DO NOT USE FOR CLINICAL PRACTICE
Please use current guidelines available on the UHNM intranet for patient treatment
Please use current guidelines available on the UHNM intranet for patient treatment
Based on NHS England’s commissioning criteria June 2021
DEFINITION
Palivizumab is a monoclonal antibody produced by recombinant DNA technology used to prevent severe disease caused by Respiratory Syncytial Virus (RSV)
INDICATIONS
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
Gestational age at birth (whole weeks) | |||||||
Chronological age (months) |
≤24+0 | 24+1–26+0 | 26+1–28+0 | 28+1–30+0 | 30+1–32+0 | 32+1–34+0 | >34+1 |
<1.5 | |||||||
1.5 to <3 | |||||||
3 to <6 | |||||||
6 to <9 | |||||||
≥9 |
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
PROCEDURE
- 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)
DOCUMENTATION
- 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.