Perjeta Storage Recommendations

This article responds to your request for information on Perjeta® (pertuzumab) and storage recommendations.

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Last updated December 04, 2023

Storing the unopened vial

Perjeta vials should be stored at 2°C to 8°C.[1] The vial should be kept in the outer carton in order to protect from light.

If Perjeta was inadvertently stored outside of this temperature range, a stability assessment can be requested through medinfo.roche.com.

Storing the infusion bag containing the diluted solution

Temperature

The diluted solution of Perjeta is physically and chemically stable for up to 30 days at 2°C to 8°C and 24 hours at room temperature (≤30°C).[1]

From a microbiological point of view, the Perjeta infusion solution should be used immediately.[1] If not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Light

In the study that assessed the physicochemical stability of the diluted solution of Perjeta for up to 30 days at 2°C to 8°C and 24 hours at ≤30°C, the infusion bags containing the diluted drug product were protected from light.[2] Please refer to your local Perjeta prescribing information or package insert for locally approved light storage recommendations.

References

  1. Roche Internal Regulatory Report. Accessed 12 July 2023.
    1. Roche Internal Technical Report. Accessed 12 July 2023.

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