Does Brixadi Need Refrigerated?: Answering Storage Questions

Unlike some other injectable treatments for opioid use disorder, Brixadi (buprenorphine) does not need to be refrigerated and should be stored at controlled room temperature. Understanding the correct storage requirements is vital to ensuring the medication's stability and effectiveness for treating moderate to severe opioid use disorder.

Quick Summary

Brixadi (buprenorphine) is a subcutaneous injection that should be stored at controlled room temperature, not refrigerated. Correct storage is essential for maintaining its potency and therapeutic effects. The pre-filled syringe must be kept within the specified temperature range to prevent compromise of the medication's composition.

Key Points

• Room Temperature Storage: Brixadi does not need to be refrigerated and should be stored at a controlled room temperature, typically 20-25°C (68-77°F).

• Temperature Excursions: Short temperature excursions up to 30°C (86°F) are permitted, but the medication should be protected from freezing and excessive heat.

• Professional Administration: Brixadi is administered by healthcare professionals in a clinical setting, so patients are not responsible for storing the medication at home.

• Controlled Substance: Due to its classification as a Schedule III controlled substance, Brixadi requires strict security and accountability in storage at healthcare facilities to prevent diversion.

• Distinction from Other Injections: The room temperature storage requirement for Brixadi is a key difference from other buprenorphine injections like Sublocade, which requires refrigeration.

• Medication Stability: Proper storage is crucial to ensure the medication remains stable and effective for treating opioid use disorder.

Proper Storage for Brixadi

Brixadi, an extended-release buprenorphine injection, is a crucial treatment for individuals with moderate to severe opioid use disorder. The storage instructions for this medication are clear and distinct from other long-acting buprenorphine products. The manufacturer specifies that Brixadi should be stored at controlled room temperature, not refrigerated. This is a key difference that impacts logistics for healthcare providers and how the medication is handled before administration.

Specifically, the storage temperature for Brixadi should be between 20°C and 25°C (68°F and 77°F), with short excursions permitted between 15°C and 30°C (59°F and 86°F). Exposing the medication to temperatures outside this range could affect its stability and potentially compromise its therapeutic effect. It is important to protect the product from freezing and excessive heat. As a controlled substance, proper storage also includes maintaining adequate security and accountability to prevent diversion.

Comparison of Storage Requirements for Buprenorphine Injections

When considering long-acting buprenorphine products, it's essential to understand their different storage needs. Below is a comparison of Brixadi and another common formulation, Sublocade.

Feature	Brixadi (buprenorphine)	Sublocade (buprenorphine)
Refrigeration Required?	No	Yes, must be refrigerated at 2°C to 8°C (36°F to 46°F)
Room Temperature Storage	Can be stored at controlled room temperature (20-25°C or 68-77°F) with permitted excursions (15-30°C or 59-86°F).	Can be kept at room temperature for a maximum of 7 days before administration; must be discarded if unused within this timeframe.
Patient Handling	Injections are administered by a healthcare provider in a clinical setting, so patients typically do not handle storage.	Injections are administered by a healthcare provider, and the specific handling protocols are defined by a restricted program (REMS).
Handling Logic	Simpler logistics for clinical settings as refrigeration is not needed.	Requires careful temperature monitoring, both in storage and after removal from refrigeration.

What Happens If Brixadi Is Improperly Stored?

Storing Brixadi outside the recommended temperature range can have serious consequences. For instance, freezing temperatures can damage the medication's composition, rendering it ineffective. High temperatures, such as those found in a car on a hot day, can also degrade the medication. Any such compromise in the product's integrity could mean the patient receives a sub-therapeutic dose, potentially leading to treatment failure. This emphasizes why healthcare providers follow strict protocols for handling and storing this controlled medication.

Administration and Handling Protocols

The administration of Brixadi is a multi-step process that must be conducted by a certified healthcare professional within a restricted program known as the BRIXADI REMS. The pre-filled syringe is administered as a subcutaneous injection into the buttock, thigh, abdomen, or upper arm. The professional administration model ensures proper handling, including correct storage, preparation, and disposal of the syringe, which is critical for a schedule III drug product. Patients do not take the medication home with them, which eliminates the risk of improper at-home storage and potential diversion.

