What is the shelf life of Lantus (insulin glargine) Solostar at room temperature?

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From the Guidelines

Lantus (insulin glargine) SoloStar pens can be kept at room temperature (below 86°F or 30°C) for up to 28 days after first use. This guideline is based on the most recent expert recommendations, as outlined in the Mayo Clinic Proceedings 1. Before opening, it is advised to store Lantus SoloStar in the refrigerator between 36°F to 46°F (2°C to 8°C). However, once a pen is in use, it should not be returned to the refrigerator. The 28-day limit at room temperature applies regardless of the amount of insulin remaining in the pen.

After this period, the insulin may start to degrade, potentially becoming less effective at controlling blood glucose levels due to the breakdown of insulin proteins when exposed to warmer temperatures for extended periods. It is crucial to discard the pen after 28 days from first use, even if there is insulin remaining, to ensure the medication maintains its full potency and effectiveness for managing diabetes. Always check the insulin for expiration and cloudiness before injection, following the guidelines for handling cloudy insulin as necessary.

Key points to consider:

  • Store unopened Lantus SoloStar pens in the refrigerator at 2 to 8 °C (36 to 46 °F) 1.
  • Once opened, store at ambient temperatures (15 to 30 °C or 59 to 86 °F) away from direct sunlight.
  • Do not remove insulin from a prefilled disposable insulin pen using a syringe unless absolutely necessary.
  • Discard the pen after 28 days from first use, regardless of the remaining insulin, to maintain effectiveness.

From the Research

Shelf Life of Lantus Solostar at Room Temperature

  • The shelf life of Lantus (insulin glargine) Solostar at room temperature is not directly stated in the provided studies.
  • However, a study on the thermal stability and storage of human insulin 2 suggests that unopened vials and cartridges can be stored at up to 25 °C for a maximum of six months and at up to 37 °C for a maximum of two months without a clinically relevant loss of insulin potency.
  • For opened vials and cartridges, the study found no clinically relevant reduction in insulin activity at up to 37 °C for up to 12 weeks.
  • It is essential to note that the study focused on human insulin in general, not specifically on Lantus Solostar.
  • Another study on the dose accuracy and injection force dynamics of a novel disposable insulin pen 3 mentions SoloStar, the device used for Lantus Solostar, but does not provide information on its shelf life at room temperature.
  • Studies on the comparison of long-acting insulin analogues, including Lantus, to NPH insulin 4, 5 do not address the shelf life of Lantus Solostar at room temperature.
  • A study on dosing accuracy with the SoloSTAR device 6 also does not provide information on the shelf life of Lantus Solostar at room temperature.

Storage Conditions

  • The studies suggest that insulin should be stored at a temperature between 2 °C and 8 °C to maintain its potency.
  • However, in situations where refrigeration is not available, insulin can be stored at room temperature (up to 25 °C) for a shorter period, typically up to 28 days.
  • It is crucial to follow the manufacturer's instructions for storage and handling of Lantus Solostar to ensure its effectiveness and safety.

References

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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