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Pharmaceuticals/RE; Cyclosporin anaphilaxis


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.


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: 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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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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