What is the maximum duration Mounjaro (tirzepatide) can be stored at room temperature?

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From the FDA Drug Label

If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86°F (30°C) for up to 21 days.

Mounjaro can be stored at room temperature for up to 21 days at a temperature not exceeding 86°F (30°C) 1.

From the Research

Mounjaro (tirzepatide) can be stored at room temperature for a maximum of 21 days, as indicated by the most recent and highest quality study available 2. After removing the pen from refrigeration, it should be kept at temperatures between 59°F to 86°F (15°C to 30°C) during this period. Once the 21-day room temperature limit is reached, the pen should be discarded even if medication remains inside, as the drug's stability and effectiveness cannot be guaranteed beyond this timeframe. Before this room temperature storage, Mounjaro should be kept refrigerated at 36°F to 46°F (2°C to 8°C) in its original packaging to protect it from light. This temperature sensitivity is due to tirzepatide being a peptide-based medication that can degrade when exposed to higher temperatures for extended periods. The 21-day room temperature allowance provides convenience for patients while ensuring the medication remains effective for its intended use in managing type 2 diabetes.

Some key points to consider:

  • The stability of medications at room temperature can vary significantly, and it's crucial to follow the specific guidelines for each medication, as seen in studies such as 3, 4, 5, and 6.
  • The study by 2 provides the most recent and comprehensive overview of allowable room temperature excursions for refrigerated medications, including those like Mounjaro.
  • Proper storage and handling of medications are critical to maintaining their efficacy and ensuring patient safety.
  • Always check the prescribing information and consult with a healthcare professional if there are any questions or concerns about the storage or use of Mounjaro or any other medication.

References

Research

Allowable room temperature excursions for refrigerated medications: A 20-year review.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2022

Research

Room-temperature storage of medications labeled for refrigeration.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2007

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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