Data from FDA - Curated by Toby Galbraith - Last updated 12 September 2017

Indication(s)

1 INDICATIONS AND 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)]. Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease [see Warnings and Precautions (5.4)]. 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 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. Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease. (1)

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Advisory information

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)
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 MedImmune at 1-877-633-4411 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 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. Immunogenicity In Trial 1, the incidence of anti-palivizumab antibody following the fourth injection was 1.1% in the placebo group and 0.7% in the Synagis group. In children receiving Synagis for a second season, one of the fifty-six children had transient, low titer reactivity. This reactivity was not associated with adverse events or alteration in serum concentrations. Immunogenicity was not assessed in Trial 2. A trial of high-risk preterm children less than or equal to 24 months of age was conducted to evaluate the immunogenicity of the lyophilized formulation of Synagis (used in Trials 1 and 2 above) and the liquid formulation of Synagis. Three hundred seventy-nine children contributed to the 4 to 6 months post-final dose analysis. The rate of anti-palivizumab antibodies at this time point was low in both formulation groups (anti-palivizumab antibodies were not detected in any subject in the liquid formulation group and were detected in one subject in the lyophilized group (0.5%), with an overall rate of 0.3% for both treatment groups combined). These data reflect the percentage of children whose test results were considered positive for antibodies to palivizumab in an enzyme-linked immunosorbent assay (ELISA) and are highly dependent on the sensitivity and specificity of the assay. The ELISA has substantial limitations in detecting anti-palivizumab antibodies in the presence of palivizumab. Immunogenicity samples tested with the ELISA assay likely contained palivizumab at levels that may interfere with the detection of anti-palivizumab antibodies. An electrochemical luminescence (ECL) based immunogenicity assay, with a higher tolerance for palivizumab presence compared to the ELISA, was used to evaluate the presence of anti-palivizumab antibodies in subject samples from two additional clinical trials. The rates of anti-palivizumab antibody positive results in these trials were 1.1% and 1.5%. 6.2 Postmarketing 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.

Usage information

Dosing and 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 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. The efficacy of Synagis at doses less than 15 mg per kg, or of dosing less frequently than monthly throughout the RSV season, has not been established. 2.2 Administration Instructions • DO NOT DILUTE THE PRODUCT. • DO NOT SHAKE OR VIGOROUSLY AGITATE THE VIAL. •Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration. •Using aseptic techniques, attach a sterile needle to a sterile syringe. Remove the flip top from the Synagis vial and wipe the rubber stopper with a disinfectant (e.g., 70% isopropyl alcohol). Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Administer immediately after drawing the dose into the syringe. •Synagis should be administered in a dose of 15 mg per kg intramuscularly using aseptic technique, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The dose (volume of injection in mL) per month = patient weight (kg) x 15 mg per kg ÷ 100 mg per mL of Synagis. Injection volumes over 1 mL should be given as a divided dose. •Synagis is supplied as a single-dose vial and does not contain preservatives. Do not re-enter the vial after withdrawal of drug; discard unused portion. Only administer one dose per vial. •Use sterile disposable syringes and needles. To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, DO NOT reuse syringes and needles.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Safety and effectiveness in children older than 24 months of age at the start of dosing have not been established. (8.4) 8.1 Pregnancy Risk Summary Synagis is not indicated for use in females of reproductive potential. 8.2 Lactation Risk Summary Synagis is not indicated for use in females of reproductive potential. 8.4 Pediatric Use The safety and effectiveness of Synagis in children older than 24 months of age at the start of dosing have not been established [see Clinical Studies (14) ].

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.

More information

Category Value
Authorisation number BLA103770
Agency product number DQ448MW7KS
Orphan designation No
Product NDC 60574-4114,60574-4113
Date Last Revised 12-05-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder MedImmune, LLC