I recently posted about contacting Pharma Essentia due to a refrigerator malfunction and Besremi dose sitting in a higher than 46 degrees F (8 degrees C) refrigerator. I asked the question of the drug manufacturer if the dose could still be used, and how long Besremi could be unrefrigerated or kept at a higher temperature than indicated.
The Drug Safety Team referred the question to their Quality Team which got back to me fairly quickly and basically said there is "no stability data" available on Besremi time at a higher temperature and decisions on its viability have to be made on a case-by-case basis. They recommended that I NOT use the dose I had. So as Hunter suggested, the answer is less than satisfying. Perhaps over time Pharma Essentia will develop some "stability data" as many other refrigerated injectables have this information. Just wanted to report back on the results of my inquiry. Thanks very much to those of you who responded with comments and suggestions!
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C_Anne_Orange
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I recently started Besremi. Currently I am at 100mcg. I had a similar issue with delivery by UPS. The temperature was 49 degrees at arrival. We called the university pharmacy and they said not to worry with minor temperature changes as long as you refrigerate quickly. It is frustrating to not have a definite answer though. I also hope that Pharma Essentia becomes more reliable with their information. Good luck and let's hope Besremi is the "gamechanger" for PV.
Thank you for posting! That is helpful information. It makes me feel a little less anxious about small variations. Agree - hopefully Pharma Essentia will develop more definitive guidelines over time. I’ve been on 150 mcg since about February and still waiting for better control of HCT & Platelets, but feeling hopeful. Good luck on your journey!
I clicked on the link included with my notification of that event, and immediately noticed your threads about the temperature issue you had with Besremi when you returned from being away.
My concerns regarding its temperature stability were similar, if not identical because of the issue I had with its shipping without adequate temperature controls.
I thought my concerns had been put to rest by one of the comments made in my thread about it by NickPV, but after reading your thread, I'm a bit less reassured.
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