Quarantine bags

• Quarantine individual bags in a refrigerator on receipt.
• Cartons are individually bagged with copy of DHPC letter and PIL so will require relatively large storage space in short term.
• Some stock may need its expiry date to be amended (see below)
• The DHPC letter 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.

Background to amending expiry dates in 2021

The MHRA required the first stocks of Ronapreve (casirivimab and imdevimab) to have their labelled expiry dates reduced by 1 year. 300mg cartons were amended by Trusts on receipt; 1332mg cartons were received with their expiry dates already reduced by the manufacturer.

On 07/12/2021 the MHRA gave permission for an expiry reduction of the 300mg cartons of only 11 months. This meant that existing Trust stocks of 300mg cartons that had already been overlabelled had their expiry dates extended by one month to end January 2022

Assigning new expiry dates in 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.

Whether newly received, or existing stock, all the following batches can be assigned new expiry dates for 2022.  Use our overlabelling worksheets to help.

The stock you receive or have in stock may already have had their expiry dates reduced or extended. The following tables show the details:

Small volume vials 300mg (2.5ml)

Large volume vials 1332mg (11.1mL)

N.B. 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 worksheets below to help amend the expiry dates

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

Preparation for subcutaneous administration

• Preparation for subcutaneous injection involves direct withdrawals from vials into syringes. For further details, staff should refer to instructions in the product SPC on preparation and administration via the subcutaneous route (section 6.6). Example kit worksheets and clinical area preparation records are provided below.

Prepare product

The infusions required are

• a combined dose of 1200mg (600mg casirivimab and 600mg imdevimab) in 250mL sodium chloride 0.9%. This will require 5mL casirivimab 120mg/mL and 5mL imdevimab 120mg/mL to be added to one bag of 250mL sodium chloride 0.9%.
• a combined dose of 2400mg (1200mg casirivimab and 1200mg imdevimab) in 250mL sodium chloride 0.9%. This will require 10mL casirivimab 120mg/mL and 10mL imdevimab 120mg/mL to be added to one bag of 250mL sodium chloride 0.9%.

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.

Use of larger vials to make two bags

• When using the larger 11.1mL vials to prepare the 1200mg total dose (600mg casirivimab and 600mg imdevimab), 2 bags may be prepared at the same time.
• Trusts with existing systems in place to manage batch/campaign preparation may utilise these to control the preparation process
• For Trusts without existing systems, an SPS example worksheet has been provided with a suggested vial sharing method for preparation under section 10 exemption.
• The method involves the preparation of 2 bags labelled for stock and quarantining them within the aseptic unit. Each bag must then be dispensed against a named-patient prescription with a patient-specific label prior to issue to a clinical area

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, the optional step of combing the required vials with a clinical area preparation record to create a kit may be considered.
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. These resources are designed for use by staff who already have basic competency in the preparation of injectable medicines.

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 infusions required are

• a combined dose of 1200mg (600mg casirivimab and 600mg imdevimab) in 250mL sodium chloride 0.9%. This will require 5mL casirivimab 120mg/mL and 5mL imdevimab 120mg/mL to be added to one bag of 250mL sodium chloride 0.9%.
• a combined dose of 2400mg (1200mg casirivimab and 1200mg imdevimab) in 250mL sodium chloride 0.9%. This will require 10mL casirivimab 120mg/mL and 10mL imdevimab 120mg/mL to be added to one bag of 250mL sodium chloride 0.9%.

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.
• When preparing a combined dose of 1200mg (600mg casirivimab and 600mg imdevimab) using the larger 11.1mL vials, a significant volume of the solution will remain in the vials following withdrawal of the required 5mL. Unless prepared in a pharmacy aseptic unit, the remaining excess solution in the vials must be discarded immediately and must not be retained to prepare additional bags.

Shelf life of infusions

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