Scope
Our guidance covers receipt, storage and preparation of casirivimab and imdevimab using “pandemic packs”. Use of “pandemic packs” will be revised when alternative starting materials are available. We do not cover commissioning and eligibility; further advice is available in the CAS alert and subsequent CAS alert regarding use in hospitalised patients.
Expiry Changes January 2022
In January 2022, the MHRA gave permission for further shelf life extension for certain batches of both the 300mg (2.5ml) cartons and the 1332mg (11.1mL) cartons. SPS resources are currently being updated to reflect this change.
Chief Pharmacist responsibilities
Chief Pharmacist responsibilities for nMABs overall are covered in COVID-19 neutralising monoclonal antibodies and SPS support.
With specific reference to casirivimab and imdevimab they have responsibilities in the following domains.
Preparation location
Selection of the optimal preparation location, with aseptic preparation always being preferred for the following reasons:
- the preparation of this infusion is complex and has been assessed to be a NPSA High risk preparation
- withdrawals are required from 2 to 8 vials of two different starting materials, depending on the vial size, to prepare one infusion
- presenting a significant risk of microbial contamination and error
Systems
Setting up systems for:
- receipt of the starting materials and amending the incorrect expiry date
- timely preparation and issue of infusions
Preparation
Oversight of, and support to, preparation in clinical areas, where clinical area preparation is unavoidable.
Incident response
Ongoing review and responding to incidents and other problems.
Change history
- PDF version on institutional readiness document removed as all information now contained within web pages
- Removed reference to protecting the prepared infusion from light, as this is not required.
- Institutional readiness doc updated to include reference to use of separate kit for consumables due to incompatibility of some consumables with refrigerated storage. Additional information included on batch number format.
- Published