Synagis

Limitations of Use:

The safety and efficacy of Synagis have not been established for treatment of RSV disease [see Warnings and Precautions ].

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 ]. 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.

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.

Pregnancy

Lactation

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 ].

Hypersensitivity Reactions

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. Signs and symptoms may include urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotonia, hypotension, and unresponsiveness. 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 anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (e.g., epinephrine) and provide supportive care as required. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis.

Coagulation Disorders

Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder.

RSV Diagnostic Test Interference

Palivizumab may interfere with immunological-based RSV diagnostic tests such as some antigen detection-based assays. In addition, palivizumab inhibits virus replication in cell culture, and therefore may also interfere with viral culture assays. Palivizumab does not interfere with reverse transcriptase-polymerase chain reaction based assays. Assay interference could lead to false-negative RSV diagnostic test results. Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions [see Microbiology ].

Treatment of RSV Disease

The safety and efficacy of Synagis have not been established for treatment of RSV disease.

Proper Administration

The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion.