Synagis® (palivizumab) is the only monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) to help prevent an infectious disease. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. The safety and efficacy of Synagis were established in infants with bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).
RSV is the most common respiratory infection in infancy or childhood that circulates in the Northern Hemisphere predominately in the winter months. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease or with CHD are at high risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients).
www.synagis.com Provides more in-depth, technical information abut RSV for an audience of consumers and healthcare professionals. It also outlines RSV epidemiology, as well as provides patient assistance and insurance information.
Important Safety Information
Synagis ® (palivizumab) is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children at high risk. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season.
Synagis should not be used in patients with a history of a severe allergic reaction to Synagis or its ingredients. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions may occur when any dose of Synagis is given, not just the first one. Very low platelet counts may occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.
Common side effects may include fever, cold-like symptoms (upper respiratory infection) including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain types of heart disease, other possible side effects include bluish color of the skin, lips or under fingernails and abnormal heart rhythms. These are not all the possible side effects of Synagis.
Please see accompanying full prescribing information, including patient information.
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