Palivizumab for at-risk patients

  • 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)


    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.


    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



    • 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.


    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 (


    • 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.

    See also RCH clinical guideline document available at

    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. 

    Evidence Table 


    Source of Evidence

    Key findings and considerations 
    Garegnani L, Styrmisdottir L, Roson Rodriguez P, Escobar Liquitay CM, Esteban I and Franco JVA (2021).  Palivizumab for preventing severe respiratory syncytial virus (RSV) infection in children.  Cochrane database of systematic reviews.
    Systematic review
    • Prophylaxis with palivizumab reduces hospitalization due to RSV infection and results in little to no difference in mortality or adverse events.    
      Munoz FM, Ralston SL, Meissner HC (2017).  RSV recommendations unchanged after review of new data, American Academy of Pediatrics, accessed 21/08/23
      RSV recommendations unchanged after review of new data | American Academy of Pediatrics (

      Expert opinion
      • Policy statement are evidenced based and reviewed every 3 years. Evidence is obtained from a systematic review of all recent and older peer reviewed literature relating to RSV disease in infants.
      • Outlines the recommended high risk infant criteria
      • Outlines recommended time intervals and length of RSV treatment. 15mg/kg per dose during RSV season up to a maximum of 5 doses
        Australian Medicines Handbook Pty Ltd 2021, Palivizumab – Australian Medicines Handbook (online), accessed 21/08/23

        Randomised controlled trial
        • Outlines Indications for RSV
        • Provides evidence from 2 randomised control trials that Palivizumab reduced the rate of hospitilisation due to RSV infection in the identified cohort of infants
        • Provides guideline for a dosage of 15 mg/kg given Intramuscularly in the anterolateral thigh 4weekl
        • Identifies the splitting the palivizumab dose into 2 (or more) injections if the volume is >1ml
        King Edward Memorial Hospital & Perth Children’s Hospital Neonatology Medication Monograph Palivizumab 2019 accessed 21/08/23
        Palivizumab Neonatal (
        Expert opinion
        • Describes indications for use, precautions, dosage, adverse reactions
         Department of Health Victoria 2021, Mims online, accessed 21/08/23
        Abbreviated PI (
        Expert opinion
        • Describes indications for use, contraindications, precautions, adverse reactions and interactions
        Elia,S (2022) Immunisation Service – RSV Immunoglobulin Report – November 2022 The Royal Children’s Hospital Melbourne Expert opinion
        • Provides results including data of number of inpatients and outpatients who received Palivizumab during the 2020 season
        • Provides data of RSV admissions to RCH in 2020 RSV season
        • Provides data on cost savings
        Manzoni P, Paes B, Lanctot KL, Dall’Agnola A, Mitchell I, Calabrese S, Maule M, Girardi E, Harimoto T and Li A (2017). Outcomes of Infants receiving Palivizumab Prophylaxis for Respiratory Syncytial Virus in Canada and Italy. The Pediatric Infectious Disease Journal, 36(1): January 2017. Accessed 21/08/23 Case control study
        • Describe the incidence of RSV hospitalisations in a large, cohort of Palivizumab recipients to compare the effectiveness of Palivizumab in premature infants versus those who received Palivizumab for other underlying conditions
        • Were factors related to the timing of Palivizumab administration and the number of doses administered associated with treatment ineffectiveness
          National Health and Medical Research Council, The Australian Immunisation 
          Handbook, accessed 21/08/23
          Vaccination procedures | The Australian Immunisation Handbook (
          Expert opinion
          • Evidence is based  from systematic reviews and best available scientific evidence
          • Outlines vaccination procedures when giving intramuscular injections to infants