Synagis® is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD) (see CLINICAL STUDIES).

The recommended dose of Synagis® is 15 mg/kg of body weight. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the RSV season. The first dose should be administered prior to commencement of 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). Patients undergoing cardio-pulmonary bypass should receive a 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.

Synagis® should be administered in a dose of 15 mg/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 per month = patient weight (kg) x 15 mg/kg ÷ 100 mg/mL of Synagis® . Injection volumes over 1 mL should be given as a divided dose.

Preparation of Lyophilized Product for Administration

• To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent.
• Both the 50 mg and 100 mg vials contain an overfill to allow the withdrawal of 50 mg or 100 mg Synagis® respectively when reconstituted following the directions described below.
• SLOWLY add 0.6 mL of sterile water for injection to the 50 mg vial or add 1.0 mL of sterile water for injection to the 100 mg vial. The vial should be tilted slightly and gently rotated for 30 seconds to avoid foaming. DO NOT SHAKE or VIGOROUSLY AGITATE the vial. This is a critical step to avoid prolonged foaming.
• Reconstituted Synagis® should stand undisturbed at room temperature for a minimum of 20 minutes until the solution clarifies.
• Reconstituted Synagis® should be inspected visually for particulate matter or discoloration prior to administration. The reconstituted solution should appear clear or slightly opalescent (a thin layer of micro-bubbles on the surface is normal and will not affect dosage). DO NOT use if there is particulate matter or if the solution is discolored.
• Reconstituted Synagis® does not contain a preservative and should be administered within 6 hours of reconstitution. Administer immediately after withdrawal from vial. Synagis® is supplied in single-use vials. DO NOT re-enter the vial. Discard any unused portion.

Preparation of Liquid Product for Administration:

• Remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent.
• Both the 50 mg and 100 mg vials contain an overfill to allow the withdrawal of 50 mg or 100 mg Synagis® .
• Synagis® does not contain a preservative and should be administered immediately after withdrawal from vial. Synagis® is supplied in single-use vials. DO NOT re-enter the vial. Discard any unused portion.

To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, sterile disposable syringes and needles should be used. DO NOT reuse syringes and needles.

Synagis® is available in two formulations: a lyophilized powder and liquid solution.

Lyophilized Powder: Synagis® is supplied in single-use vials as lyophilized powder to deliver either 50 mg or 100 mg Synagis® when reconstituted with sterile water for injection.

50 mg vial NDC 60574-4112-1 Upon reconstitution the 50 mg vial contains 50 mg Synagis® in 0.5 mL.

100 mg vial NDC 60574-4111-1 Upon reconstitution the 100 mg vial contains 100 mg Synagis® in 1.0 mL.

Liquid Solution: Synagis® is supplied in single-use vials as a preservative free, sterile solution at 100 mg/mL in 0.5 mL and 1.0 mL to deliver either 50 mg or 100 mg Synagis® , respectively, for IM injection.

50 mg vial NDC 60574-4114-1 The 50 mg vial contains 50 mg Synagis® in 0.5 mL.

100 mg vial NDC 60574-4113-1 The 100 mg vial contains 100 mg Synagis® in 1.0 mL.

Upon receipt and until use, Synagis® should be stored between 2¡C and 8¡C (36¡F and 46¡F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.

Synagis® is a registered trademark of MedImmune, Inc

Manufactured by: MedImmune, Inc, Gaithersburg,MD 20878
U.S. GovÕt. License No. 1252 (1-877-633-4411)

Rev Date: July 23, 2004 SSP04-090

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