Shayna, sorry you are upset by a doggone blood test :hug: that should be simple.
I could not get it done in CO-my dr wouldn't be a part of it. I don't think if the dr is willing that it's that big a deal for them to register :confused:

Do you have a case manager with Active Source-he usually can help me more than just talking to the rep that answers the phone. Since I spend winters in AZ it was important to get all my ducks in a row for the switch-he made it easy and now anyone I talk to can accomplish it.

Good luck with CA
Linda

I have a Senior Tysabri Leader at Biogen who is trying to find a place for me to have the blood draw. My neuro wanted to be part of the study since she has many patients on Ty but Biogen and their rep made it impossible for her. They constantly changed their mind about how things should be done, what order they needed to be done, etc. It's hard to believe that there is no one in the entire state of Nevada who can do the blood draw.

It's ridiculous. The lab kits are provided by Biogen and after the blood draw they are returned to Biogen for the testing process. I don't understand why it is so difficult :( My neuro wasn't the only one in Nevada who gave up.

Thanks for your well wishes, everyone. I'm leaving for California tomorrow and I will be there for 2 weeks. Perhaps I'll be lucky and Biogen will find a place in central California for me to be tested. I'm keeping my fingers crossed. I would even be willing to go to southern California if it was in the L.A. area. It's a long drive but it would be worth it for piece of mind.

hugs,
Shayna

hi all. i finally got into see barrow neurological ms clinic and dr okuda wants to start me on tysabri so i hope this helps. they said it may take up to a month, drew some blood for the jcv testing etc. wish me luck! :)

after reading about everyones troubles, plus the potential side effects, i am going to call dr okuda on monday to see if i can get the oral meds instead. i hate needles and infusion sounds like a horrible way to spend a day :/

I am :confused: The infusion takes 1 hour then you stay for 1 more hour to make sure you don't have a rough side effect (I haven't heard of any in the hour after but some need Benadryl while being infused). Pretty sure the troubles you've been reading about were those trying to get tested for the jcv, which you've already accomplished. The side effect of pml is almost not existent for the first 2 years.
I am not trying to talk you into Tysabri, just wanted to clarify some of your info ;)
Linda

i'm more speaking of the problems with veins getting shot etc. i hate needles, especially if they hurt. when they took my blood to test fior the jcv antibody they had a rough time finding a vein. i can handle an iv, how does it compare to that?

I, too, have issues with finding/getting a vein :( I have found that if I hydrate well, keep my hands/arms warm and tell the person doing the infusion that I have deep/rolling veins (and then she listens :)) that it usually goes well!!

Good luck with whatever you choose.
Linda

Clark, first of all, welcome to the Tysabri thread.
I had my 46th infusion today, piece of cake when I compare it to giving myself a shot, whether it's daily, every other day, or once a week!

Infusion is the same as starting an IV because it IS an IV. It's called an infusion because that's what you are doing with the drug, infusing it. They start you with saline solution, then start the drug, then you go back to the saline for the observation period. If you've ever had steroids, it's the same procedure except for the wait time for observation afterward.

Most infusion centers will have lidocaine on hand to numb the area, They use a tiny needle and they inject a tiny amount of lidocaine under your skin where they are doing the stick for the IV and wait a minute or two for it to numb up and then go for the IV stick. Tell them you have pain and needlephobia and ask for the lidocaine if they don't offer it.

It took me 2.5 hours today from start to finish.

It sounds like your doctor is already a part of the JC study and that you won't have any trouble with testing for PML. A lot of us have been on Tysabri since before the test came out for the trial and some folks are having a hard time being tested.

Good luck with whatever you decide. Let us know how it goes!

I still read the tysabri posts from time to time because I am still occasionally bitter about my experiences with it.:rolleyes: I was just going to mention that my neuro's office never had me stay on the saline during the observation period. Is that part of a new protocol or was it always supposed to be done that way?

I usually get the saline to flush the tubes of Ty so I get it all. When i'm lucky, the nurse just flushes with 2 50ml maybe? syringes and i'm out the door. I'm still progressing rapidly so honestly Copaxone worked as good if not better. I hate the shots so I might just keep fading on Ty.

