For anyone prescribed semaglutide, knowing the exact storage and shelf-life guidelines is critical for ensuring the medication's safety and efficacy. Injectable semaglutide is a delicate, protein-based medication that can degrade over time and when exposed to improper conditions. While the manufacturer's expiration date on the box indicates its longevity when unopened and properly refrigerated, the 'beyond-use date' (BUD), or the period after the pen or vial is first opened, is what most patients need to track carefully.
The 28-Day Rule Explained: By Product Type
The '28-day rule' is a guideline, but it does not apply universally to all semaglutide products. Your specific medication, whether Ozempic, Wegovy, or a compounded version, has its own distinct timeline and storage requirements.
Ozempic (Multi-Dose Pen)
Ozempic pens contain multiple doses, which is why their after-opening shelf life differs. Once you use your Ozempic pen for the first time, it is safe to use for up to 56 days, or 8 weeks, as long as it is stored correctly. During this period, it can be kept either in the refrigerator or at room temperature (59°F–86°F or 15°C–30°C). After 56 days, any remaining medication must be discarded.
Wegovy (Single-Dose Pen)
Wegovy pens are pre-filled and contain only a single dose. An unopened Wegovy pen can be kept out of the refrigerator at room temperature (46°F–86°F or 8°C–30°C) for up to 28 days. Since it is a single-use injector, once the dose is administered, the pen is discarded. If you have an unopened pen that has been at room temperature for more than 28 days, it must be thrown away.
Compounded Semaglutide (Multi-Dose Vials)
Compounded versions of semaglutide are custom-made by licensed pharmacies and are not FDA-approved. As a result, their storage instructions and beyond-use dates (BUD) can vary. Many compounding pharmacies set a BUD of 28 days after the vial is opened, requiring refrigeration during that time. It is essential to follow the specific instructions provided by the compounding pharmacy and consult with your healthcare provider if you have any questions.
Oral Semaglutide (Rybelsus)
Rybelsus, the oral tablet form of semaglutide, does not require refrigeration and should be stored at room temperature (68°F–77°F or 20°C–25°C) in a dry place. It is not subject to the same strict post-opening timeline as injectable versions and can be used until the expiration date printed on the bottle.
Why Semaglutide Has a Limited Shelf Life
The need for strict timelines and storage conditions stems from the drug's nature. Semaglutide is a biologic drug, a medication derived from living organisms, specifically a peptide.
- Protein Instability: As a protein-based medication, semaglutide is fragile and susceptible to physical degradation, particularly when exposed to light, heat, or freezing. Exposure to these elements can cause the active protein molecules to break down or clump together (aggregate). This aggregation reduces the amount of active medication available in each dose, diminishing its effectiveness.
- Risk of Contamination: Once a multi-dose pen or vial is opened, it is no longer a sterile, closed system. Each time it's used, there is a small risk of introducing bacteria. Over time, these introduced bacteria could multiply, and injecting a contaminated substance could lead to serious infections. Preservatives in the solution help, but they are not effective indefinitely.
The Risks of Using Expired or Improperly Stored Semaglutide
Ignoring the expiration or beyond-use date is never advisable. The potential consequences far outweigh the temptation to use a seemingly good but expired dose.
- Reduced Clinical Effectiveness: The most immediate risk is that the medication will no longer provide the expected therapeutic benefits. For a patient managing diabetes, this could lead to poor blood sugar control. For someone using it for weight management, it could reduce feelings of fullness and curb food cravings less effectively, hindering progress.
- Unknown Side Effects: After the expiration date, the chemical composition of the drug is no longer guaranteed. Degradation could create new, potentially harmful breakdown products that could cause unexpected side effects or adverse reactions.
- Infection Risk: Injecting a potentially contaminated solution from a pen or vial that has passed its BUD can increase the risk of developing a serious local or systemic infection.
How to Properly Store and Handle Semaglutide
Following manufacturer guidelines is the best way to protect your medication's integrity. These rules ensure that the drug you are taking is both safe and effective.
- Refrigerate Until First Use: All unopened injectable semaglutide products (Ozempic, Wegovy) must be stored in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Mind the Temperature: Never freeze semaglutide. If it is frozen, it must be discarded immediately. Additionally, avoid leaving your pen in direct sunlight or in a hot car, as high temperatures can rapidly degrade the medication.
- Keep it in the Dark: Store your semaglutide pen or vial in its original carton to protect it from light.
- Track the Date: When you first open a multi-dose pen, write the date on it to track the 56-day (Ozempic) or 28-day (compounded) window.
- Visual Inspection: Before each injection, visually check the liquid in the pen or vial. It should be clear and colorless. If it looks cloudy, discolored, or contains particles, do not use it and discard it properly.
Comparison of Semaglutide Product Storage Guidelines
| Product | Type | Unopened Storage | After Opening/First Use | Time Limit After First Use | Room Temperature Limit Before First Use |
|---|---|---|---|---|---|
| Ozempic | Multi-Dose Pen | Refrigerated until expiration date | Refrigerated OR room temperature (up to 86°F) | 56 days | N/A (Keep refrigerated) |
| Wegovy | Single-Dose Pen | Refrigerated until expiration date | N/A (Single-use, discard after use) | N/A | Up to 28 days (if kept out of fridge, up to 86°F) |
| Compounded | Multi-Dose Vial | Check pharmacy's BUD and instructions | Refrigerated | Typically 28 days (check specific label) | Varies (check specific instructions) |
| Rybelsus | Oral Tablet | N/A (Not refrigerated) | N/A (Oral tablet) | Until expiration date on bottle | Up to expiration date |
Safe Disposal of Expired Semaglutide
For any injectable semaglutide product, including expired pens, safe disposal is a must. Used or expired needles and pens should be placed in an FDA-cleared sharps disposal container or another sturdy, puncture-proof plastic container with a tight-fitting, leak-resistant lid. Never put them in the regular trash. Many pharmacies offer take-back programs, or you can check local community guidelines for proper disposal. For expired oral tablets (Rybelsus), follow local regulations or use a drug take-back program.
Conclusion
The idea that all semaglutide expires after exactly 28 days is a simplification of product-specific guidelines. While this timeframe applies to some products and storage scenarios, it is not a universal rule. The actual beyond-use date and stability of your medication are dictated by the product type and proper storage conditions. Adhering to the manufacturer's directions for your specific prescription is essential to maintain the drug's safety and full therapeutic effect. If you ever have doubts about the viability of your semaglutide, the safest course of action is to dispose of it properly and consult your pharmacist or healthcare provider for a fresh supply. Following this cautious approach ensures your treatment plan stays on track and effective. More information on safe drug handling can be found on the FDA website.
