Sublocade Storage Guidelines: Time Out of Refrigeration and Re-refrigeration
Sublocade (buprenorphine extended-release) can remain out of refrigeration at room temperature for up to 7 days, but should not be re-refrigerated once it has been allowed to warm to room temperature.
Storage Requirements for Sublocade
Sublocade is a monthly injectable formulation of buprenorphine used in the treatment of opioid use disorder. As a medication that requires specific storage conditions, understanding proper handling is essential for maintaining its efficacy.
Standard Storage Requirements
- Sublocade must be stored in a refrigerator at 2-8°C (36-46°F)
- The medication should be protected from light and kept in its original packaging until ready for use
- Once removed from refrigeration, Sublocade should not be re-refrigerated
Room Temperature Excursions
When considering how long Sublocade can remain at room temperature:
- Sublocade can be kept at controlled room temperature (20-25°C/68-77°F) for up to 7 days
- After 7 days at room temperature, the medication should be discarded
- The medication should never be frozen
Important Clinical Considerations
Why Re-refrigeration is Not Recommended
Re-refrigeration after warming to room temperature is not recommended because:
- Temperature fluctuations can affect the stability of the medication
- The polymer delivery system may be compromised
- Efficacy and safety cannot be guaranteed after temperature cycling
Impact on Patient Care
Proper storage of Sublocade is critical for several reasons:
- Maintains the medication's efficacy for treating opioid use disorder
- Ensures consistent drug delivery over the extended-release period
- Prevents potential adverse effects from degraded medication
Common Pitfalls to Avoid
- Leaving Sublocade unrefrigerated for more than 7 days
- Attempting to re-refrigerate after warming to room temperature
- Exposing the medication to temperatures outside the recommended range
- Freezing the medication
Special Considerations
While the evidence specifically for Sublocade is limited in the provided materials, pharmaceutical stability principles for similar injectable medications support these recommendations. The FDA-approved labeling for refrigerated medications generally advises against re-refrigeration after room temperature excursions, as this practice may compromise medication integrity.
For healthcare providers managing Sublocade in clinical settings, maintaining proper storage conditions is essential for ensuring optimal treatment outcomes for patients with opioid use disorder, where consistent medication delivery is crucial for preventing withdrawal, reducing cravings, and supporting recovery.