Synagis

Respiratory Syncytial Virus Monoclonal Antibody

 

Q: What is Respiratory Syncytial Virus (RSV) and how does it affect humans?

Respiratory syncytial virus is the most common respiratory pathogen in infants and young children. It infects virtually all infants by the age of two years. In most infants, the virus causes symptoms resembling those of the common cold. In infants born prematurely and/or with bronchopulmonary dysplasia or heart disease, RSV can cause a severe or even life- threatening disease. Each year RSV disease results in over 90,000 hospitalizations and about 2% of these patients die.

 

Q: How easily is RSV transmitted?

RSV is highly contagious. Each year, up to 50% of susceptible infants are infected. RSV can spread very rapidly in the hospital environment; up to 40% of hospitalized children may become infected. Transmission occurs by contact with infectious secretions via hand contamination and self-inoculation of eyes, nose, or mouth; or by contact with large-droplet aerosols or formites. RSV can survive for 4-7 hours on countertops. Transmission may be prevented by standard infection control practices, such as hand washing.

 

Q: How often do outbreaks occur? 

RSV outbreaks occur on a yearly basis. In S. Florida, RSV is present year round, but the incidence is higher from July to April.

RSV infection does not protect against subsequent infections. When school age children and adults get RSV, they may have symptoms of a common cold. If they bring this virus to the home of a newborn, the newborn may get very ill.

 

Q: How is RSV infection treated?  

Treatment of severe RSV infection is mostly supportive, to ensure adequate oxygenation, hydration, and nutrition. ICU admission may be needed antiviral agent, Ribavirin, a registered trademark of ICN, may be useful, in few cases.

 

Q: Is there an RSV vaccine available?

At this date, there are no safe and effective RSV vaccines. There are two effective preventive agents available. Respigam (respiratory syncytial virus immune globulin intravenous), a polyclonal antibody, provides effective prevention against RSV, and Synagis (palivizumab), a monoclonal antibody, which provides protection against serious lower respiratory tract infections caused by RSV in infants and children at high risk for RSV disease. Synagis is more potent than Respigam, and is administered by simple, monthly IM injections.

 

Q: What is Synagis (Palivizumab)? 

Synagis is a monoclonal antibody produced by recombinant biotechnology, which is specifically designed to neutralize respiratory synical virus (RSV). Monthly intramuscular (IM) injections of Synagis prior to and during the RSV season have been shown to significantly reduce  RSV hospitalizations in infants at high risk.

 

Q: What side effects are associated with Synagis?

In the IM pact- RSV trial, there were no statistically significant differences in adverse events between the Synagis group and the placebo group. Adverse events that occurred in more than 1% of patients in the Synagis group for which the the incidence was >

1% higher than in the placebo group included upper respiratory infection, otitis media, rhinitis, rash, pain, hernia, SGOT increased, and pharyngitis. Synagis was discontinued in only five of 1,002 patients; two because of vomiting and diarrhea, one because of moderate injection- site reaction, and two for pre-existing conditions.

 

Q: Does Synagis have any drug interactions?

No formal drug-drug interaction studies were conducted. In the IMpact- RSV trial, Synagis was associated with any increase in adverse reactions among children who received routine childhood vaccines, influenza vaccine, bronchodilators, or steroids.

 

Q: Who should receive Synagis? 

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV. Candidates for prophyaxis with Synagis include premature infants (32 weeks gestation) without bronchopulmory dysplasia (BPD). Other candidates include infants with BPD requiring medical management in the prior six months. Other infants (35 weeks gestation) at risk for RSV may be considered on a case-by-case basis, especially if any of the following risk factors are present multiple birth, crowded household (> 4 people, or siblings) child will be going to day care, if smokers are present in the household, especially the mother. Some infants may benefit from prophylaxis for two RSV seasons.    

 

Q: Can Synagis be given with routine childhood vaccines or other immune globulins?

Synagis is not expected to interfere with routine childhood vaccines or other immune globulins. However, no formal drug-drug interaction studies have been conducted. 

 

                In S. Florida, since the RSV season is long, your doctor will help decide how long your baby will need to get Synagis.

                Please remember that all children get infected with RSV. Synagis is used for a few months to prevent severe disease caused by this virus. As your child grows, the lungs grow as well. Therefore, as the child grows, the severity of disease caused by RSV should be less.