One of my staff left out an undiluted bottle of Botox in the room, and it was not refrigerated for about 3 days. Is it still effective?
Unrefrigerated Undiluted Botox
Doctor Answers (12)
BOTOX® is exceptionally stable
BOTOX® [in particular before reconstitution] is exceptionally stable, whether refrigerated at 4C or kept at room temperature ~25C.
A couple of friends who are leaders in the BOTOX® world proved this by taking a vial of BOTOX® to Italy a number of years ago and letting it cook in the hot Italian sun during a two week bike trip. They they reconstituted it, used half to treat a sister, who got an excellent response. The remaining BOTOX® was frozen for a few weeks, then thawed out and injected into second sister, with equally good results.
BOTOX® may be exceptionally stable because it has a full complement of protective proteins [which are found in natural BTX-A], and which cluster around the 150 kilodalton core protein, stabilizing and protecting it. By contast, Dysport® has a partial subset of protective proteins, and XEOMIN® has no protective proteins at all.
Unrefrigerated Undiluted Botox
The recommendation is to keep Botox refrigerated before and after dilution. If it was out for three days I would not trust it.
Proper storage of Botox - is it still effective?
It would not seem prudent to use this product on a paying patient if even the slightest chance that it would be ineffective or sub par.
When we have had similar situations, we have our staff use the product rather than risking an unhappy patient. Keep in mind that, even if the patient is monitored and will be cared for in the event that the product was ineffective, his/her time is valuable and should not be subjected to another visit and potentially needless needle sticks.
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I have found Botox to be very stable in the undiluted form and the diluted form if used with preserved saline. However, because of FDA recommendations I do not inject Botox that has not been kept refrigerated.
So really no one can say for sure. I have found the results are not as profound and certainly it wears off quicker. It then becomes an ethical question. Do you inject a product knowing that it potentially may not work as well?
Unrefrigerated, non-reconstituted Botox may be just fine.
The diversity of opinion among the RealSelf experts is interesting. My hunch is that Dr. Smith is the voice of reason.
I've had Botox arrive from Allergan at room temperature due to a shipping delay from inclement weather. The product worked fine. If you decide to use the product, save the bottle and check your patient in a week or so to ensure efficacy. If there's a problem with this vial, call Allergan with the lot number, and they would likely replace it at no charge. If you feel uncomfortable offering this to your patients, inject your staff, your family or yourself and let us know your experience.
Hope this helps.
Botox is stable at room temperature
Although the Allergan and FDA advise refrigeration of unreconstituted BOTOX, over night storage at room temperature in a well air conditioned office should have negligible or no effect on the potency of BOTOX.
Testing for the FDA of Botox's effectiveness and safety had been done under certain conditions. Varying these conditions could change the outcome possibly, but this probably hasn't been studied. You should check with Allergan's scientific team who will probably tell you to discard the bottle and not take a chance. I have found their team to be very responsive!
Botox left on the counter
In our experience the Botox left out over night wears off faster and is not as effective. Your Botox rep would probably be able to help you out of this loss.
There are studies published that would indicate that Botox does not degrade after extended periods of time at room temp, however, your Allergan rep will probably just swap out the bottle for free if you ask. That is what I would do.