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Provenge


mawyant

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FDA has recently approved an autologous product called Provenge for treatment of men with prostate cancer.  Blood is collected from the patient by leukapheresis, "primed" to instruct the immune system to attack cancer cells, and reinfused to the patient. 

With that background, this is my question.

I have urology and oncology nurses asking me for advice, since this is an "autologous blood product".  Evidently the reactions that some patients have to this product are very similar to transfusion reactions.  Should the reactions be reported as such, or what group has oversight of this product and potential for management of reactions?

Does anyone have experience with this product?

Thanks for any input!

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  • 3 years later...

Hi All,

Though i don't have experience with this specific product, it sounds as if it could fall under the same types of products as platelet gel, bone marrow aspirate concentrate etc. Maybe AABB periop folks or the hemovigilance folks would have some ideas?

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FYI... this product has been in use in the US for a few years now.  In fact, demand is starting to die down.  It's incredibly expensive, (some reports in the range of $90k) and data shows it is extending life by about 4 months.  They're hoping to get FDA clearance for additional protocols, not just prostate cancer.

In my experience this product never touches the blood bank, and therefore wouldn't be managed by them.  The MNCs are collected similar to a stem cell collection.  The product is shipped off to Dendreon for processing and is then shipped directly back to the doctor for administration.
I guess if it's being shipped back to the blood bank and distributed through them, it should be monitored similar to any other blood product.  If it's being shipped back to the doc, it falls under the practice of medicine and is not subject to blood bank review/ investigation/ work up.

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30 minutes ago, frenchie said:

My facility is regulated by New York State Department of Health, and reinfusion procedures must be overviewed by our Medical Director, and falls back under my supervision.

But thank you Smarty pants for this information...

I love how their name is smarty pants; when I first read this it sounded like you were being childishly sarcastic. Bahahahaha.

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anytime you are activating lymphocytes you are creating a real miasma of cytokines and who knows what else.  I can't imagine you would work up any reaction to these products . . . kind of like transfusing granulocytes -  they always came with a statement that the patient would have a reaction (never had to work these up).

We were doing things like this at Stony Brook in the mid -1980's.  the blood bank was never involved

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