From the Guidelines
Degludec insulin can safely remain outside the refrigerator for a few hours without losing potency or effectiveness, and it is completely fine to use after such a period. According to the most recent evidence, once a degludec pen is in use, it should be stored at room temperature (between 59-86°F or 15-30°C) for up to 30 days or according to the manufacturer’s recommendations and within expiration dates 1. This means that if your pen was left unrefrigerated for just a few hours, it does not need to be discarded. The stability of degludec insulin at room temperature is due to its unique formulation, which forms stable multi-hexamers after injection that slowly dissociate to provide the ultra-long duration of action.
When handling insulin, it is essential to avoid exposing it to direct heat, light, or excessive agitation, as these conditions can damage the insulin and reduce its effectiveness 1. Additionally, cold insulin can be more painful to inject, so allowing it to warm to room temperature before injection is recommended. The key consideration is to protect insulin from extreme temperatures and follow the manufacturer’s storage guidelines to maintain its potency and effectiveness.
Some key points to consider when storing and handling insulin include:
- Storing unopened insulin in a refrigerator to maintain its maximum shelf life until the expiration date
- Avoiding extreme temperatures (<36 or >86°F, <2 or >30°C) and excess agitation
- Keeping insulin in use at room temperature to limit local irritation at the injection site
- Following the manufacturer’s storage guidelines and expiration dates to ensure the insulin remains effective.
From the FDA Drug Label
Pen in use: • Store the Pen you are currently using in the refrigerator between 36°F to 46°F (2°C to 8°C) or keep at room temperature up to 86°F (30°C). The FDA drug label does not directly answer what happens if Degludec (Insulin Degludec) is not refrigerated for a few hours, but it does provide storage instructions. Storage at room temperature is allowed for the pen in use, up to 86°F (30°C). However, no conclusion can be drawn about the specific effects of not refrigerating the pen for a few hours, as this information is not explicitly provided in the label 2.
From the Research
Storage Conditions of Insulin Degludec
- Insulin degludec is a long-acting basal insulin analogue with a predictable pharmacokinetic/pharmacodynamic profile 3
- The storage conditions of insulin can impact its blood glucose-lowering effect, and temperatures outside the recommended range can affect its quality 4
- There is no direct information on what happens if Degludec (Insulin Degludec) is not refrigerated for a few hours, but it is known that insulin storage conditions can have an impact on its effectiveness 4
Temperature Range for Insulin Storage
- The recommended temperature range for insulin storage is typically between 2°C and 8°C 4
- A study found that insulin was exposed to temperatures outside the recommended range for a clinically relevant percentage of storage time, especially when refrigerated 4
- However, the study did not specifically investigate the effects of short-term temperature deviations on insulin degludec 4
Practical Issues Related to Insulin Degludec Use
- Insulin degludec provides uniform action that extends over more than 24 hours and is highly consistent from dose to dose 5
- It is expected to simplify dose adjustment and enable patients to reach their glycemic targets with reduced risk of hypoglycemia 5
- However, the effects of short-term storage at room temperature on the efficacy and safety of insulin degludec are not explicitly stated in the available studies 3, 6, 5, 7