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 November 12, 2024
Abbreviations
NaCl=sodium chloride
PES=polyethersulfone
PE=polyethylene
PO=polyolefin
PVC=polyvinyl chloride
PP=polypropylene
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 yet. 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 when diluted in 250 ml 0.45% NaCl solution. Both 420 mg maintenance and 840 mg loading doses were evaluated [2].
- Results demonstrated that Perjeta was physicochemically compatible with 0.45% NaCl when stored for up to 24 hours at 30°C and up to 30 days at 2-8°C, protected from light.
- These study results apply to polyolefin-polyethylene-polypropylene (PO-PE-PP) and polyvinyl chloride (PVC) bags.
- Perjeta does not contain a preservative and microbial stability after dilution with 0.45% NaCl was not tested.
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 04 Sep 2024.
- Roche Internal Technical Report. Accessed 04 Sep 2024..
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