Talk:Defibrotide

Lack of evidence for use on renal (kidney) dialysis

On pubmed I found only 1 study http://www.ncbi.nlm.nih.gov/pubmed/1428206 There is also a study (but without abstract on line) about its use on Iga nephropathy (kidney disease) http://www.ncbi.nlm.nih.gov/pubmed/8700366 Both of the above studies are old. 688dim (talk) 19:17, 4 January 2015 (UTC)

What is it precisely

It says "is a deoxyribonucleic acid derivative (single-stranded)" but how long is it, what base sequence, and how was it modified ? - Rod57 (talk) 17:00, 10 April 2016 (UTC)

How does it work

Mode of action does not explain how it increases "levels of prostaglandin I2, E2, and prostacyclin," - Rod57 (talk) 17:02, 10 April 2016 (UTC)

Where was it used before FDA approval

Should say what countries, what indications and since when - or confirm that it has been used (where) off-label. - Rod57 (talk) 17:09, 10 April 2016 (UTC)

External links modified

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Accuracy Updates

I am an employee of Jazz Pharmaceuticals, plc (Jazz). My intent is to correct misinformation related to Jazz products or related disease states in a truthful and non-misleading manner. All of the edits that I request are made with the knowledge and approval of Jazz.

In October 2013, EMA approved Defitelio (defibrotide sodium) for the treatment of severe hepatic veno-occlusive disease (VOD) in haematopoietic stem-cell transplantation (HSCT) therapy. In March 2016, the FDA approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic VOD with renal or pulmonary dysfunction after they undergo HSCT.

I suggest making edits to the initial section, the Society and Culture section, and Biological half-life under the clinical data section of the Defibrotide Wikipedia article in order to correct the information stating that defibrotide is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant and the biological half-life = a few hours.

The following edits to the initial section are suggested to reflect the approval of defibrotide in Europe and the United States:

Defibrotide, sold under the brand name Defitelio, is a mixture of single-stranded oligonucleotides that is purified from the intestinal mucosa of pigs.[1] (Please delete text from "It is used to treat..." through "having had a bone marrow transplant” and replace with the following text.)

In the European Union (EU) it is used to treat severe cases of veno-occlusive disease of the liver in adults and adolescents, children and infants over 1 month of age of people following having had a bone marrow transplant. Summary of Product Characteristics. In the US it is used to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities following a bone marrow transplant. Prescribing Information It works by protecting the cells lining bloods vessels and preventing blood clotting; the way it does this is not well understood.

(please delete text from "there is a strong.." through "hypersensitivity reactions " and replace with the following text) Defitelio may increase the risk of bleeding in the brain, eyes, lungs, gastrointestinal tract, urinary tract, and nose in patients with veno-occlusive disease. Prescribing Information Some people have hypersensitivity reactions.[1]

It was approved in (Please remove "Europe" and replace with) the European Union (EU) in 2013 and in the US in (Please remove 2014 and replace with) 2016. "FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow". March 30, 2016. Retrieved 30 March 2018.</ref> (Please add) Defibrotide is also available in Canada, Iceland, Israel, Norway, South Korea, and Sweden.Jazz Pharmaceuticals products-outside-of-us

The following edits to the Society and Culture section are also suggested to reflect the approval of defibrotide in Europe and the United States:

(please delete text from ..."Defibrotide was approved".. through "transplant in 2013" and replace with following text) Defibrotide was approved in the EU in 2013 for use in treating severe cases of veno-occlusive disease of the liver in adults and adolescents, children and infants over 1 month of age of people following having had a bone marrow transplant; Summary of Product Characteristics Gentium had developed it.[4] At the end of that year, Jazz Pharmaceuticals acquired Gentium.[4] In (please remove April and replace with) March 2016 the US FDA approved it (Please remove "for this use" and replace with the following text) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities following a bone marrow transplant. Prescribing Information

The following edit to the Pharmacokinetic Data is also suggested

Biological half-life: (Please remove ..."t1/2-alpha = minutes; t1/2-beta = a few hours..." and replace with following text) The elimination half- life of defibrotide is less than 2 hours. Prescribing Information

CPark 2017 (talk) 18:28, 30 March 2018 (UTC)CPark_2017

Your edit request contains deletions, but it's unclear whether the additional text you are mentioning concerning the drug is meant as a replacement for that deleted text — or if it's just commentary, not meant to be placed anywhere. Please advise. When ready to proceed, please change the request edit template parameter to read from ans=yes to ans=no. SPINTENDO       22:21, 30 March 2018 (UTC)

I went over this and made some changes.

We don't need or want to give the exact indications from the label; this is an encyclopedia and not a prescribing guide. I noted that the indications are slightly different in the US and EU.

Thanks for offering corrections about the date of US approval in the lead and body. Fixed that.

I updated the half life in the infobox.

About other countries where the drug is available, is there an indepedent source for that? We prefer not to cite company websites.

btw, the part that you called the "initial section" is formally called the lead and is just meant to summarize the body. Please see WP:LEAD.

Thanks for complying with the PAID policy and COI guideline! Jytdog (talk) 23:39, 30 March 2018 (UTC)