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.
There 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
Original packs are labelled with an expiry date 2 years from manufacture; however, the Conditional Marketing Authorisation assigns only a 1 year shelf life. In addition, Batch Specific Variations dated January 2022 extend the shelf life to 18 months post-manufacture. Expiry dates may therefore need to be amended, both on receipt and while in stock in Trusts. Please refer to details in Handling casirivimab and imdevimab within Trusts.
The expiry date should be amended on the carton only: relabelling of the vials is not advocated as this would involve breaking the seal on the pack.
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
Vial labels for 1332mg vial
- Page updated following DHPC communication further extending expiry of both 300mg (2.5ml) and 1.2g (11.1mL) vial size presentations
- Updated to include details on new MHRA guidance that 300mg (2.5ml) size cartons may now have expiry reduction of 11 months