Thanks! my only problem is that they never even spoke to me about the program, jsut said they wanted to start me on it. i was disappointed i am still waiting on any treatment besides gabapentin. i'm worried i wont get any better (i currently use a walker but can walk without it through the house- sometimes). i got an "infusion blanket" in the mail the other day but other than that havent heard anything. someone from the clinic called me on thursday, but only asked me to call, then didnt answer or return my call...................... frustrating!

EddieF, sorry you are not doing well on Tysabri :(

Wishing you well,
Linda

Possible new treatment for PML
 

This is quite interesting--2 experimental drugs in PHASE II trials have been used to successfully eradicate PML in 4 weeks tops. I don't know if this also prevents the patient from getting IRIS after the virus is removed.

Someone in my MS clinic got PML and my neuro told me they flew in experimental drugs to treat the patient. I wonder if it was this?

http://www.medicalnewstoday.com/articles/209637.php

#51 & Good News MRI/MRV
 

Fri I had my 51st infusion; went the same as the 50 before it :D

Before my infusion I had an appt with my neuro to get the MRI and MRV results. The MRI was normal (glad something is normal about me :wink:). The BEST news was my MRI. Since MRI 7 months after starting Ty I have had no new or active lesions and some of the old were getting smaller. This one no new or active lesions and almost all the old are gone :D:D:D My husband looked at the one before Ty; scared the you know what out of him-so many lesions and lit up like a Christmas tree. He was thrilled to see this one! YAY!

Linda

WOW!!!! Congrats on the good news. Some of the lesions are disappearing? That is amazing... At what infusion number did the neuro notice the shrinking lesions? I'm so happy for you--it really makes you wanna stay on this drug. :D. Like you I have had no new or enhancing lesions after 24 infusions. I go for 25 in two weeks. I was thinking of dropping Ty but I'm undecided. The Gilenya long term damage side effects (lung, heart, eyes) has me slightly concerned. I do love my Ty. Anyhow, happy MRI and holidays! :)

YAY Linda!
It was absolutely the best thing I ever read when I read my MRI report the first time it said "no new lesions, no enhancing lesions, some previously noted lesions no longer visible, large enhancing lesions previously noted have reduced in size"!!

MRIs that followed continued to be better, bu it was that first one that still gets me going! :)
Funny how we love watching the lights go out! :p

Your doctor should have explained it to you in detail, but I guess some docs just don't do that. It's not right that a doctor would expect you to just take what they tell you to without explanation! Ask questions and take notes when you go to your doc. Call if you need more information. You pay them and they should give you the service you need. Be proactive!

The clinic or infusion center should have returned your call, but I am willing to bet that they called you to schedule you for infusion and that the process is further ahead than you think. Call them back if they haven't called you back. Be proactive.

As for Biogen (the pharma that distributes Tysabri) they should have contacted you by now with the name of your case worker (or whatever they call it now).

When I was waiting to start, they called after a month and gave me the old "welcome to Tysabri" speech and I lost it, because they were supposed to investigate costs for me, give me the start date after my infusion center had been trained, etc and I hadn't heard from them at all. They didn't have it together way back at the start. I hadn't been scheduled, hadn't found out what the cost would be, etc etc etc. but that was long ago, after Tysabri restarted and they had to get their program in place.

What you need to know is that all they do now is ensure the infusion center is trained and approved, make sure that you are registered and make sure the drug is there for you. and I bet that is already done, since the infusion center more than likely has patients already on Tysabri.

My advice is to go to www.Tysabri.com and register. There's a lot of info available there for new patients that may answer questions you may have. There's a good support system in place there now. Some people don't need it after awhile and some do and it is there if you need it.

One thing you said struck me. You are afraid you won't get any better. What are your expectations with this drug? It's important to understand that Tysabri is not a cure. It's designed to slow the progression of the disease and reduce the frequency of relapses. It doesn't cure you. You will still have MS and anything else you get out of it besides what it is designed to do is gravy.

Some folks have amazing results. Some folks just stabilize. In my case, the disease process has stabilized and I have seen improvement. I still have some spasticity and I still have fatigue but I treat those symptoms with other medications and I can live with that. My primary symptoms were vision and cognitive stuff and the problems that go along with that, and those are back to pre-diagnosis levels, but I would have been happy just having the serial relapses stop. I was having relapses every three months or so and my MRIs went from 4 lesions to "uncountable" in a very short period of time, and that has stopped too.

