthly doses of 15 mg/kg palivizumab (Synagis) during the subsequent year. The single child with an antipalivizumab titer of >1/40 had no associated serious adverse events and had expected serum palivizumab trough concentrations.

Safety and pharmacokinetics of palivizumab therapy in children hospitalized with respiratory syncytial virus infection. [2004.08]
BACKGROUND: Respiratory syncytial virus (RSV) infection represents a major cause of pediatric respiratory hospitalizations. Limited treatment options exist. Palivizumab is a humanized monoclonal IgG1 antibody to the fusion protein of RSV that is highly active against RSV A and B strains... CONCLUSIONS: Intravenous palivizumab was safe and well-tolerated in children hospitalized with RSV disease. A single 15-mg/kg dose achieved serum palivizumab concentrations above the 25- to 30-microg/mL concentration associated with 2-log reduction of pulmonary RSV titer in the cotton rat model.

Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. [2003.10]
OBJECTIVES: To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD)... CONCLUSIONS: Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.

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Clinical Trials Related to Synagis (Palivizumab)

A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis) [Completed]
A total of 150 children who meet the entry criteria will be randomized 1: 1 to receive one of the following treatment sequence A or B.

Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of MEDI-493, Synagis [Active, not recruiting]

Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study [Completed]
This is a small study known as a pilot study. This pilot study is being done to see if a difference in pain from intramuscular palivizumab injection can be detected if tetracaine a topical numbing gel is used compared to no medication (placebo). If a difference is found in this pilot study, then a larger study may be done to confirm that there is a difference in pain experience.

Study of Motavizumab (MEDI-524) and Palivizumab in the Same Respiratory Syncytial Virus (RSV) Season [Completed]
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab will be administered to high-risk children during the same respiratory syncytial virus (RSV) season. It is anticipated that approximately 240 children (80 in each group) will be enrolled from the southern hemisphere during the upcoming RSV season (2006).

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524 After Dosing for a Second Season in Children [Completed]

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