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.
Nirsevimab (Beyfortus™) is a long-acting monoclonal antibody given to infants for passive immunisation against RSV infection. It has been shown to protect infants against hospitalisation for RSV-associated lower respiratory tract infection and against very severe RSV-associated lower respiratory tract infection.
The Department of Health, Victoria funds Nirsevimab and administration for outpatients is coordinated by the Royal Children’s Hospital (RCH) Immunisation Service. Nirsevimab is given as a single dose as the infant enters their first RSV season. The RSV season generally begins 1st April each year and concludes at the end of September.
Nirsevimab can be given from birth.
Aim
The aims of this guideline are;
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.
This guideline is restricted to use by Medical, Nursing and Pharmacy staff working at RCH. The guideline applies to neonate/infant inpatients or outpatients attending RCH and can be administered by Medical or Nursing staff with an order on EMR.
Definition of Terms
Assessment
Nirsevimab is recommended for:
* The increased risk factors for severe RSV disease include:
**The medical factors for severe RSV disease in the 2nd RSV season
Notes:
- If the patient tests positive for RSV infection, they can receive RSV specific monoclonal antibodies once recovered.
Contraindications:
The only absolute contraindications to RSV monoclonal antibodies are:
^Components of the monoclonal antibody are: histidine, histidine hydrochloride, monohydrate, arginine hydrochloride, sucrose, polysorbate 80 and water.
For more information please visit https://immunisationhandbook.health.gov.au/contents/vaccine-preventable-diseases/respiratory-syncytial-virus-rsv#rsvspecific-monoclonal-antibodies-infants-and-children-aged-24-months
Management
Dosage
Nirsevimab dosage is based on body weight and is administered as a intramuscular (IM) injections.
For infants born during or entering their first RSV season the recommended dose of Nirsevimab is:
Body weight at time of dosing (first RSV season)
| Recommended Dosage
|
Less than 5 kg
| 50 mg by IM injection (purple plunger rod)
|
5 kg and greater
| 100 mg by IM injection (light blue plunger rod)
|
Nirsevimab is also recommended for children up to 24 months of chronological age who remain at increased risk for severe RSV disease in their second RSV season, see above for risk factors.
For infants entering/in their second RSV season the recommended dose of Nirsevimab is:
Body weight at time of dosing (second RSV season)
| Recommended Dosage
|
Less than 5 kg
| 50 mg by IM injection (purple plunger rod)
|
5 kg - 9.99 kg
| 100 mg by IM injection (light blue plunger rod)
|
10 kg or more
| 200 mg; administered as two IM injections (2 x 100 mg) at different injections sites (preferably separate limbs) during the same visit.
|
For more information regarding dosage of Nirsevimab please see Respiratory syncytial virus (RSV) - The Melbourne Vaccine Education Centre (MVEC).
For inpatients, Nirsevimab requires a medication order on the EMR.
The child’s most recent weight must be recorded in EMR so that an accurate Nirsevimab dose can be confirmed.
- For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of Nirsevimab is recommended as soon as the child is stable after surgery to ensure adequate Nirsevimab serum levels.
- First RSV season:
- If surgery is within 90 days after receiving Nirsevimab, the additional dose should be based on body weight at the time of the additional dose (see table above).
- If more than 90 days have elapsed since receiving Nirsevimab, the additional dose should be 50 mg regardless of body weight.
- Second RSV season:
- If surgery is within 90 days after receiving Nirsevimab, the additional dose should be 200 mg, regardless of body weight.
- If more than 90 days have elapsed since receiving Nirsevimab, the additional dose should be 100 mg, regardless of body weight.
Preparation
Nirsevimab for injection is available as:
Please note: Nirsevimab
prefilled syringe is for single use in one patient only. Do not split the
100mg pre-filled syringe into 2 x 50mg doses. Do not combine 2 doses into one syringe.
