Synagis (palivizumab) for RSV prophylaxis in NICU graduates

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.

In the NICU, all eligible patients should receive their FIRST dose of Synagis^® prior to discharge.

• Infants transferred from the NICU to the floor will be given their first dose of Synagis^® prior to discharge if the patient meets NICU criteria.

Infants Eligible for a Maximum of 5 Doses (1^st dose only at VCH)

1.      Children < 24 months with CLD of prematurity requiring medical therapy within 6 months of the start of RSV season

2.      Infants born at < 32 weeks (31 weeks, 6 days or less)

• < 28 weeks:  During RSV season of 1^st 12 months of life

• 29 to < 32 weeks: During RSV season if begins during 1^st 6 months of life

3.      Infants with congenital abnormalities of the airway or neuromuscular disease

• Born at < 35 weeks: During RSV season of 1^st 12 months of life

4.      Children < 24 months with hemodynamically significant CHD

• Those receiving medications to control congestive heat failure

• Those with moderate-severe pulmonary hypertension

• Those with cyanotic heart disease

• Dose should be given after bypass

Infants Eligible for a Maximum of 3 Doses (1^st dose only at VCH)

1.      Carefully consider use in infants born at 32 to < 35 weeks gestation (high cost vs. risk)

• Prophylaxis until 3 months of age only

• Reserve for infants at greatest risk of severe infections and born less than 3 months before or during RSV season (at least 1 of 2 risk factors must be met: child care attendance, school-aged siblings/other children in home < 5 years old)

A multi-center trial has demonstrated that Synagis administration is safe for infants with severe congenital heart disease and decreased the incidence of hospitalization for RSV by 45% in this population.

Therefore, premature infants or infants with chronic lung disease who meet the above criteria should receive Synagis even if they also have a cardiac lesion. 

Potential Synagis administration in patients with hemodynamically significant CHD prior to discharge should be discussed with cardiology.  Infants with mild or hemodynamically insignificant heart disease (a small VSD, secundum ASD, mild pulmonic stenosis, etc.) or children with lesions adequately corrected by surgery generally should not need immunoprophylaxis.

Further recommendations for the use of Synagis in patients with CHD await the FDA and peer-review of published data from the MI-CP048 trial.

Administration of Synagis

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.  AAP Red Book now recommends beginning treatment on 1 November and limiting number of doses to 5 maximum.

The first dose of Synagis should be administered in the NICU prior to discharge home with coordination by the NICU case managers.

Synagis is packaged in 100mg vials, which must be used once opened within 6 hours. 

Discharge planning

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.

Recommendations for RSV prophylaxis should also be included in every patient’s discharge summary year-round, whether the patient is being back-transported or going home, to facilitate effective communication with the patient’s pediatrician and improve compliance with the prophylactic regimen.

Approved at the Clinical Division Meeting 9/24/01. Revisited at the Collaborative Pathways meeting 5/22/02, 12/01/02 and again 10/29/2009

References

Meissner HC. Study: palivizumab safe for children with CHD. AAP News 2002; 21 (6): 271

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.