Frequently Asked Questions

• Q: What is the purpose of a medication storage program like the BRIXADI REMS? A: The BRIXADI REMS program exists to mitigate the risk of serious harm or death from intravenous self-administration of the medication. By restricting the dispensing and administration to certified healthcare settings, it ensures proper handling, storage, and injection techniques are followed.
• Q: Can I store my Brixadi at home in a secure place? A: No, patients do not receive Brixadi for at-home storage or administration. The injection is administered by a healthcare professional in a clinical setting as part of the REMS program requirements.
• Q: How does Brixadi's storage compare to other injectable medications like insulin? A: Unlike Brixadi, many injectable medications, such as insulin and some biologics, must be refrigerated to maintain their efficacy. Patients or providers must verify the specific storage requirements for each medication, as they vary significantly.
• Q: What should I do if my clinic's Brixadi is accidentally stored in a refrigerator? A: If the medication is suspected of being stored improperly, it should be considered compromised. A pharmacist or the manufacturer's representative should be consulted to determine if it is still safe and effective for use.
• Q: What is the risk of a medication being exposed to temperature extremes? A: Both high and low temperatures can affect the chemical stability of a medication. This can lead to loss of potency, altered composition, or visible changes in consistency, potentially making the drug less effective or unsafe.
• Q: Is there a benefit to Brixadi not needing refrigeration? A: Yes, not requiring refrigeration simplifies the storage logistics for certified healthcare providers and pharmacies. It eliminates the need for strict cold-chain management and reduces the potential for temperature-related errors during transport and storage.
• Q: How long is Brixadi stable at the recommended storage temperature? A: Based on stability data, the expiry period for Brixadi can be up to 36 months when stored at the controlled room temperature specified by the manufacturer.

Conclusion

In summary, Brixadi stands out from some of its alternatives due to its flexible room-temperature storage requirements. Crucially, Brixadi does not need refrigerated storage, simplifying its handling for healthcare providers in certified settings. Adhering to the manufacturer's recommended controlled room temperature is essential for maintaining the medication's efficacy and stability. Given that it is administered exclusively by professionals within a regulated program (REMS), patient involvement in storage is not a concern, ensuring a high standard of safety and treatment fidelity. This unique storage profile represents a logistical advantage in the clinical management of opioid use disorder. All healthcare professionals involved must be fully trained and certified to handle this medication correctly to ensure patient safety and positive treatment outcomes.

Citations

[ { "title": "Braeburn's BRIXADI™ (buprenorphine) Extended-Release ...", "url": "https://braeburnrx.com/media/press-releases/braeburns-brixadi-buprenorphine-extended-release-subcutaneous-injection-ciii-receives-fda-approval-for-moderate-to-severe-opioid-use-disorder" }, { "title": "Brixadi®: 3 things to know about the buprenorphine treatment ...", "url": "https://www.genoahealthcare.com/about/blog/brixadi-3-things-to-know-about-the-buprenorphine-treatment-option.html" }, { "title": "BUPRENORPHINE INJECTIONS", "url": "https://atlmedarts.org/?page_id=1168" }, { "title": "INSTRUCTIONS FOR USE BOOKLET - Brixadi", "url": "https://www.brixadihcp.com/pdfs/instructions-for-use.pdf" }, { "title": "BRIXADI (buprenorphine) - accessdata.fda.gov", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210136Orig1s000ltr.pdf" }, { "title": "Buprenorphine | VCA Animal Hospitals", "url": "https://vcahospitals.com/know-your-pet/buprenorphine" }, { "title": "Keep Your Medications Away From Summer Heat! - Polk County", "url": "https://www.polkcountyiowa.gov/media/hf3ncrhe/medication-handout.pdf" }, { "title": "Medication Storage Temperature Guidelines - GoodRx", "url": "https://www.goodrx.com/drugs/medication-basics/medication-storage-temperature-guidelines" }, { "title": "Long-Acting Buprenorphine Products for OUD Tip Sheet", "url": "https://www.ihs.gov/sites/opioids/themes/responsive2017/display_objects/documents/labuprenorphinetipsheet.pdf" } ]

Frequently Asked Questions

Does Brixadi require refrigeration for storage?

No, Brixadi does not require refrigeration. It is designed to be stored at a controlled room temperature, typically between 20°C and 25°C (68°F and 77°F), with short excursions permitted up to 30°C (86°F).

Why is Brixadi's storage different from some other buprenorphine products?

Brixadi's unique formulation and technology allow for storage at room temperature. Other long-acting buprenorphine injections, like Sublocade, require refrigeration until a specific time before administration.

What happens if Brixadi is frozen?

If Brixadi is frozen, the medication’s chemical composition could be permanently altered, rendering it unsafe and ineffective. It should be discarded and not used if it has been exposed to freezing temperatures.

Is it safe to leave Brixadi in a hot car?

No, it is not safe to leave Brixadi in a hot car. High temperatures can degrade the medication, reducing its effectiveness and potentially making it unsafe for administration.

Who is responsible for storing Brixadi?

Because Brixadi is only administered by healthcare professionals in certified settings, the responsibility for storage lies with the clinic or pharmacy. Patients do not receive the medication to take home.

How should a pharmacy store Brixadi to ensure security?

As a controlled substance, pharmacies must store Brixadi with adequate security and accountability. This typically involves storing it in a locked cabinet or secure location, separate from non-controlled medications.

What should be done if Brixadi is exposed to temperatures outside the recommended range?

If Brixadi is exposed to temperatures outside the controlled room temperature range, it should be considered compromised. The medication should not be used, and a pharmacist or manufacturer should be contacted for guidance.