Ensure the following steps are taken:
Hold the syringe body with one hand and carefully pull the needle cover straight off with the other hand. Do not hold the plunger rod while removing the needle cover or the rubber stopper may move. Do not touch the needle or let it touch any surface. Do not recap the needle or detach it from the syringe.
- Visually
inspect Nirsevimab for particulate matter and discolouration prior to
administration. Nirsevimab is a clear to opalescent, colourless to yellow
solution. Do not use if the liquid is cloudy, discoloured or it contains
large particles or foreign particulate matter. Do not use if the prefilled
syringe has been dropped or damaged.
Prepare patient and safely position, including distraction techniques.
Administration
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:
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
Adverse Events
Nirsevimab Adverse reactions:
- Uncommon (0.1% - <1%)
- Fever, rash, injection site reaction
Documentation
requirements
- The Nirsevimab order will be documented in 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.
- It will also need to be recorded on the Australian Immunisation Register (AIR). Once signed off on the MAR, an inbasket message is sent to the Immunisation centre so that the dose can be recorded on AIR.
- Details which should be recorded include:
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 March 2025.
Evidence Table
Reference
|
Source of Evidence
|
Key
findings and considerations
|
Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, Kaiser F, Cohen R, Pinquier D, Felter CT, Vassilouthis NC, Jin J et al., for the HARMONIE Study Group. Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. N Engl J Med. 2023;389:2425-2435 https://www.nejm.org/doi/full/10.1056/NEJMoa2309189, accessed 21/10/2024
|
Systematic review
|
- Prophylaxis with Nirsevimab reduces hospitalization due to RSV lower respiratory tract and reduces very severe infection. No safety concerns were identified in the trial. Prophylaxis with palivizumab reduces hospitalization due to RSV infection and results in little to no difference in mortality or adverse events.
|
NSW RSV Prevention Program – Frequently asked questions for health professionals. Accessed 5/3/25. https://www.health.nsw.gov.au/immunisation/Pages/nirsevimab-professionals.aspx
|
Expert opinion |
- Frequently asked questions answered to guide health professionals in administering Nirsevimab
|
Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, +11 for the MELODY Study Group. Nirsevimab for Prevention of RSV in Health Late-Preterm and Term Infants. New Engl J Med. 2022;386(9):837-846. DOI: 10.1056/NEJMoa2110275, accessed 21/10/2024
|
Randomised controlled trial
|
- 1490 infants randomly assigned to receive nirsevimab or placebo prior to RSV season.
- Nirsevimab protected infants from medically attended RSV associated lower respiratory tract infection
|
Simoes EA, Madhi SA, Muller WJ, Atanasova V, Bosheva M et al. Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomized controlled trials. Lancet Child Adolesc Health. 2023;7(3):180-189. Accessed 21/10/2024
|
Meta-analysis |
Safety profile of nirsevimab consistent with that observed in palivizumab trials - Most adverse events were mild or moderate in severity and considered unrelated to nirsevimab
|
Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: Recommendations of the Advisory Committee on Immunization Practices – United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72(34):920–25. doi: 10.15585/mmwr.mm7234a4. Accessed 21/10/2024
|
Expert opinion |
- Advisory Committee on Immunization Practices recommended nirsevimab for infants aged <8 months born during or entering their first RSV season and for infants and children aged 8-19 months who are at increased risk of severe RSV disease entering their second RSV season.
|
Australian Government, Department of Health and Aged Care. Australian Technical Advisory Group on Immunisation (ATAGI) Clinical Advice. 26 March 2024. Statement of the use of Nirsevimab for prevention of severe disease due to respiratory Syncytial Virus (RSV) in infants.
|
Expert opinion |
- Key points about RSV disease, about Nirsevimab – uses, availability, dosing, timing, safety, efficacy and co-administration with other vaccines.
|
National Health and Medical Research Council, The Australian Immunisation Handbook, accessed 21/10/24
https://immunisationhandbook.health.gov.au/
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Expert opinion
|
- Evidence is based from systematic reviews and best available scientific evidence.
- Outlines overview, recommendations, dosage and administration as well as contraindications and precautions.
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