Synagis®: RSV protection medication for high-risk babies' lungs

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Synagis&reg is the only FDA-approved medication to help protect high-risk babies' lungs from severe RSV.

Respiratory syncytial virus (RSV) is the #1 cause of hospitalization in babies under a year. So make sure you get the facts about Synagis, a monthly injection designed to help protect preemies and other high-risk babies during RSV season. Understand why Synagis shots are given every 28-30 days. And know how to be prepared, no matter when RSV season starts in your area.

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.

Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Other 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. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. Side effects, such as, skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) can also occur.