Perjeta Storage, Preparation and Administration Recommendations

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

 

Please refer to the locally approved storage information provided in the Perjeta package insert or prescribing information. 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.                       

 

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Last updated August 15, 2023

Abbreviations

NaCl=sodium chloride                                                                                     

PES=polyethersulfone                                                                  

 PO=polyolefin

PVC=polyvinyl chloride  

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.

Preparing Perjeta for IV infusion

Recommendation for dilution with 0.9% NaCl solution

Perjeta should be diluted into a 250 mL PVC or non-PVC PO 0.9% NaCl infusion bag.[1] Do not withdraw any of the NaCl solution prior to adding Perjeta.

If diluting with 0.45% NaCl solution

Perjeta is not approved to be diluted with 0.45% NaCl. Any decision to use Perjeta that has been diluted with 0.45% NaCl would be off-label and a clinical decision to be made by the physician after an analysis of the benefit-risk ratio.

0.45% NaCl stability study

A study was conducted to assess the physicochemical stability of Perjeta after diluting it into non-PVC PO infusion bags containing 250 mL 0.45% NaCl solution and storing it for 24 hours at 2°C to 8°C or 24 hours at 30°C.[3] The study demonstrated that 0.45% NaCl could be used as an alternative diluent for the preparation of Perjeta. Please note,

Precaution again using dextrose 5% solution

Roche recommends against reconstituting or diluting with dextrose (or glucose) 5% solution.[1] Formulations of Perjeta diluted in Dextrose 5% solution infusion bags did not maintain a stable pH after storage for 24 hours at 27°C to 33°C, followed by 24 hours at 2°C to 8°C.

Compatibility of in-line filters

While in-line filters are not required for use, Perjeta has demonstrated compatibility with the following in-line filters

  • 0.2 µm PES in-line filter
    • 15 µm Nylon in-filter, and
      • 200 µm polyamide in-line filter.[4]
          

        No data are available for the use of cellulose in-line filters with Perjeta.[5]

        Filter compatibility study

        Compatibility of in-line filters were evaluated using an infusion solution of 420 mg of Perjeta, diluted to approximately 1.5 mg/mL in 0.9% NaCl.[4]

        References

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

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