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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)

A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease. [2011.08]
Children with hemodynamically significant congenital heart disease (CHD) are at risk for serious respiratory syncytial virus (RSV) disease. This study was designed to assess the safety and tolerability of motavizumab versus palivizumab in children with CHD and was not powered for efficacy... Safety and efficacy were consistent with another study comparing motavizumab with palivizumab in premature infants without CHD.

Tetracaine (ametop) compared to placebo for reducing pain associated with intramuscular injection of palivizumab (synagis). [2009.12]
Infants receive many painful immunizations before they are 2 years old. The purpose of this study was to evaluate if topical tetracaine reduces the pain of intramuscular palivizumab compared to placebo...

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.

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Clinical Trials Related to Synagis (Palivizumab)

Compliance to Synagis (Palivizumab) Under Daily Pediatrician┬┤s Conditions in Premature Infants 33 - 35 wGA [Recruiting]
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against Respiratory Syncytial Virus (RSV) infection as shown in the Impact study. Many factors as parent┤s knowledge of burden of RSV disease or physicians satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians

practice conditions in premature infants 33 - 35 wGA.

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]

Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions [Recruiting]
The purpose of this study is to evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America [Recruiting]

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Reports of Suspected Synagis (Palivizumab) Side Effects

Pyrexia (206)Dyspnoea (173)Cough (162)Bronchiolitis (112)Nasopharyngitis (109)Pneumonia (91)Vomiting (81)Death (78)Viral Infection (65)Hypophagia (62)more >>


Page last updated: 2011-12-09

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