Clinical Guidelines (Nursing)

Palivizumab for at-risk patients

  • Introduction

    Aim

    Definition of Terms

    Assessment

    Management

    Documentation

    Evidence Table

    References

    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 illness. 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 begins in May each year and concludes at the end of September.

    This guideline is intended for use by Medical and Pharmacy staff and nurse immunisers working in the Immunisation Drop in Centre (DIC) at RCH. The guideline applies to neonate/infants inpatient or outpatients attending RCH and can be administered by approved 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, how common they are and what they should do about them.
    • 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
    • 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
    • Immunisation Nurse – 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 with or without chronic lung disease of prematurity or congenital heart disease
    • Infants with haemodynamically significant congenital heart disease
    • Children with anatomic pulmonary abnormalities or neuromuscular disorder
    • 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. 

    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 2% chlorhexidine and 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;
      • Date and time of preparation
      • Patient’s name and identification (UR number)
      • Signatures of two checking medical, pharmacy or nursing staff
    • 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 Multi-use of Pharmaceutical injection products, sealed vials and bags available at http://www.rch.org.au/policy/policies/Multi-use_of_pharmaceutical_injection_products,_sealed_vials_and_bags/

      Administration:

      • Palivizumab is given as an IM injection into the vastus lateralis muscle in the anterolateral thigh
      • If the dose is greater than 1 ml the volume to be injected should be divided into 2 injections

      Intramuscular injection technique 

      • For IM injection, use a 23 gauge 25 mm needle
      • Position the limb so as to relax the muscle into which the Palivizumab will be injected
      • Pierce the skin at an angle of 90° to the skin, so the needle can be safely inserted to the hub
      • It is not necessary to draw back on the syringe plunger before injecting the Palivizumab

      Intramuscular injection technique

      Photo courtesy Lloyd Ellis, The Royal Children’s Hospital, Victoria (pg. 80 of Australian Immunisation Handbook, 10th ed. 2013)

      Position for infants < 12 months

      Position the infant in a semi-recumbent position on the lap of the parent/carer (see figure below) this position is also suitable for young children.
      Position for infants

      Photo courtesy Dr Joanne Molloy, Victoria (pg 75 of Australian Immunisation handbook, 10th ed. 2013)

      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)
      • Breastfeeding
      • Shaking a noisy toy
      • Topical anaesthetic agents, such as AnGel or EMLA cream can also be used.

      See also RCH nursing 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 the 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 2). 

        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.

        Evidence Table

        The evidence table for this guideline can be found here. 

        References

        • American Academy of Pediatrics 2014, Updated Guidance for Palivizumab Prophylaxis Among
          Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection accessed 16/07/18
          <http://pediatrics.aappublications.org/content/pediatrics/134/2/415.full.pdf
        • Australian Medicines Handbook Pty Ltd 2018, Palivizumab – Australian Medicines Handbook (online), accessed 16/07/18
          https://amhonline.amh.net.au.acs.hcn.com.au/chapters/anti-infectives/antivirals/other-antivirals/palivizumab
        • Children’s health Queensland Hospital and health Service 2017, Palivizumab for RSV prophylaxis in high risk paediatric patients Document ID CHQ-GDL -01071 version no. 3
        • Department of Health Victoria 2018, Mims online, accessed 16/07/18 
          https://www.mimsonline.com.au/Search/FullPI.aspx?ModuleName=Product Info&searchKeyword=Palivizumab&PreviousPage=~/Search/QuickSearch.aspx&SearchType=&ID=4849000
          2_2
        • Elia,S (2016) Immunisation Service – RSV Immunoglobulin Report – November 2016 The Royal Children’s Hospital Melbourne
        • 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 15/07/2019
          MedImmune 2018, Synagis Palivizumab, accessed 16/07/18 < https://www.synagis.com/>   
        • National Health and Medical Research Council 2017, The Australian Immunisation Handbook, accessed16/07/18<http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home~handbook10part5~handbook10-5-1>
        • The Royal Childrens Hospital Melbourne n.d, Respiratory syncytial Virus RSV, accessed 16/07/18 <http://www.rch.org.au/washup/for_health_professionals/Respiratory_Syncytial_Virus_RSV/>
        • The Royal Children’s Hospital Melbourne 2018, Multi-Use of pharmaceutical injection products, sealed vials and bags, accessed 16/08/18 <http://www.rch.org.au/policy/policies/Multi-use_of_pharmaceutical_injection_products,_sealed_vials_and_bags/>
        • The Royal Children’s Hospital Melbourne 2018, Paediatric Injectable Guidelines, accessed 16/07/18 <http://www.rch.org.au/pig/>
        • The Victorian Government Melbourne 2012, Secretary Approval Nurse Immuniser accessed 16/07/18 <https://www2.health.vic.gov.au/about/publications/factsheets/Secretary%20Approval%20-%20Nurse%20Immuniser>

        Please remember to read the disclaimer

        The development of this nursing guideline was coordinated by Nadine Henare, Nurse Coordinator Immunisation, and approved by the Nursing Clinical Effectiveness Committee. Updated August 2018.