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Pharmaceuticals/RE; Cyclosporin anaphilaxis

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Question
You mentioned that 'dedicated facility is required for Cyclosporine compounds due to concerns about Anaphylaxis'. However I could not find the evidence in the MSDS or the package insert of the compound. I would appreciate knowing more about back ground information on Anaphylaxis to the compound.

Answer
Atsuki-san:

The incidence of anaphylactic shock with cephalosporin is far less than with penicillin, but it does exist. There are many articles in the literature discussing this (for example: http://www.carloshaya.net/biblioteca/contenidos/home/produccion/jaci1.pdf). For many more articles - Google the terms "cephalosporin anaphylaxis".

The reason package inserts and MSDS do not mention this is that the condition is rare and was probably not observed during clinical trials.

Lastly, a cautionary tale:

On behalf of a Japanese client we approached FDA concerning whether there is a problem manufacturing penem products (a sub-class of cephalosporin) in the same facility as cephalosporin product. After two lengthy meetings at FDA HQ, and then waiting 13 months for a formal FDA written response, the FDA position was that some people are sensitive to penems that are not sensitive to cephalosporin - so NO, we needed a separate facility to manufacture penems.

I hope this assists - even though it is probably not the answer you were hoping to receive.

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