Introduction

Respiratory Syncytial Virus (RSV) is one of the most common causes of lower respiratory tract infections in children at high risk of respiratory disease. It is associated with increased morbidity amongst preterm infants and babies born with chronic health conditions such as respiratory and/or cardiac complications. 

Palivizumab provides passive immunity against RSV infection and has been shown to decrease hospitalisation for RSV related illness1. There is currently no vaccine to protect against RSV.  For patients who have been admitted to hospital for RSV infection, the incidence of an ICU admission related to RSV infection is decreased in patients receiving 4 weekly Palivizumab. 

The Royal Children’s Hospital (RCH) funds Palivizumab for selected cardiology patients and other at-risk groups and administration is coordinated by the RCH Immunisation Service.  Palivizumab is given as a course of up to 5 intramuscular injections at 1-month intervals throughout the RSV season. The RSV program at RCH generally begins in May each year and concludes at the end of September.

This guideline is restricted to use by Medical and Pharmacy staff and nurse immunisers working in the Immunisation Drop-in Centre (DIC) at RCH. The guideline applies to neonate/infant inpatients or outpatients attending RCH and can be administered by accredited nurse immunisers in the DIC with a Drug Usage Committee (DUC) approved order on EMR. 
Palivizumab can be given from birth. (Usually given in first year of life)

Aim

The aims of this guideline are;

• To ensure that the nurse immunisers at RCH are providing safe and effective administration of Palivizumab, according to the relevant legislation, Best Practice, the Australian Immunisation Handbook Guidelines and The Royal Children’s Hospital Clinical Practice Guidelines.
  
• To ensure that parents receive consistent, accurate and reliable information about the procedure, including the potential risk and benefits, such as possible adverse events (AE), how common they are and how to report AE and get advice.
  
• To streamline current practices to minimise excessive wait times and potential exposure to further pathogens for high-risk children.
  

Definition of Terms

• Palivizumab – humanized monoclonal antibody (IgG) directed against an epitope in the A antigenic site of the F protein of RSV.  It is used in the prevention of Respiratory syncytial virus.  Palivizumab neutralizes and inhibits fusion of RSV with the host cell, preventing its replication.
• Passive Immunity – can occur naturally when maternal antibodies are transferred to fetus or can be artificially induced by the transfer of  readymade antibodies such as administration of blood products
• Nurse Immuniser – Division 1 registered Nurse who has completed an approved immunisation course and has approval to administer scheduled vaccines under the secretary approval under regulation 5(3) Drugs, Poisons and Controlled Substances Regulations 2006.
• Cold Chain – cold chain is process of transporting and storing vaccines within the temperature range of +2° - +8°. Maintenance of cold chain is essential for maintain vaccine potency and effectiveness.
• Therapy Plan – Scheduled Order set that includes all doses for the season at the appropriate intervals.

Assessment

Eligibility for Palivizumab is considered by the Drug Usage Committee (DUC) on a case-by-case basis.  Criteria for use is established following consultation with relevant clinicians, and examples of approved patients include:

• Preterm infants born before 29 weeks 0 days gestation
• Preterm infants born before 32 weeks 0 days gestation with chronic lung disease of prematurity or congenital heart disease
• Infants with haemodynamically significant congenital heart disease
• Children with anatomic pulmonary abnormalities or neuromuscular disorder that impairs the ability to clear secretions from the lower airways
• Immunocompromised children assessed on an individual basis
  

Management

Dosage

• The recommended dose of Palivizumab is 15mg/kg by intramuscular (IM) injection and can be given from birth

 (See note below)

• Palivizumab requires a Therapy Plan ordered on EMR by the treating team.
• The child’s most recent weight must be recorded in EMR so that an accurate Palivizumab dose can be confirmed.
• Parents are asked to call the immunisation service with the child’s current weight on the Monday of the week the child will receive the Palivizumab.  The current weight of an inpatient should be documented on EMR

Note: Dose 2 is given 3 weeks after dose 1 and then 4 weekly for the remainder of RSV season. 

If the patient tests positive for RSV infection, then a 3 month delay between infection and the Palivizumab is required. This gap can be shortened in immunocompromised patients. Speak to the Immunisation Service for case by case discussion.  

Prescribers can order Palivizumab as a once off (Stat order) if Palivizumab is not required for the entire duration of the RSV season. 