For some, it doesn't work at all, they develop antibodies and have to go off it. It's like the rest of the MS drugs, they either work for you or they don't, and you try something else.

Let us know how it goes for you!

Hi Barb!
The protocol seems to be different depending on your infusion center.

My infusion center sticks to what they were trained to do. They start the infusion with a 1000ml bag of normal saline solution and ask the questions required by the registry program, and call for the pharmacy to bring up the bag of Ty/saline mixture. It's not mixed until the verification is all done.

While waiting the infusion center does vitals, verifies the order is in place and when the bag comes, they hang the Tysabri bag and hook it into the line and shut off the saline and start the Tysabri bag. They set the infusion pump for an hour and I sit there until the hour is up and the bag is gone. They check my vitals again during the infusion. Then they restart the saline, reset the pump and I sit there for another hour.

They do another vitals check and I sign the paper and I am OTD. I finish the bag of saline in the time before and after the infusion of Tysabri. They refuse to let me leave early, even after 46 infusions. They've let me go down the hall to my doctor's office but that's it. I have to check back with them when I am done with the doc so they can verify I am not dead yet or having any reaction. In one way, it's reassuring to know that they will do it the same every time, in another way, it's irritating to have to sit for an hour after I am done because I want to GO! :D

Good find Natalie!:)

Let's hope that this turns out to be a viable solution and doesn't have some strange side effect that is worse than the cure! :rolleyes:

Tysabri # 12 on Friday
 

I have #12 on Friday.....saw my Neurologist today to review my MRI results. Great News! I have zero new or active lesions! December 2009 my scan showed over two dozen new lesions! Prior to 2010, each of my scans have :trampoline:showed dozens of new and active lesions, so this is just amazing!

Sorry Natalie, I can't remember for sure when lesions started shrinking - think around 2 years and around 3 yrs some gone and now after 4 almost all gone YAY!! Happy dance :D From what I understand Ty stops attacks on the brain giving it a chance to heal itself-love it!

Grammie - with lesions shrinking, did you gain any sensory or motor function?
I'll have dr order mri which will be 13 months on Ty. I have the feeling (or lack of) that I have many new lesions. Stength is there but loss of sensory & new spasms is bothering me. Maybe i'll give Ty 1 more month with LDN since i'll sleep better next week when I get my oxygen concentrator come Monday. Bought it.

Eddie, all I can tell you is I have had no progression-thank G-d. When I started Ty my sx were increasing-they backed off got better and have held. I have a lesion in my spine that I've been told is the reason my R leg drags-I now use the Bioness L-300-from what I've read Ty does not help lesions in the spine :(
I did not think you could take LDN with Tysabri :confused: I would've liked to, was told only with Copaxone.
Linda

Great news Amy :D Glad Tysabri is working for you !!!
Linda

Infusion #40 tomorrow morning and I have a question to ask my infusion dr. I finally received the jcv test and I'm in the stratify 2 study....yeah:trampoline: When I had the blood test the neuro who took my blood and also did the infusions in his California office asked if my infusion dr was dong a few other blood tests: CC4; D4; Tysabri Elisa(sp??) Test. The only thing my infusion dr tests are my CBC and liver functions. So I need to find out if other tests are important. I can't wait to get my results :) Ty has really helped me!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! !!!

Biogen actually came through for me. The senior Ty case manager found a place for me to go while I was in California visiting my family. It was a 4 hour drive each way for that blood draw but it was worth it :) We arrived home last night after being gone for 2 weeks. I'm exhausted...LOL

It was wonderful to read how many people are doing well on Ty :) I've adjusted to the infusions...I'm really scared of needles but if that's the only way to get Ty then I'll handle it!!!!!!!! The inside of my elbow seems to be the best place to insert the needle.

