Legal status
The initial stocks of sotrovimab 500mg made available in England during December 2021 were “emergency packs” supplied under a Batch Specific Variation. These have now since expired, and all currently available stock is now GB licensed Xevudy® 500mg in 8mL.
Receipt and storage
Sotrovimab must be stored in the original container at 2-8°C and protected from light.
Preparation
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 8mL sotrovimab 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.
Shelf life
Infusions made in a pharmacy Aseptic units are to be stored at 2-8°C 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.
Supporting materials
Update history
- Removed details of BSV 'emergency packs' as expired and GB licenced stock now in use
- Content reviewed and accurate
- glucose 5% added as potential diluent option
- Published