The RSV therapy plan can also be ceased at the discretion of the prescriber in certain circumstances i.e cessation of heart failure medications and post corrective cardiac surgery.  The Immunisation Drop-in centre must be informed in these circumstances.

Preparation

Palivizumab for injection is available as:

• 50mg vial (0.5mL), (concentration 100mg/mL)
• 100mg vial (1mL), (concentration 100mg/mL)

Ensure the following steps are taken:

• Ensure the Palivizumab vial is within expiry date and cold chain has been maintained
• Perform hand hygiene
• Clean trolley or work surface with detergent and water or wipe
• Identify and collect the appropriate injection equipment for the Palivizumab to be administered
• Perform hand hygiene
• Remove the dust cover of the Palivizumab and disinfect the vial top with a 70% alcohol antiseptic wipe and allow to dry
• Peel open sterile equipment and protecting key parts draw up the dose
• Two patient doses may be withdrawn from the vial as part of an exceptional response to prevent wastage of the product
• In this instance, a new 19 gauge needle and 1-3 mL syringe should be used for drawing up each dose and any remaining product discarded.  The vial top must be disinfected before drawing up each dose.
• The syringes must be labelled with;
• Extreme care with aseptic technique is required to avoid contamination
• Prepare patient and safely position, including distraction techniques
• Perform hand hygiene
• Provided the skin is visibly clean, there is no need to wipe it with an alcohol swab
  

Note: RSV does not contain a preservative and should be administered immediately after drawing up the dose

See also RCH Procedure document Single use of injectable medicines and fluids available at Policies and Procedures : Single use of injectable medicines and fluids (rch.org.au)

Administration

• Palivizumab is given as an IM injection into the vastus lateralis muscle in the anterolateral aspect of the thigh
• Refer to the intramuscular injection guideline to facilitate the administration of IM injections
  

Procedural Pain Management

Injections can result in distress and anxiety for infants, children and their parents. It is important that effective pain management strategies are used during injection procedures. Some strategies that are recommended during administration of the Injection include:

• Oral sucrose (infants) – for more information please see Sucrose (oral) for procedural pain management in infants nursing guideline
• Breastfeeding
• Shaking a noisy toy
• Topical anaesthetic agents, such as AnGel (not for premature infants or those less than 1 month of age) or EMLA cream (not for preterm infants with gestational age less than 37 weeks) can also be used.

https://www.mimsonline.com.au.acs.hcn.com.au/Search/FullPI.aspx?ModuleName=Product%20Info&searchKeyword=emla&PreviousPage=~/Search/QuickSearch.aspx&SearchType=&ID=19010001_2

See also RCH clinical guideline document available at http://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Procedural_Pain_Management/

Post Vaccination

Immediate after care

• Dispose of clinical and sharps waste
• Cover the injection site with cotton wool and tape as needed
• Gently apply pressure for 1-2 minutes (do not rub injection site, as it may lead to localised irritation)
• As with any IM injection, caution should be used when administering Palivizumab to patients with thrombocytopenia or anticoagulation.  Firm pressure should be applied for approximately 5-10 minutes.
• After procedure perform hand hygiene
• Inform parent to remain in the hospital with the child for at least 15 minutes after receiving Palivizumab (to observe for any immediate adverse event)
  

Adverse Events

• An adverse event is any untoward medical occurrence that follows medication administration and does not necessarily have a causal relationship with the usage of the Palivizumab.
• The most serious adverse event is anaphylaxis. Nursing staff must be aware of anaphylaxis management.
• Any adverse event should be reported to the Immunisation service and can be contacted on 1300 882 924 (Option 3). 
  

Palivizumab Adverse reactions:

• Common (>1%)

Fever, rash, rhinitis, wheeze, cough, diarrhoea, injection site reaction

• Infrequent (.01-1%)

Anaemia, elevated liver enzymes

• Rare (<0.1%)

Hypersensitivity (including anaphylaxis)

Documentation requirements

• The Palivizumab Therapy plan will be documented on the neonates/infants EMR.
• After the dose has been given the order will need to be completed and signed off on EMR then recorded in the Infants Child Health record book.
• Details which should be recorded include
  • Medication given (Including brand name, batch number, dose number)
  • Date and time of injection
  • Site of administration
  • Name of the person who administered the injection.

Please remember to read the disclaimer. 

The development of this nursing guideline was coordinated by Sonja Elia, Nurse Practitioner and Manager, Immunisation, and approved by the Nursing Clinical Effectiveness Committee. Updated December 2023.