Perjeta with Solutions for Dilution
This article responds to your request for information on Perjeta® (pertuzumab) and compatibility with solutions for dilution.
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.
Last updated December 04, 2023
Abbreviations
NaCl=sodium chloride
PES=polyethersulfone
PO=polyolefin
PVC=polyvinyl chloride
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.[2] The study demonstrated that 0.45% NaCl could be used as an alternative diluent for the preparation of Perjeta.
Precaution again using dextrose 5% solution
Roche does not recommend 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.
References
- Roche Internal Regulatory Report. Accessed 12 July 2023.
- Roche Internal Technical Report. Accessed 12 July 2023.
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