Do you have any further information on that drug?

Wolfgang

The advent of Xiaflex seems to have triggered new ideas for competitive products. There are several new claims and patents addressing Dupuytren's. I honestly have no idea what this one is about.

Wolfgang

moondanc:

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wach:

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The advent of Xiaflex seems to have triggered new ideas for competitive products. There are several new claims and patents addressing Dupuytren's. I honestly have no idea what this one is about.

Wolfgang

I think I've read that just about any intervention-- OHS, NA, Xiaflex-while it may be helpful breaking cords or removing diseased tissue- generally/mostly/sometimes-also stimulates the disease? I know there aren't a lot of studies on Xiaflex and I don't believe the 5 year (completed just this year) study results have yet been released-- have they?--but wouldn't it follow that if Xiaflex is stimulative as it spreads through out the blood it could also stimulate that hand and the other hand? Wild theory, I know.

Diane

pia2some:

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But, Xiaflex is made so that it is not supposed to travel past certain points. I remember my doctor explaining that at a certain point in time, the enzyme has completely broken down and therefore can't move any further and damage other parts of the body. Fact is, the lymph nodes catch any of the medication as it moves through the arm. After my Xiaflex, the lymph nodes in my elbow and armpit hurt like hell and were very swollen. Now, I assume that fact is true since the drug is so powerful and they cannot have it moving throughout the body.

That all said, I'm one of those who's DC exploded like wildfire within a few months of having Xiaflex.


~ dawn

So now I'm curious and am looking around on the web. It's too late for me to look up much, but I did find this. I will not receive anymore Xiaflex, I know that much. But reading the details about this drug is scary. I'd feel much better if it had already been in use for decades. It is just too new.

"Because the therapeutic activity of Xiaflex is localized to the injection site and does not require or result in systemic exposure, the primary pharmacodynamic activity of the drug could not be evaluated in subjects and, therefore, such studies have not been undertaken.

Data from one Phase I and one Phase II Study confirmed that there is no quantifiable systemic exposure following a single injection of Xiaflex (0.58 mg) into the cord of the affected finger in subjects with advanced Dupuytren's disease or following the subsequent procedure to disrupt the cord. There has been no evidence of systemic toxicity to date in the clinical studies conducted with Xiaflex administered through localized injection into the Dupuytren's cord. Results from the aforementioned clinical Phase I and II studies indicate that no detectable absorption of any Xiaflex-derived components occurs in subjects under the conditions of clinical use.

For these reasons, no clinical studies pertaining to tissue distribution, metabolism, excretion, plasma concentration-effect relationship, dose and time dependency, effect on hepatic or renal function, and drug-drug interactions have been performed with Xiaflex.



Xiaflex is generally expected to be confined to the injection site rather than to undergo systemic distribution; however, extravasation could occur. Injection-site reactions occurred in 35% of the patients who received Xiaflex vs. 5.6% placebo.

It should be emphasized that the pharmacodynamic mechanism of action of Xiaflex is the destruction/digestion of collagen. As long as this process is controlled and remains localized to the tissue area/volume of interest the risk/benefit profile of this therapy could be acceptable. However, should the drug reach adjacent tissues, such as nerves; blood vessels; cartilage and bone; or muscle, the risk of extensive irreversible damage cannot be ruled out.


A statement has been added to the Warnings and Precautions section of the Product Monograph describing that Xiaflex contains foreign proteins and patients develop anti-drug antibodies in greater proportions and higher titers with successive Xiaflex injections."

http://www.hc-sc.gc.ca/dhp-mps/prodpharm..._147788-eng.php

~ dawn