Important Safety Information
Synagis® (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. The first dose of Synagis should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been used in more than one million children in the U.S. since its introduction in 1998.
Synagis should not be used in patients with a history of severe prior reaction to Synagis or its components. 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. Another serious side effect, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin, has been reported.
Most common side effects with Synagis may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) have also been reported.
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