Resources for HCPs and their Patients. This site is intended for US health care professionals only.
Synagis is an FDA-approved prescription injection of antibodies that is given monthly to help protect high-risk infants from severe RSV disease throughout the RSV season. It contains virus-fighting antibodies that can help protect high-risk infants from severe RSV disease, via an injectable dose every 28–30 days throughout the RSV season. A child may still get severe RSV disease after receiving Synagis. If your patient has an RSV infection, they should continue to get their monthly shots throughout the RSV season to help prevent severe disease from new RSV infections.
Indication and Select Safety Information.
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis.
These tools provide access to a broad spectrum of resources about Respiratory Syncytial Virus (RSV) and Synagis for you and your clinical team members
Learn more about RSVID, which helps assess pediatric patients for risk of severe RSV disease. Click here to access the RSVID tool and to download the RSVID Log and start using it to streamline your office’s referral process.
Utilize this dosing guide to ensure you are prescribing the correct dose of Synagis to your high-risk patients. Click here to access the dosing guide.
Click here to navigate an essential coordinator resource that provides best practices, tips, and resources to help manage the Synagis referral process, patient support, and financial assistance. Coordinators can utilize resources and have the opportunity to become certified.
The following resources can help patients and families access information about RSV and Synagis to determine if their child is at high-risk
Access 360™ is a comprehensive referral and reimbursement program that can help address financial and coverage barriers to Synagis if it has been prescribed for your high-risk patient. Click here to learn more.
Click here to download this educational brochure to help parents learn about how Synagis may help protect their high-risk baby from severe RSV disease.
Click here to access and discuss with your patients for whom you prescribe Synagis
Click here to download the Cradle with Care HCP brochure, which you can share with patients' families to provide them with education and appointment reminders designed to encourage and facilitate compliance with RSV prophylaxis.
Important Safety Information
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). The recommended dose of Synagis is 15 mg/kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.
The efficacy of Synagis at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to Synagis. The relationship between these reactions and the development of antibodies to Synagis is unknown. If a significant hypersensitivity reaction occurs with Synagis, its use should be permanently discontinued. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder. Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.
Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) and injection site reactions have been reported.