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Refrigerated Tarceva


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My wife's pharmacist refilled her Tarceva and stored it in the refrigerator ( in the original, manufacturer's foil sealed container ). Looks like it was in the fridge for ~ 24 hours before I picked it up. Refrigerator temperature would be below the manufacturer's recommended storage temperature range. Because the container is sealed I'm not really concerned about moisture damage but I'm concerned about cold storage stability generally. I can't locate any cold storage stability info on Tarceva ( or Iressa ). The manufacturers don't have any specific knowledge about this subject, either. Just guessing. Actually, there is very little, if any, cold storage data available on any non-refrigerated pharmaceuticals. Studies deal primarily with freezing and high temps. Does anybody have any experience with refrigerated Tarceva ( or Iressa ) ?


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If the recommended storage condition states a specific temperature range, and you know it was stored outside this range then I would ask for a new batch that comply with the storage conditions. Is this possible? Usually when companies conduct "storage condition" testing they do test the product at a range of different temperatures, so you may be able to obtain this information but only if the tests were done at that temperature.




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Thanks for the suggestions but I've already contacted the various manufacturers and I even made my inquiries as a " healthcare professional " ( which I am ) in an attempt to get a better response. No luck. These people can tell you alot about marketing but nothing about cold storage. Just educated guesses that it's no big deal. I've even exhausted all of my professional contacts and reference sources. Nothing. Just thought I'd take a shot at asking the board if someone taking Tarceva ( or Iressa ) had personally dealt with this issue. Probably nothing to worry about but I'm too close to the situation to brush it off so quickly w/o digging deeper. BTW, since we are on the topic of drug storage, and many cancer-related pharmaceuticals must be kept refrigerated, base on my experience just about the # 1 drug error that I've seen in the clinical setting over the years is failure to refrigerate pharmaceuticals that require refrigeration. This is a major problem that is, unfortunately, easily covered up once discovered. Sometimes to the patient's detriment. So, be vigilante.

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