Happy Holidays everyone

hugs,
Shayna

I love the lights on a Christmas tree SO much better than on an MRI!

thanks for your input and advice riverwild. i'd probably have had a heart attack from stress if not for this place (and xanax)

I am happy all worked out for you-I know you were stressed-and glad Biogen came thru !
Congrats on #40 :D
Linda

Well I saw the neuro today to decide about staying on Tysabri or going on Gilenya. I learned some interesting things. I will post the Gilenya info in the gilenya/fingolimod thread. First, the JC antibody assay test is now available as part of the clinical trial at my clinic. But my neuro is not certain it is worth doing right now. He has some issues with the test itself and how "specific" it is (ensuring everyone who tests negative really doesn't have the JC virus). The discussion about his fear that the test is not 100% accurate (meaning no false negatives ever) was pretty scientific/statistical because he also has an MA in epidemiology as well, so I won't recount it.
See this website for more info if you can even understand it.
http://www.aan.com/elibrary/neurolog...01010070-00009

Apparently he has been talking with Biogen about the possibilities of false negatives. Until they work the kinks out and put the test on the market (Biogen told him they estimate 6 months) he thinks it won't help patients much right now with making decisions about risk or necessarily helping reduce anxiety. He did tell me I can enter the stratify trial and the researchers will tell me what my test results are. But he is not totally certain about its usefulness right now. I took him at his word because I think he is brilliant and decided not to get tested. If it's negative there is no guarentee that it is accurate and if it's positive I still may never get PML but I have caused myself a LOT of anxiety and fear for the next few months.

I decided I will get an infusion in Dec., then one in Feb., then possibly in April. That pushes me into June (since I get it every 8 weeks). By then the official Biogen test will be out hopefully and more people will have been on Gilenya and/or switched over from Tysabri to Gilenya and we will have more info on the drug. I'm just not sure I'm ready for Gilenya quite yet and think I will keep on with the PML risk for a bit longer.

He told me that neuros don't all agree on this next item, but in his mind even though I've only had 24 infusions he considers time on drug not number of infusions as the marker of true risk. So in his mind I've been on it 2 1/2 years. That was slightly nervewracking which means theoretically my risk is greater than I thought. So why not keep on for a bit longer if I've already crossed that "2 year" threshold.

I posted something recently about the experimental drugs used in that one case of PML. Apparently it was in my home state and my neuro consulted on the case. He said the drugs worked well and if a patient of his gets PML he will use that protocol.

Okay, after this long and potentially confusing post what this all means is I am staying in the Tysabri club a little bit longer. :)

4 new PML cases in MS patients on Tysabri, 1 new death -- total now 79 PML cases
 

Biogen has announced 4 new PML cases in MS patients on Tysabri, and one new death. From Reuters, December 16, 2010:

Quote:Biogen reports four more Tysabri cases, one death

* 79 confirmed PML cases as of Dec. 2, with 16 deaths

* Estimated incidence of PML per 1000 patients is 1.0

NEW YORK Dec 16 (Reuters) - Four more patients taking Biogen Idec's (BIIB.O) multiple sclerosis drug Tysabri have developed the serious brain infection known as PML and one of them died, according to the biotechnology company's monthly update.

The four new confirmed cases of potentially fatal progressive multifocal leukoencephalopathy, or PML, were detected between Nov. 2 and Dec. 2, the company said. That brought the total number of confirmed cases as of Dec. 2 to 79, with 16 deaths.

Biogen, which markets the drug with Ireland-based partner Elan Corp Plc (ELN.I), said the rate of PML cases per 1,000 patients has edged slightly higher to 1.0 from 0.96 and is likely due to more patients being on the drug for more than two years.

The chances of contracting PML tend to increase the longer a patient is on the drug, which is considered the most important growth driver for Biogen and Elan. The incidence of PML cases per 1,000 patients who have received between 1 to 12 infusions of Tysabri is just 0.01, but that rises to 2.05 at more than 24 infusions, according to Biogen's statistics.

...

(Reporting by Bill Berkrot. Editing by Robert MacMillan)



The entire article can be seen here.

well agate that is disturbing news. i hope they can get to the bottom of this.
as for me, i finally heard from biogen and i told them to place my tysabri on hold until i get in to see the mayo clinic, as i am unimpressed with barrow's ms clinic, and i figure its been 5 months already one or 2 more without treatment isnt going to kill me. plus i'd like to try that oral med first, if my insurance will cover it...

