Definition of Terms
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. 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’s 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)
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
- 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.
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
Palivizumab can be given at the same time as routine vaccinations on the National Immunisation Program (NIP). Different sites must be used.
- 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.
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 is listed in Table 1 of the RCH Hazardous Drugs list, and as
a result a respiratory mask and protective eyewear must be worn for tasks that
pose an increased risk of internalization or splash. See Hazardous Medicines – Safe
handling of (RCH access only).
Palivizumab for injection is available as:
- 50mg vial (0.5ml), (concentration 100mg/ml)
- 100mg vial (1ml), (concentration 100mg/ml)
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;
- 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 Single use of injectable medicines and fluids available at Policies and Procedures : Single use of injectable medicines and fluids (RCH access only).
- 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 given as a divided dose
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
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.
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)
- Shaking a noisy toy
- Topical anaesthetic agents, such as AnGel or EMLA cream can also be used.
See also RCH nursing clinical guidelines: Procedural Management, Breastfeeding Support, and Sucrose for infants.
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)
- 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)
- 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.
The evidence table for this guideline can be found here.
- Munoz FM, Ralston SL, Meissner HC (2017). RSV recommendations unchanged after review of new data, American Academy of Pediatrics, accessed 20/07/21
RSV recommendations unchanged after review of new data | American Academy of Pediatrics (aappublications.org)
- Australian Medicines Handbook Pty Ltd 2021, Palivizumab – Australian Medicines Handbook (online), accessed 20/07/2021
- King Edward Memorial Hospital & Perth Children’s Hospital Neonatology Medication Monograph Palivizumab 2019 accessed 20/07/2021
Palivizumab Neonatal (health.wa.gov.au)
- Department of Health Victoria 2021, Mims online, accessed 20/07/21
Abbreviated PI (mimsonline.com.au)
- Elia,S (2020) Immunisation Service – RSV Immunoglobulin Report – November 2020 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
- National Health and Medical Research Council, The Australian Immunisation Handbook, accessed 20/07/21 Vaccination procedures | The Australian Immunisation Handbook (health.gov.au)
- The Royal Childrens Hospital Melbourne, Respiratory syncytial Virus RSV, accessed 20/07/21 https://www.rch.org.au/washup/for_health_professionals/Respiratory_Syncytial_Virus_RSV/
- The Royal Children’s Hospital Melbourne 2020, Single use of injectable medicines and fluids, accessed 20/07/21 https://www.rch.org.au/policy/policies/Single_use_of_injectable_medicines_and_fluids/
- The Royal Children’s Hospital Melbourne 2020, Paediatric Injectable Guidelines online, accessed 20/07/21 https://pig.rch.org.au/monographs/palivizumab/
- The Victorian Government Melbourne 2017, Secretary Approval Nurse Immuniser accessed 20/07/21
Please remember to read the disclaimer.
development of this nursing guideline was coordinated by Sonja Elia, Nurse Practitioner and Manager, Immunisation,
and approved by the Nursing Clinical Effectiveness Committee. Updated August 2021.