Included as part of the PRECAUTIONS section.

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 transcriptasepolymerase 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.

Patient Counseling Information

• “See FDA-approved patient labeling (PATIENT INFORMATION)”

The healthcare provider should discuss the potential benefits and risks of Synagis with the parents or guardians of Synagis recipients. Parents or guardians should be informed of the possible side effects of Synagis and of the signs and symptoms of potential allergic reactions and should be advised of the appropriate actions. Parents or guardians should understand the dosing schedule and the importance of compliance with the full course of therapy.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, mutagenesis, and reproductive toxicity studies have not been performed.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Synagis is not indicated for adult usage. It is not known whether Synagis can cause fetal harm or could affect reproductive capacity when administered to a pregnant woman.

Animal Data

Animal reproduction studies have not been conducted.

Pediatric Use

The safety and effectiveness of Synagis in children greater than 24 months of age at the start of dosing have not been established.

Last reviewed on RxList: 4/17/2012
This monograph has been modified to include the generic and brand name in many instances.