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Paediatric pathway for administration of Sotrovimab

What's New

16 & 17 year olds will require individual discussion with ID.

Responsible consultant/team
  • Assesses the patient via telephone, information gathers to help assess the patient’s risk of severe COVID-19 (see resources), completes the paediatric nMAB MDT referral proforma (appendix 2).
  • Uploads the completed proforma to the Teams channel and to Clinical Portal.
  • If decision to treat, communicates this to the patient, takes and documents verbal consent on Clinical Portal. Contacts Clinical Decision Unit charge nurse to arrange admission (0141 4524672). Contacts the PID pharmacist in hours (84987), or the on-site pharmacist weekends/bank holidays*.
  • Takes responsibility for administration, i.e., clerks, examines and cannulates the patient, takes sample for SARS-CoV-2 IgG (do not need result prior to administration) and prescribes Sotrovimab in line with the monograph (appendix 1).
  • Patients to be monitored one hour post infusion. Medical team reviews prior to discharge, safety nets (refer to the CAS for possible adverse reactions, link below).
  • ‘Outcomes’ patient on the Trakcare ‘Paediatric IV’ worklist.
  • Sends GP discharge letter.
  • Arranges telephone follow-up after 48hrs.

*Pharmacy opening hours: Monday – Friday 9am – 5pm. Saturday & Sunday 9am – 1pm.
Bank holidays 9am – 1pm. 

Role of the Paediatric Infectious Diseases Team

Accesses emails between 9am-5pm Monday to Friday and runs a daily MDT to discuss cases at 12:30 via Microsoft Teams.

Stores completed patient proforma on the confidential Microsoft Teams channel and records patient details in the Paediatric nMABs database.

Role of the Clinical Decision Unit Team

Liaises with RHC hospital co-ordinator to arrange a bed space and nursing support for treatment.

Informs ED of expected admission of SARS-CoV-2 PCR positive patient.

Appendix 1: Sotrovimab (Xevudy)

 Sotrovimab (Xevudy)

 Preparations available

Xevudy (sotrovimab) 500mg/8ml concentrate for solution for infusion

 Dose

All patients >12yrs and >40kg

A single dose of 500mg, given by IV infusion

 Methods of administration

Intravenous (IV) infusion over 30 minutes

The final preparation for infusion must be administered via a 0.2 micron low protein binding in-line filter supplied by pharmacy with the Sotrovimab.

Do NOT administer as an IV push/bolus or via any other route.

Compatibility and stability

Fluids

0.9% sodium chloride OR 5% glucose

Drugs (Y-site compatibility)

Sotrovimab should be given through a dedicated line and should not be mixed/administered with other medicinal products.

Stability

The diluted solution is intended to be used immediately.  If immediate administration is not possible the diluted solution may be stored:

  • At room temperature (up to 25ºC) for up to 6 hours

OR

  • Refrigerated (2ºC-8ºC) for up to 24 hours from the time of dilution to the end of administration

Protect from light.

pH &  Osmolarity

pH 6 (undiluted)

290mOsm/kg (undiluted)

 Preparation and administration

Dilution and administration instructions

  • Using ANTT withdraw 8ml from the vial of sotrovimab and add directly to a 100ml infusion bag of either sodium chloride 0.9% OR glucose 5%
  • Discard any unused portion left in the vial.  Vials are designed for single use only.
  • Prior to infusion gently rock the infusion bag back and forth 3-5 times. Avoid forming air bubbles.
  • DO NOT INVERT OR SHAKE THE BAG.
  • Administration is via an IV infusion set with standard bore tubing. Prime the infusion set and administer as a single IV infusion over 30minutes.  A 0.2micron low-protein binding in-line filter is required for administration. Supplied by pharmacy with Sotrovimab.

 Points to note

  • Administer ONLY in an area where full resuscitation facilities are available
  • Do not use if visible damage to vial or if particulate matter.

Adverse reaction and suggested monitoring

  • Hypersensitivity reactions including anaphylaxis can occur. These typically occur within the first 24hrs following administration. (See cautions above).
  • Monitor temperature, pulse, BP and respiration rate every 15 minutes throughout infusion and for 60 minutes post infusion
  • For severe hypersensitivity reactions: discontinue infusion immediately
    For mild/moderate reactions: Slow infusion to over 60mins or stop the infusion and allow reaction to resolve.  DO NOT disconnect.  After medical review the infusion may be restarted at a slower rate (suggest over 60mins).
  • Ensure hydrocortisone, chlorphenamine and paracetamol prescribed PRN in case of reaction. 

Sotrovimab is a black triangle drug.  All suspected adverse reaction must be reported via the COVID-19 Yellow Card reporting site or Yellow Card App.

 Interactions

No interaction studies have been performed.

Sotrovimab is not renally excreted nor is it metabolised by cytochrome P450 enzymes, therefore interaction with concomitant therapies that are renally excreted or that are substrates, inducers or inhibitors or CYP enzymes are unlikely.

Appendix 2: Proforma for national paediatric MDT for assessment of benefit of nMAB for adolescents aged 12-16yrs with recently diagnosed COVID-19 (symptoms and PCR or lateral flow test result < 7 days)
References

Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Early Treatment for Covid-19 with SARSCoV-2 Neutralizing Antibody Sotrovimab [published online ahead of print, 2021 Oct 27]. N Engl J Med. 2021

Editorial Information

Last reviewed: 03 March 2022

Next review: 31 March 2023

Author(s): Dr Conor Doherty; Dr Katherine Longbottom; Susan Kafka

Author Email(s): Conor.doherty@ggc.scot.nhs.uk

Approved By: Infectious Diseases Group