Tysabri FDA Release January 2012 about PML

[hotwing]

I am posting a link and information I read today on the FDA website about Tysabri and the risk associated with PML this was posted January 2012.

This informaiton is what I had been searching for since I have been on Ty for 35 treatments as on this Monday. I also had the JCV antibodies test and I am positive for the antibodies. My current risk is 4/1000. I am trying to look at this without making a hasty decision about my medication plans.

Just Thinking??????
I hopes this helps other if you have been searching for this information.

http://www.fda.gov/Drugs/DrugSafety/...e&utm_term=PML risk factors&utm_content=1

[Redwings]

Thanks for posting the link. This is a great opportunity to stress a couple of things that have been misunderstood about the JCV antibody testing. Perhaps the two most important points in the FDA bulletin are:

1) "For purposes of risk assessment, a patient with a positive anti-JCV antibody test at any time is considered to be anti-JCV antibody positive regardless of the results of any prior or subsequent anti-JCV antibody test."

2) "Patients who test negative for anti-JCV antibodies are still at risk for the development of PML due to the potential for a new JCV infection or a false negative test result."

[lindaincolorado]

Thanks for posting hotwing!

[REG53]

Thank you for the information.

[0485c10]

Originally Posted by Redwings

1) "For purposes of risk assessment, a patient with a positive anti-JCV antibody test at any time is considered to be anti-JCV antibody positive regardless of the results of any prior or subsequent anti-JCV antibody test."

and...

Originally Posted by lindaincolorado

I reported on 4/17 a blood test from Quest labs that was negative. So now I have had two negative blood test which means the one positive test was false. I don't know how else to explain it to you 0485c10.

Thanks for emphasizing this detail Redwing, that was so confusing to me as i read linda had a previous + overturned.

I could almost hear her teeth grinding over the internet as I questioned the reversal..she was irritated, no doubt about that! Careful caps are expensive, I know I'm a teeth grinder

I'm thinking about factors that could have caused her unique reversal...

1. The fda does not issue rules, the fda issues guidelines that a doc may or may not use.

2. positivity of jcv test is a range and a positive might be in the lower end of the range, not VERY positive, making the 2 negatives override a not VERY positive test?

3. The positive test was taken during the trial which may have established the final range for positive values...ie the positive test may have been positive for the range that was being used in the trial, but after the trial a "final" range was established to determine positivity ...therefore the positive test might not be positive based upon a final range for positive values? Making it 3 negative tests based upon the final range & her doc is following FDA guidelines.


more simply, the positive test was obtained during a trial makes it different from those done outside a trial.

4. her doc is just not a fan of fda guidelines?

[hotwing]

Originally Posted by hotwing

I am posting a link and information I read today on the FDA website about Tysabri and the risk associated with PML this was posted January 2012.

This informaiton is what I had been searching for since I have been on Ty for 35 treatments as on this Monday. I also had the JCV antibodies test and I am positive for the antibodies. My current risk is 4/1000. I am trying to look at this without making a hasty decision about my medication plans.

Just Thinking??????
I hopes this helps other if you have been searching for this information.

http://www.fda.gov/Drugs/DrugSafety/...e&utm_term=PML risk factors&utm_content=1

[B]Since I posted this I have talked with my Neuro's office 3 times and have called my insurance company and spoke with resources at Gilenya and tried to get some answers (I really wanted to know how much the med is monthly and to see if they know how much my insurance company might pay if I gave them the company name. I only wanted a ball park figure.

First of all I must say that the insurance company would not be able to tell me what I would have to pay for the Gilenya since is was not on the standard list. I was told to have the doctor's office contact a 1-800 phone number to my insurance company and they could run a test to see what the coverage would be.

I then called to my local pharmacy and they told me that they would need a RX to run this through to see what I will have to pay so this did not work either. I must say in the past this has worked and they just back it out of the system. It is most likely because having the prior authorization. I understand that but it was worth the call.

Being irritated by both the insurance company and my local pharmacy I went back to read more on the Gilenya web site. They have an assistance program that is not based on income. Gilenya informed me that I needed to fill out the form and get with my physician. I told the representative that I ONLY saw mention about the form on the site. The Gilenya rep told me to print the form and get it to my doc to fill our their part. I was really irritated by now because I wanted to potentially start using this new medication and they were not aware about their own web site and it functions. You can not print the form or download the form. The Gilenya rep told me that she could take my name and location and state and my doctor's name and have a representative contact them and they would direct the physician.

Being a nurse of 30 years now I am real irritated because I know my neuro knows all the bells and whistles that have to be done for this process. I was just wanting to know how much I needed to pay for this medication and see what all I needed to do prior to contacting my neuro.

I mean I realize you have to get your eye exam and clearance an your ECG and have clearance from a cardiologist and liver testing.

I had a long discussion with my husband last evening and my pastor of many years about this situation.

Today was a new day and I decided to call the neuro office again and ask a few simple questions I was now pondering in my brain.

1. What are her thoughts about me starting Gilenya, and if I want to give this a try how long do I have to be off Tysabri prior to starting "G"?

2. How favorable does she feel about what she is hearing an knows about BG-12 and the potential for me going on this med if it comes out this fall?

3. Should I start stop Ty, wait a period and Start on "G" until BG-12 comes out changing meds 3 times in 1 year?

Neuro called me back and in the mean time I had for the most part made my mind up on what I wanted to do but she had the same idea that I did about my plan so this was an easy solution for now.

