Quarantine bags

• Quarantine individual bags in a refrigerator on receipt.
• Cartons are individually bagged with copy of DHPC and PIL so will require relatively large storage space in short term.
• Stock must be quarantined until the new expiry date can be added (300mg cartons).
• The DHPC must be removed from both vial sizes as this is not relevant to the use described in the Commissioning Policy.

Use our guide

Use our quick reference guide below to help.

Over label cartons

Small volume vials 300mg

Over label 300mg cartons with the new expiry date as soon as practicable under the supervision of a pharmacist. Expiry dates must be amended in the Pharmacy Department under the supervision of a pharmacist. Expiry dates should be amended by batch number as follows:

Large volume vials 1332mg

The large volume vials will arrive with the carton over labelled already:

The first 5 characters of the batch number are the same as the batch number of the casirivimab vial inside the carton. e.g N7561B01. The batch numbers printed on the carton contain an extension which is the batch number of the imdevimab vial inside the carton e.g. N7561B01 N7560.

Minimise time at room temperature

Minimise the time the product spends at room temperature during over labelling.

Refer to our article for background

See our article on pandemic packs for background on why amending the expiry date is necessary.

Use our over labelling worksheet

Use our over labelling worksheet below to help.

Pharmacy aseptic preparation is preferred

The best option is to seek to prepare the product in a pharmacy aseptic unit following normal Good Manufacturing Practice.

Preparation in clinical areas should be governed

If preparation in a pharmacy aseptic unit is not practicable, Chief Pharmacists should ensure that preparation in clinical areas is:

• undertaken by suitably trained and skilled staff, working to locally approved methods
• documented with records maintained
• supported by casirivimab and imdevimab being packed, together with a preparation record for clinical staff (and consumables, if necessary) into a kit for supply to the area

Prepare product

The infusion requires 10mL Casirivimab 120mg/mL and 10mL Imdevimab 120mg/mL to be added to one 250mL bag of sodium chloride 0.9% (total dose 2.4g: 1200mg casirivimab and 1200mg imdevimab in 270mL total volume).

Large volume vials

There is overage in each vial to facilitate withdrawal of the full dose.

Small volume vials

There may be significant overage in each vial:

• If the first three vials are emptied almost completely, there may be considerable residual volume left in the fourth vial.
• This must be discarded.

Supply product to clinical area

Supply the completed infusion to the clinical area once prepared. The infusions should be protected from vibration and excessive movement during storage and transport to the clinical area. The bags must not be shaken.

Preparation notes

• Depending on the amount of overage and the volume that can be removed from each vial, up to 4 vials of casirivimab 300mg and 4 vials of imdevimab 300mg (4 cartons) will be required.
• SPS recommends that the casirivimab and imdevimab solutions are added to the 250mL 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. As the infusions will take longer than 20 minutes to prepare there is no need to allow the vials to stand before beginning preparation.
• Un-used vials may be able to be saved and used for subsequent products provided that the tamper evident cap is still in place.

Shelf life of infusions

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.

Create a kit in pharmacy

If ward preparation is unavoidable, appropriate cartons may be combined with a clinical area preparation record to create a kit.
Consumables required for preparation may be (if required) packed as a separate kit for supply to the clinical area, and stored at room temperature.
Example kit worksheets and clinical area preparation record are provided below.

Provide kits on request

It is recommended that kits are provided on request rather than being stored in clinical areas.
Pharmacy departments will need to ensure that clinical areas are supported to safely prepare the infusions.

Preparation notes

The infusion requires 10mL casirivimab 120mg/mL and 10mL imdevimab 120mg/mL to be added to one 250mL bag of sodium chloride 0.9% (total dose 2.4g: 1200mg casirivimab and 1200mg imdevimab in 270mL total volume):

• Depending on the amount of overage and the volume that can be removed from each vial, up to 4 vials of casirivimab 300mg and 4 vials of imdevimab 300mg (4 cartons) will be required.
• SPS recommends that the casirivimab and imdevimab solutions are added to the 250mL 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. As the infusions will take longer than 20 minutes to prepare there is no need to allow the vials to stand before beginning preparation.
• Un-used vials may be able to be saved and used for subsequent products provided that the tamper evident cap is still in place.

Shelf life of infusions

If the infusion is prepared in a clinical area it should be used immediately.