Sotrovimab has been granted a conditional marketing authorisation by the MHRA. The initial stocks of sotrovimab 500mg in 8mL are “emergency packs”, which are supplied under a Batch Specific Variation. The details of the batches covered by the BSV are as follows:
Batch 1: Batch Number 7N9H, Expiry Date 05/22 (Emergency Pack livery)
Batch 2: Batch Number ER7H, Expiry Date 10/22 (GB commercial approved livery)
Subsequent stock will be of GB licensed Xevudy® 500mg in 8mL.
A national distribution service will deliver the centrally allocated sotrovimab 500mg packs to Trusts. Trusts will provide infusion bags and consumables from existing stock.
- are unbranded,
- are not labelled with a Marketing Authorisation number.
- are dual labelled in English and French
- are bundled with a hardcopy GB Patient Information Leaflet
- contain a insert within each carton with a QR code to access an electronic version of the GB Patient Information Leaflet and SPC
Receipt and storage
Sotrovimab must be stored in the original container at 2-8OC and protected from light.
The infusion required is 500mg (8mL) of sotrovimab 62.5mg/mL added to a 50mL or 100mL bag of sodium chloride 0.9% or glucose 5%.
- SPS recommends that 8mLsotrovimab solution is added to the bag of Sodium Chloride 0.9% without removing an aliquot from the bag. This reduces the number of aseptic manipulations and reduced the likelihood of errors. All bags currently in use by the NHS have sufficient capacity to permit this addition.
- The SmPC refers to allowing the vials to reach room temperature before use. This is for reasons of patient comfort during administration. If the diluent bag used is at room temperature, there is no need to allow the vial to warm first.
Our worksheet and preparation record in the ‘Supporting Material’ section below may be used if required. These resources are designed for preparation using a 50mL size bag of Sodium Chloride 0.9%, but may be adapted locally if a 100mL size bag is to be used.
Infusions made in a pharmacy Aseptic units are to be stored at 2-8 ºC for no more than 24 hours. The SmPC alternatively permits room temperature storage at up to 25 °C for no more than 6 hours.
If the infusion is prepared in a clinical area it should be used immediately.
Transport of prepared infusions
The infusions should be protected from vibration and excessive movement during storage and transport to the clinical area. The bags must not be shaken.
- Content reviewed and accurate
- glucose 5% added as potential diluent option