Legal status of pandemic packs
Casirivimab and Imdevimab (Ronapreve®) has a conditional Marketing Authorisation (CMA). The first packs supplied will be unbranded “pandemic” packs supplied under a Batch Specific Variation to the CMA, so are licensed in GB.
A national distribution service will deliver the centrally allocated casirivimab and imdevimab packs to Trusts. Trusts will provide infusion bags and consumables from existing stock.
Their are two version of the pandemic packs for which the BSV applies (see artwork below). The cartons contain either:
- one vial of casirivimab 300mg in 2.5mL and one vial of imdevimab 300mg in 2.5mL; or
- one vial of casirivimab 1332mg in 11.1mL and one vial of imdevimab 1332mg in 11.1mL
Packs are unbranded and without MA number
- are unbranded, and are not labelled as “Ronapreve”
- are not labelled with a Marketing Authorisation number.
Pack label and vial expiry dates may need to be changed
Large volume vials
The larger volume presentation (1332mg & 1332mg) will have:
- the outer carton overlabelled with the correct expiry date
- the inner vials will be labelled with the wrong expiry dates
Relabelling of the vials is not advocated as this would involve breaking the seal on the pack.
Small volume vials
The smaller volume presentation (300mg & 300mg) will have:
- the wrong expiry on both the outer carton and the vials
- these will need to be overlabelled with a new expiry date on receipt
Packs are labelled with an expiry date 2 years from manufacture; however, the CMA assigns only a 1 year shelf life. This means that a new expiry date will need to be given, as per the process described in Handling casirivimab and imdevimab within Trusts.
Pack strength and quantity labelling may be misleading
The pandemic packs for which the BSVs apply are:
One vial of casirivimab 300mg in 2.5mL and one vial of imdevimab 300mg in 2.5mL
The packs are labelled “Casirivimab and Imdevimab 120mg/mL” “2 vials of 6mL”. However, each carton contains two vials:
- one vial contains casirivimab 300mg in 2.5mL (120mg/mL)
- the other contains imdevimab 300mg in 2.5mL (120mg/mL)
Note that although the nominal volume of each vial is 2.5mL, the actual fill volume for each of the vials is expected to be greater.
One vial of casirivimab 1332mg in 11.1mL and one vial of imdevimab 1332mg in 11.1mL
The packs are labelled “Casirivimab and Imdevimab 120mg/mL” “2 vials of 20mL”. However, each carton contains two vials:
- one vial contains casirivimab 1332mg in 11.1mL (120mg/mL)
- the other contains imdevimab 1332mg in 11.1mL (120mg/mL)
Packs are supplied with a DHPC letter
Packs are supplied individually (cartons of 2 vials) in a bag with a copy of a Dear Healthcare Professional Communication (DHPC) from Roche a copy of the GB licensed PIL.
Note that although the DHPC letter and PIL make reference to the licensed dose and indication for Ronapreve, this detail is not relevant to the off-label use of 2.4g doses described in the CAS alert.
Carton labels for 300mg vial
Carton labels for 1332mg vial
Vial labels for 300mg vial