Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Immunology | Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Family Medicine | Infections and Infectious Diseases
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RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved January 1996
Treatment Area: RSV, bronchopulmonary dysplasia
RespiGam has been approved for the prevention of respiratory
syncytial virus (RSV) disease in children under 24 months with a
chronic lung disease called bronchopulmonary dysplasia or a history
of premature birth.
RespiGam is made from plasma taken from large numbers of normal,
healthy individuals and contains a high concentration of protective
antibodies against RSV. These antibodies do not prevent RSV
infections but help protect children against the most serious
consequences of RSV. RespiGam is given intravenously in five
monthly doses, with the first dose given in November before the
start of the RSV season. RSV outbreaks occur in the United States
during the late fall, winter, and early spring.
Data supporting the licensing of RespiGam was obtained in
several clinical trials including one known as the Prevent trial.
This randomized, placebo-controlled double-blind study included 510
subjects with BPD less than two years old or children under six
months old with a history of premature birth (less than 35 weeks
RespiGam reduced the number of hospitalizations by 41% and time
in the hospital by 53% in the Prevent trial. In addition, children
required fewer days of supplemental oxygen during their hospital
As with any human immune globulin product rare allergic
reactions to RespiGam are possible. In addition, infants with
pulmonary disease may retain fluids and a small percentage of
infants in the trials needed new or extra diuretics after receiving
In the United States, more than 90,000 children are hospitalized
and 4,500 die each year from the disease.
Because RespiGam is made from human plasma, a small risk exists
for the transmission of blood-borne viruses. However, the risk is
low because plasma donors are screened carefully and the product is
treated with a solvent-detergent viral inactivation procedure which
inactivates most significant blood-borne viruses, including the one
that causes AIDS.