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 gestation).
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 stays.
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 RespiGam.
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.