Synagis 100 mg/mL
palivizumab · INJECTION, SOLUTION · Swedish Orphan Biovitrum AB (publ)
Synagis is a injection, solution containing palivizumab at 100 mg/mL, taken intramuscular. Manufactured by Swedish Orphan Biovitrum AB (publ).
Key Facts
- Brand Name
- Synagis
- Generic Name
- palivizumab
- NDC Code (Product)
66658-231- Manufacturer
- Swedish Orphan Biovitrum AB (publ)
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA103770
- Drug Class
- Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
- Marketing Start
- 06/19/1998
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season [see Clinical Studies ( 14 ) ]. Synagis is a respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginnin…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 15 mg per kg of body weight, administered intramuscularly prior to commencement of the RSV season and remaining doses administered monthly throughout the RSV season. ( 2.1 ) Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled. ( 2.1 , 12.3 ) 2.1 Dosing Information The recommended dose of Synagis is 15 mg per 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. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities. Synagis serum levels are decreased after cardio-pulmonary bypass [see Clinical Pharmacology ( 12.3 ) ]. Children undergoing cardio-pulmonary b…
Contraindications
4 CONTRAINDICATIONS Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis [see Warnings and Precautions ( 5.1 ) ]. Previous significant hypersensitivity reaction to Synagis. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of children in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators, or corticosteroids were similar and no incremental increase in adverse reactions was observed among children receiving these agents.
Adverse Reactions
6 ADVERSE REACTIONS The most serious adverse reactions occurring with Synagis are anaphylaxis and other acute hypersensitivity reactions [see Warnings and Precautions ( 5.1 ) ]. Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Synagis (n=1639) compared with placebo (n=1143) in children 3 days to 24.1 months of age at high risk of RSV-related hospitalization in two clinical trials. Trial 1 was conducted during a single RSV season and studied a total of 1502 children less than or equal to 24 months of age with BPD or infants with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry. Trial 2 w…
Frequently Asked Questions
What is Synagis used for?
Synagis contains palivizumab. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Synagis a controlled substance?
Synagis is not classified as a controlled substance by the DEA.
What is the generic name for Synagis?
The generic name for Synagis is palivizumab. There are no other listed brand versions of palivizumab.
What is the NDC code for Synagis 100 mg/mL?
The NDC (National Drug Code) for Synagis 100 mg/mL is 66658-231, listed by Swedish Orphan Biovitrum AB (publ).
Other Synagis Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)