Extension to approved shelf-life for casirivimab + imdevimab (RONAPREVE)

The Therapeutic Goods Administration (TGA) has received and assessed additional stability data submitted by Roche Products Pty Ltd for their COVID-19 treatment, casirivimab and imdevimab (RONAPREVE).

At the time of initial provisional registration for RONAPREVE, the shelf-life was 12 months when stored at 2°C to 8°C. The TGA has now approved an application from the sponsor for an extension of shelf-life to 18 months when stored at 2°C to 8°C.

The extended shelf-life applies to RONAPREVE available as 120 mg/mL solutions for infusion or injection in 300 mg single dose vials (AUST R 373839) and in 1332 mg multi-dose vials (AUST R 374310).

Due to the use of an international label, the expiry date printed on the label for RONAPREVE (24 months) does not reflect the TGA-approved shelf-life (18 months). Healthcare professionals should be aware of the TGA-approved shelf-life, and ensure that the products are used within the approved shelf-life (no later than 6 months prior to the printed expiry date on the international label).

An updated Dear Healthcare Professional Letter will be issued to inform end-users of the extended shelf-life (18 months).

The extended shelf-life applies to all batches of RONAPREVE supplied to Australia. Existing stock can be used no later than 6 months prior to the printed expiry date, provided that approved storage conditions between 2°C to 8°C have been maintained.