Synagis (palivizumab) for RSV prophylaxis in NICU graduates

(Version 1.0  05/22/02 - 12/01/02)

Monthly injections of palivizumab (Synagis), a monoclonal antibody preparation against the RSV virus, have been shown to decrease the incidence of severe RSV disease by 55% in high-risk populations.

"High-risk" patients who should receive Synagis include:

1. Infants less than 24 months old with chronic lung disease who require supplemental oxygen or other medical therapy for their CLD within the 6 months preceding RSV season.
2. All infants born at < 32 weeks gestational age who are less than 6 months of age at the onset of RSV season. Infants born at < 28 weeks gestational age may benefit from RSV prophylaxis up to 12 months of age.
3. Infants born at 32 - 35 weeks gestational age may be considered for RSV prophylaxis if they have additional risk factors for severe RSV infection: multiple births, daycare, young siblings, smoking in the home.

VUMC data suggests that infants with Trisomy 21 are also at risk for severe RSV disease as are infants with significant neuromuscular disorders. These patients may also be considered candidates for Synagis.

Synagis should not be given to infants with congenital heart disease, particularly cyanotic congenital heart disease, until further data are available.

Synagis is given in 15 mg/kg doses IM q 4 weeks.

Administration begins with the onset of RSV season and concludes at the end of RSV season. In Tennessee, RSV season usually runs from October through April.

The first dose of Synagis should be administered in the NICU prior to discharge home.

Synagis is packaged in 100mg vials, which must be used once opened within 6 hours. Given the small size of NICU patients, one vial may provide more than one patient’s dose. Given the high cost of Synagis, administration of the drug should be coordinated so that the vial can be shared between multiple patients. The NICU case-managers can help with this coordination.

Prior to discharge, parents should be educated about RSV, its potential severity, and their child’s indications for Synagis. The parents must sign a discharge form stating that they understand the physician’s instructions regarding monthly Synagis injections during RSV season.

The IMpact –RSV Study Group. Palivizumab, a humanized Respiratory Syncytial Virus monoclonal antibody, reduces hospitalization from Respiratory Syncytial Virus infections in high-risk infants. Pediatrics 1998; 102: 531-537.

AAP. Prevention of Respiratory Syncytial Virus infections: Indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics 1998; 102: 1211-1216.