That is to stay on the Tysabri for a short period longer. Come off in time to have a break between meds with the hopes of starting on BG-12 in the fall. If this doesn't work out we will re-think our plan in a couple of months. BG-12 should be finishing the study by June of 2012 and fast tracked for approval.

What a plan and a relief having this off my plate for now. So for now I will stick with the plan and have a couple of more Tysabri treatments. Ty has been great so far with no complication so hopefully I will make it through.

Well wishes to all on Tysabri, and hopes that BG-12 will be as good as predicted. I can't wait untill BG-12 has some wild name like all the other meds. "HAPPY TRAILS FOR A COUPLE OF MONTHS"

[0485c10]

hotwing, whew thats alot of mental processing that had to happen rather quickly. you concluded as i would, but it is scary knowing you have the virus..

I just want to add to your calculation--i hope in a way that will be a relief to you?

The trials for BG-12 are already done, biogen submitted the completed application on 2/28/2012.

since bg-12 is already in use as a med for psoriasis, the fda should approve soon.

batman said his doc had offered to prescribe off label,
but if you wait for FDA approval, a suggested dose will be known.

You can read the articles about bg-12 fda submission, by going to my homepage where i maintain a list of links to interesting articles. Scroll down to the date 1/15/2012 where i started the articles on bg-12--the articles of bg-12 FDA application on 2/28/2012 can be found there.

Originally Posted by batman12

bg-12 is not a new drug - it has been in use for a number of years in treating psoriasis.

My first neuro offered to prescribe it to me off label

[0485c10]

PS, I added your link to my home page..it wasn't there before you posted it. hope you don't mind.

[hotwing]

Originally Posted by 0485c10

hotwing, whew thats alot of mental processing that had to happen rather quickly. you concluded as i would, but it is scary knowing you have the virus..

I just want to add to your calculation--i hope in a way that will be a relief to you?

The trials for BG-12 are already done, biogen submitted the completed application on 2/28/2012.

since bg-12 is already in use as a med for psoriasis, the fda should approve soon.

batman said his doc had offered to prescribe off label,
but if you wait for FDA approval, a suggested dose will be known.

You can read the articles about bg-12 fda submission, by going to my homepage where i maintain a list of links to interesting articles. Scroll down to the date 1/15/2012 where i started the articles on bg-12--the articles of bg-12 FDA application on 2/28/2012 can be found there.

Thanks for the links and I really do appreciate that. I have been so engulfed with the Tysabri issue this week that my plan was to research the BG-12 topic next week an WOW you saved me a lot of time on that one. Thanks for the info and the link and I am glad that you posted the link I had. I have a question for you. How can I keep up with your post on here. You seem to be very much in the know and I am glad and would like to keep up with your post. I still am some what new to how all this works on the site. If you had not given me specific instructions I would not have found your links for sure. Thanks again.

[hunterd]

Hot, what did u find out about bg-12? I'd check the website but i'm on my nook and tomorrow i get to have my eyes dialated. Looks like my day is pretty shot tomorrow!!!

[hotwing]

Originally Posted by hunterd

Hot, what did u find out about bg-12? I'd check the website but i'm on my nook and tomorrow i get to have my eyes dialated. Looks like my day is pretty shot tomorrow!!!

Huntered read up 3 posts on this thread to the remark from 0485c10 and the link to home page is listed under the date 1-15-12. BG-12 has already been submitted to FDA approval in February.

This is wonderful news for the MS community for sure in my opinion. The treatment approach is totally different from the other MS medications for prevention of disease progression. Less side effects, and it should be on the market for use by the fall as it has been in the news and media. BG-12 is already being used for Psoriasis and because of that i personally do not see any problems as BG-12 moves forward.

I hope this answers your questions. Have a great day.

[0485c10]

hotwing--email is in profile if your interested?

[soshime]

i think it's only a one-month wash-out to go from Tysabri to Gilenya - tho out of MY personal paranoia about PML, i went for a 3-month washout period.

Hey, has anyone else heard anything about a "new" drug in the pipeline, that will probably finish its next phase of tests in 2014 called ONO-46141? see the link below. it's listed on the gov't clinical trials page, but participation is by invite only.

http://www.drugs.com/clinical_trials...nts-13353.html

let me know if you've heard of it - my neuro is teasing me with it!

- soshime

[0485c10]

Originally Posted by 0485c10

This article adds the information that the patient was jcv+ and had been on tysabri for 3 years.

This article says that biogen/elan recommend 3 month washout period between the 2 meds,

http://www.irishtimes.com/newspaper/...314729546.html

Biogen/elan recommends a 3 month washout period between new med--so that not unusual, or shouldn't be.

someone else posted that she had read the person who got pml after starting gilenya had only had a 6 week washout period, which confuses things because if the pml had occured at 6 weeks BEFORE starting gilenya it would have been known without a doubt that ty caused it--now only known for sure that gilenya didn't stop pml. i'm pretty sure no doc will make the mistake of starting anyone on a new med before 3 months, maybe only copaxone?

the RMTms center, dr. vollmer, had been running trials of starting copaxone BEFORE stopping tysabri, then stopping tysabri while continuing copaxone. I wonder how those trials worked? as it seems that stopping tysabri after over 2 years of use while jcv positive is a problem.

[hotwing]

Originally Posted by 0485c10

hotwing--email is in profile if your interested?

I HAD A QUESTION BUT DID NOT SEE THE CONTACT INFORMATION. I WILL POST IT ON THE MESSAGE BOARD LATER...