From understanding why Tirzepatide, the biological drug in Zepbound, needs to be refrigerated to learning about its shelf life and the nuances of handling it while traveling, here come clear and helpful information!
Related article: Zepbound, A Complete Guide About the Newest Weight-Loss Drug.
What is Zepbound?Before we dive into our topic, let’s have a reminder about what Zepbound is exactly. This prescription drug is the newest weight-loss injection to have been approved by the FDA on November 8, 2023. It is approved for weight-loss purposes in adults with obesity and adults who are overweight and have related health complication, such as diabetes or hypertension for example.
It’s an injectable drug, self-administered via weekly subcutaneous injections, and available in 6 doses ((2,5 mg, 5 mg, 7,5 mg, 10 mg, 12,5 mg, and 15 mg).
Unlike other weight-loss injections like Wegovy or Saxenda, Zepbound is unique in its dual-action mechanism, targeting two crucial hormone receptors: GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1).
Its active ingredient, Tirzepatide, operates on a complex level. Without entering into too much detail regarding how Zepbound works in your body exactly (you can read about that here), here’s a simplified overview of what happens when you take Zepbound:
- It reduces your appetite and caloric intake.
- It slows down gastric emptying, making you feel full longer.
- It improves your metabolism.
- It improves blood sugar control.
- It reduces fat storage.
Tirzepatide is also the active drug found in Mounjaro, an injection for types 2 diabetes patients.
Tirzepatide, a fragile biological drugTirzepatide (Zepbound’s active ingredient) is a biological drug, meaning it’s developed from living organisms, such as cells and tissues. Biologics are often seen as the cutting-edge of biomedical research and known for their effectiveness in conditions where traditional drugs might fall short.
But while the biological nature of Zepbound is what makes it particularly efficient, it is also what makes it very fragile and sensitive to temperature fluctuations and light exposure. Indeed, biological drugs can degrade quickly if not stored properly, affecting their efficacy and safety.
Hence, the need to make sure you’re mastering Zepbound’s storage requirements before going home with your new injections. Always keep in mind that proper storage is not just a matter of prolonging Zepbound's shelf life; it’s a key to ensuring the medication retains its full therapeutic properties and is safe to use.
Related article: Does Mounjaro Need to be Refrigerated? How to Store your Injection Pens?
How to Store Zepbound Correctly?According to Eli Lilly, the manufacturer of Zepbound, here’s how you should store your Zepbound injection pens at home:
- Zepbound should be stored in the refrigerator between 2°C to 8°C (36°F to 46°F).
- Never freeze the medicine. If a pen has frozen, it’s not safe to use anymore, even if it has thawed afterwards.
- Always keep Zepbound pens in their original carton box, protected away from direct light.
- When refrigeration is not possible, Zepbound can be kept at room temperature (up to 30°C or 86°F) but for a maximum of 21 days only.
- Do not put Zepbound back in the fridge once it has reached room temperature, as such temperature fluctuations aren’t good for the medicine inside.
- Discard any injection pen that has been out of the fridge for more than 21 days.
Does Zepbound need to be refrigerated?Yes, according to the storage instructions above, Zepbound needs to be refrigerated. Biological drugs, including Tirzepatide found in Zepbound, are composed of proteins and other biological substances derived from living cells. These components are extremely sensitive to environmental conditions, especially temperature.
What happens if it’s not refrigerated?When Zepbound or similar biological drugs are not stored at the recommended temperature range, several detrimental changes can occur:
- Protein denaturation: Biologics are complex protein structures that maintain their function and efficacy through a specific three-dimensional shape. Exposure to warm temperatures can cause these proteins to unfold or denature, which can alter the drug's structure and render it ineffective.
- Aggregation: Improper storage temperatures can also lead to the aggregation of protein molecules. When proteins denature, they expose hydrophobic regions that tend to stick together, forming aggregates. These aggregates can not only reduce the effectiveness of the drug but also potentially trigger an immune response in the body.
- Degradation: Biological substances in Zepbound can chemically degrade over time if not kept at the correct temperature. The active substances in the drug can then degrade, diminishing its potency and therapeutic capabilities.
- Risk of contamination: While less of a concern with sealed injectable drugs like Zepbound, incorrect storage conditions can also compromise the sterility of the medication, leading to risks of bacterial contamination.
How long can it be out of the fridge?Fortunately, though, there is some flexibility when it comes to the short-term storage of Zepbound. When refrigeration isn’t possible, say because you’re traveling for example, Zepbound pens can be safely stored at room temperature for up to 21 days. But they should never be exposed to temperatures above 30°C (86°F).
Any Zepbound pen that has been out of the fridge for more than 21 days should be discarded. The medication's stability and effectiveness simply can no longer be guaranteed here.
Keeping your injections cool while travelingAnd that takes us to our next point: how to keep your Zepbound injections cool when traveling or away from home? Well, there are two different scenarios to think about here:
- You’re traveling for less than 21 days
So, if you’re traveling to places where the temperature may get higher than that, you must use a medical-grade travel cooler, like the ones from 4AllFamily for example.
- You’re traveling for more than 21 days
Recognizing Expired or Compromised ZepboundAs a safety rule, always inspect your injection pens before every injection, even if you’re sure it’s been properly stored. Here are some key signs to watch for that may indicate Zepbound has expired or become compromised:
- Color changes: Zepbound looks like a clear, water-like liquid. If you see any change in color do not use it. It could be a sign of degradation or contamination.
- Cloudiness: Zepbound should be clear, without any cloudiness. If the liquid in the pen appears cloudy or murky, it's a strong indication that it may have gone bad.
- Particles: If you observe any floating particles, sediment, or crystalline structures, it may not be safe to use either.
- Consistency: Any noticeable change in the thickness or thinness of the liquid could be a cause for concern too. For example, a thicker or gel-like consistency might suggest that the medication has been exposed to inappropriate temperatures or conditions.
- Container integrity: Inspect the pen itself for any signs of damage, leakage, or tampering. Do not use a pen if it looks broken or damaged.
Zepbound expiration dateLike all medications, Zepbound comes with an expiration date, which is clearly labeled both on the pen and the carton box in which it is packaged. This date is determined by the manufacturer and indicates the timeframe during which the product is expected to remain stable and effective, provided it is stored correctly.
Make it a routine to verify the expiration date as part of your pre-injection preparation. And never use expired medicine!
Related article: Does insulin expire? How long is it good for?
Disposal of Zepbound Injector PensZepbound injector pens are medical sharps and can pose risks of injury and contamination to others. They should never be thrown in the household trash!
Used pens should be placed in an FDA-cleared sharps disposal container. If you don’t have a sharps container, a heavy-duty plastic household container can be used as an alternative.