Brand Name
Synagis
Generic Name
Palivizumab
View Brand Information FDA approval date: June 19, 1998
Classification: Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Form: Injection
What is Synagis (Palivizumab)?
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients: with a history of premature birth and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia 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 and who are 24 months of age or younger at the beginning of RSV season. Synagis is a respiratory syncytial virus F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients: with a history of premature birth and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia 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 and who are 24 months of age or younger at the beginning of RSV season. Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease. Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease [see Warnings and Precautions.
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Brand Information
Synagis (palivizumab)
1INDICATIONS 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
2DOSAGE FORMS AND STRENGTHS
Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL.
3CONTRAINDICATIONS
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis
4ADVERSE REACTIONS
The most serious adverse reactions occurring with Synagis are anaphylaxis and other acute hypersensitivity reactions
4.1Clinical 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 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease.
In Trials 1 and 2 combined, fever and rash were each reported more frequently among Synagis than placebo recipients, 27% versus 25%, and 12% versus 10%, respectively. Adverse reactions observed in the 153-patient crossover study comparing the liquid and lyophilized formulations were comparable for the two formulations, and were similar to those observed with Synagis in Trials 1 and 2.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of Synagis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: severe thrombocytopenia (platelet count less than 50,000 per microliter)
General Disorders and Administration Site Conditions: injection site reactions
Limited information from post-marketing reports suggests that, within a single RSV season, adverse events after a sixth or greater dose of Synagis are similar in character and frequency to those after the initial five doses.
5DRUG 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.
6OVERDOSAGE
Overdoses with doses up to 85 mg per kg have been reported in clinical studies and post-marketing experience with Synagis, and in some cases, adverse reactions were reported. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
7DESCRIPTION
Palivizumab is a humanized monoclonal antibody (IgG1κ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of RSV. Palivizumab is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the V
Synagis is supplied as a sterile, preservative-free liquid solution at 100 mg per mL to be administered by intramuscular injection. Thimerosal or other mercury-containing salts are not used in the production of Synagis. The solution has a pH of 6.0 and should appear clear or slightly opalescent.
Each 100 mg single-dose vial of Synagis liquid solution contains 100 mg of palivizumab and also contains chloride (0.5 mg), glycine (0.1 mg), and histidine (3.9 mg), in a volume of 1 mL.
Each 50 mg single-dose vial of Synagis liquid solution contains 50 mg of palivizumab and also contains chloride (0.2 mg), glycine (0.06 mg), and histidine (1.9 mg), in a volume of 0.5 mL.
8CLINICAL STUDIES
The safety and efficacy of Synagis were assessed in two randomized, double-blind, placebo-controlled trials of prophylaxis against RSV infection in children at high risk of an RSV-related hospitalization. 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 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease. In both trials participants received 15 mg per kg Synagis or an equivalent volume of placebo via intramuscular injection monthly for five injections and were followed for 150 days from randomization. In Trial 1, 99% of all subjects completed the study and 93% completed all five injections. In Trial 2, 96% of all subjects completed the study and 92% completed all five injections. The incidence of RSV hospitalization is shown in
In Trial 1, the reduction of RSV hospitalization was observed both in children with BPD (34/266 [12.8%] placebo versus 39/496 [7.9%] Synagis) and in premature infants without BPD (19/234 [8.1%] placebo versus 9/506 [1.8%] Synagis). In Trial 2, reductions were observed in acyanotic (36/305 [11.8%] placebo versus 15/300 [5.0%] Synagis) and cyanotic children (27/343 [7.9%] placebo versus 19/339 [5.6%] Synagis).
The clinical studies do not suggest that RSV infection was less severe among children hospitalized with RSV infection who received Synagis for RSV prophylaxis compared to those who received placebo.
9HOW SUPPLIED/STORAGE AND HANDLING
Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.
50 mg vial NDC 66658-230-01
The 50 mg vial contains 50 mg Synagis in 0.5 mL.
100 mg vial NDC 66658-231-01
The 100 mg vial contains 100 mg Synagis in 1 mL.
The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.
10PATIENT COUNSELING INFORMATION
Advise the patient's caregiver to read the FDA-approved patient labeling (
11Principal Display Panel - 50 mg/0.5 mL Carton Label
NDC 66658-230-01
SYNAGIS
PALIVIZUMAB
50 mg/0.5 mL
For Intramuscular Injection Only
Store at 2 to 8°C (36 to 46°F).
Single-dose vial.
Discard unused portion.
12Principal Display Panel - 50 mg/0.5 mL Vial Label
NDC 66658-230-01
50 mg/0.5 mL
SYNAGIS
PALIVIZUMAB
For Intramuscular
Injection Only
Injection Only
US Lic. 1859
13Principal Display Panel - 100 mg/mL Carton Label
NDC 66658-231-01
SYNAGIS
PALIVIZUMAB
100 mg/mL
For Intramuscular Injection Only
Store at 2 to 8°C (36 to 46°F).
Single-dose vial.
Discard unused portion.
14Principal Display Panel - 100 mg/mL Vial Label
NDC 66658-231-01
100 mg/mL
SYNAGIS
PALIVIZUMAB
For Intramuscular
Injection Only
Injection Only
US Lic. 1859