If anyone has found out how many infusions the Nov 2 - Dec 2 pml cases have had please post. I have tried every way I know to find this out with no success :mad:
thanks
Linda

The only info I have found concerning the new PML cases was that case #76 was in the USA and had received 34 infusions. I found that info here:

http://chefarztfrau.de/?page_id=716

I know that the chances of getting PML increase with the number of doses. That's very obvious from the chart in the link above. But, I don't know what Biogen is saying about the ratio now. It must be greater than 1 in 1,000.

I called my neuro to see if I could get an appointment before the end of the year but she's taking 3 weeks off so her office is closed. After talking to the neuro who did the JCV test for me I really want to know why she has never had me tested for CC4, Tysabri antibodies and also for Tysabri levels in my blood. Some neuros do this routinely for their Ty patients others don't. I would like to know the reasoning behind whether or not the neuros do the extra blood draws. The oncologist who administers my Ty infusions told me that he can only test CBC, electrolites and see if there is any liver problems. It's up to the neuros to handle anything else concerning m.s.

take care everyone........tr to have a great week :)

hugs,
Shayna

shayna, the number 34 that you see after case #76 on the chefarztfrau list means that it was the 34th case in the USA. No information about the number of infusions for the new cases has appeared yet on that site.

Thanks agate.....I didn't realize that. I guess we'll simply have to wait until Biogen releases the info :(

hugs,
Shayna

Well I got number #25 today. No problems and no side effects this time. Yeah! I was in and out--they were extra efficient. I didn't have time to feel crummy for the usual day or two so I'm glad it felt like nothing! I have too much to do before Christmas Eve as we are off to Italy. I was feeling anxious and teary today and realized it was the whole PML fear. I had set my ultimate stopping point as #24 and so maybe realizing I am going over that caused some anxiety. Anyhow hope everyone has a nice holiday! :)

White Blood Count
 

I need a favor. My WBC has been off the charts and today at dr's office I had him dig in records and turns out my WBC was 10 (high but now its 20) the month BEFORE starting Ty (Nov 2009). Biogen didn't log bloodwork during trial (amongst every other co ive asked) so can you please tell me if any of you have elevated wbc? Thanks. After all, it's what's eating us up right?

ed

EddieF, I hope somebody will reply to your question.

There has been some additional information on the PML cases:

The chefarztfrau Website, which seems to have access to internal sources, is listing 3 more PML cases:

#80 - Female, 29 months on Tysabri, Germany
#81 - Female, 34 doses of Tysabri, USA
#82 - Male, 50 doses, Poland

There is added information for cases 75-79:

#75 - Female, 33 months on Tysabri, Germany
#76 - Female, 49 doses of Tysabri, Hungary
#77 - Female, 49 doses, USA
#78 - Male, 25 months on Tysabri, Germany
#79 - Female, 24 months on Tysabri, Australia

http://chefarztfrau.de/?page_id=716

Bye for now Ty
 

Told neuro today switch me back to Copaxone. Tomorrow will be my last Ty for who knows how long. I'll do C for a few months, hopefully my white blood count comes down to earth, then i'll try Novantrone or Gilenya. He said Gilenya & Novantrone are kinda the same. I chose C as a bridge to Novantrone or Gilenya. I'll let ya's know if white count comes down in a few months. Tomorrow will be my 14th? dose of Ty.

Hi Ed!
Do you have the WBC done before or after infusion?
I ask because when my WBC is done after infusion, they are in the high range. The doc explained that it will be higher than normal because the WBCs are circulating in the bloodstream but cannot attack the myelin by crossing the BBB because very few of them get through, so they are milling around with no place to go until they die off or find another infection/inflammation to fight. They come back down as the month goes by. Tysabri also attacks the WBCs when they are immature, killing them off before they can cause any damage to the myelin.

If your WBCs are high right before you have your infusion I would be asking questions about other low grade infection/inflammation, such as diabetes, arterial disease, low grade infections in other parts of the body, etc. Even gingivitis can cause high WBCs because it is a chronic inflammation, although a person may not feel ill from the infection. Any disease process that causes inflammation will increase WBCs.

This is why the big long fact sheet that is included every time you get anything about Ty includes information about infections, because in some people, Tysabri lowers the WBC to levels that don't fight infection /inflammation as fast as they would if there was no Ty in the system.

In my case, the WBCs are never above the high normal range, nor are they below the low normal range. My doc says it's because I am disgustingly healthy and he can't make any money off of me because of that...:p