Vabysmo▼ Vial Storage and Handling Conditions
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
This letter responds to your request for information on the storage and handling conditions of Vabysmo® (faricimab-svoa) solution for intravitreal injection.
Please refer to the storage information provided in the manufacturers label. Any deviation from this information is considered off-label and any treatment decisions based on such deviations are the full responsibility of the prescribing physician.
Last updated September 12, 2023
Recommendation for Vabysmo vial storage conditions
Store the upopened vial at temperatures between 2°C to 8°C (36°F to 46°F). It should only be removed from the refrigerator in preparation for administration.[1]
Store the unopened vial in the original carton to protect it from light.[1]
Recommendation for Vabysmo vial handling conditions
Prior to use, allow the unopened vial of Vabysmo to reach room temperature (20°C to 25°C or 68°F to 77°F) for at least 5 minutes before proceeding with the administration. The unopened vial may be kept at room temperature for up to 24 hours.[2,3] Keep the vial in the original carton while acclimating to room temperature to protect it from light.[2]
Rationale of room temperature equilibrium
Allowing Vabysmo to reach room temperature reduces the viscosity of the solution. This is an important step for dosing accuracy as a less viscose solution allows the product to be drawn up and injected more easily.[4]
Tracking the 24-hour room temperature period
The unopened vial may be removed from the refrigerator (2°C to 8°C or 36°F to 46°F), kept at room temperature (20°C to 25°C or 68°F to 77°F) and then returned prior to use, as long as the total cumulative excursion time does not exceed a maximum of 24 hours.[5]
This means the vial may be exposed to several excursions. However, it is critical to ensure that all individual excursion durations are tracked because the 24-hour period is cumulative.[5]
References
- Data on file (Accessed on March 10 2023).
- Data on file (Accessed on March 21 2023).
- Data on file (Accessed on March 23 2023).
- Data on file (Accessed on March 23 2023).
- Data on file (Accessed on July 15 2022).
Medinfo
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