Palivizumab is a monoclonal antibody produced by recombinant DNA technology used to prevent severe disease caused by Respiratory Syncytial Virus (RSV)

High risk – bronchopulmonary dysplasia (BPD) [also known as chronic lung disease (CLD)]

• Moderate or severe BPD in preterm babies defined as:
  • preterm babies with compatible X-ray changes who continue to receive supplemental oxygen or respiratory support at 36 weeks’ post-menstrual age and 
  • in the shaded area in Table 1 (age on 1st October)
• Babies with respiratory disease who are not necessarily preterm but are aged <2 yr and who remain on oxygen on 1st October are considered to be at higher risk. This may include those with conditions including:
  
  • pulmonary hypoplasia due to congenital diaphragmatic hernia
  • other congenital lung abnormalities (sometimes involving heart disease or lung malformation)
  • interstitial lung disease; including those receiving long-term ventilation at the start of the season 

Table 1: Chronological age cut off for palivizumab 

High risk congenital heart disease (CHD) defined as:

• Preterm babies with haemodynamically significant, acyanotic CHD at the chronological ages on 1st October and gestational ages covered by light grey shaded area in Table 1
• Cyanotic or acyanotic CHD plus the following significant co-morbidities, particularly if multiple organ systems are involved:
  • Down’s syndrome
  • preterm delivery (<35 weeks)
  • CLD 
  • pulmonary hypertension
  • immune deficiency – DiGeorge, combined immune-deficiency
  • heart failure – diuretic therapy, oral inotropic therapy
  • cyanosis with SpO₂ <85%
  • those due transplantation or cardiac surgery

The following co-morbidities are NOT acceptable under the guidance (little/no evidence for RSV prophylaxis)

• Haemodynamically insignificant CHD (no therapy)
• Repaired CHD
• Arrhythmias
• Recovered from CLD
• Children aged >2 yr 

Children with severe defects in cell-mediated immunity

• Children aged <2 yr who have severe combined immunodeficiency syndrome (SCID) until immune reconstituted

Children on long-term ventilation (LTV)

• Children aged <2 yr on LTV are eligible if on air entrained LTV at the start of the season 

• Consultant will complete Blueteq form for each patient meeting the criteria above
  • if the consultant considers a baby outside of the above criteria would benefit from palivizumab treatment, an application for approval to be made through the regional individual funding request process
• 5 doses monthly in RSV season at the beginning of October, November, December, January and February. If the RSV season is prolonged the course may be extended to a maximum of 7 doses in total
  • give appointment for subsequent doses at palivizumab clinic (if held)
  • where possible, administer first dose before start of RSV season
  • 15 mg/kg by IM injection into antero-lateral aspect of thigh
• Order palivizumab injection from local community or hospital pharmacy (this can take some days) 
• Palivizumab must be stored at 2–8°C. Full administration instructions are provided in the ‛Summary of product characteristics’ (SPC)
• Split between 2 sites if >1 mL (final concentration when reconstituted 100 mg/mL)

• After immunisation, document the following in case notes as well as in Child Health Record (Red Book):
  • consent gained from parents
  • vaccine given and reasons for any omissions
  • site of injection(s) in case of any reactions
  • batch number of product(s)
  • expiry date of product(s)
  • legible signature of person administering immunisations
  • adverse reactions
• Sign treatment sheet
• Update problem sheet with date and immunisations given
• Document all information on discharge summary and medical case notes including recommendations for future immunisations and need for any special vaccinations, e.g. influenza, palivizumab, etc.