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Synagis and Pregnancy
Because Synagis (palivizumab) is not approved for use in adults, it is unlikely that a pregnant woman would receive this drug. This medicine has not been studied in pregnant women or animals, so it is unknown whether it would cause any harm to a developing fetus. However, if your healthcare recommends using Synagis during pregnancy, discuss the benefits and risks associated with this drug.
Synagis® (palivizumab) is a prescription medication used to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants and children who have a high risk for infection. It is unknown whether this medicine is safe for use during pregnancy.
Synagis is classified as a pregnancy Category C drug. The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is used during pregnancy.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Synagis is a pregnancy Category C medicine because it has not been studied in pregnant women or animals. Therefore, very little information is available on the possible effects of Synagis on a developing fetus. However, the drug is only approved for use in infants and young children at this time. Therefore, it would normally not be used in a pregnant woman.
Synagis is not approved for use in adults. However, if your healthcare provider recommends this medicine and you are pregnant or thinking about becoming pregnant, let your healthcare provider know. He or she will consider both the benefits and risks before making a recommendation in your particular situation.
Written by/reviewed by: Susan Lakey, PharmD, MPH, BCPP
Last reviewed by: Kristi Monson, PharmD