What is the refrigerated storage duration of pembrolizumab (Keytruda)?

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Last updated: April 9, 2025View editorial policy

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From the FDA Drug Label

Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. The diluted solution can be stored under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution.

The storage time for pembrolizumab in the fridge is up to 96 hours for the diluted solution and it should be stored at a temperature between 2°C to 8°C (36°F to 46°F). The undiluted vials should also be stored under refrigeration at the same temperature range 1.

From the Research

Pembrolizumab can be stored in a refrigerator at 2°C to 8°C for up to 6 weeks after dilution, as demonstrated by the most recent and highest quality study 2. When considering the storage of pembrolizumab, it's crucial to prioritize the most recent and reliable evidence to ensure the medication's efficacy and safety. The study published in 2024 2 provides the most up-to-date and high-quality data on the storage of pembrolizumab, indicating that it can be stored for up to 6 weeks after dilution when refrigerated at 2-8°C. This information supersedes previous guidelines and recommendations, offering a more extended storage period that can help minimize waste and optimize the use of this medication. Key points to consider when storing pembrolizumab include:

  • Storage in the original carton to protect from light
  • Refrigeration at 2°C to 8°C
  • Avoidance of freezing, as it can damage the protein structure of the monoclonal antibody
  • Protection from light during storage
  • Discarding any unused portion after the recommended storage period to prevent microbial contamination. It's essential to follow the guidelines provided by the most recent study 2 to ensure the safe and effective use of pembrolizumab.

References

Research

Prolonged in-use physicochemical and biological stability of nivolumab and pembrolizumab diluted in saline infusion bags and in partially used medication vials.

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2024

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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