YEAH Keri!

I am so happy that you have finally gotten approved!!!! Yippee!!!!

A squeaky wheel....:D

It's ABOUT time, Keri!!!

Thanks for stopping in and letting us know! Let us know what happens and when you get your first infusion. We are pulling for you!!!:)

An update on the liver problems in a recently released Q & A document, as reported by EMEA (European Medicines Agency), on Mar 20th, 2008.

"What is the issue with Tysabri?

There have been reports of liver injury in patients receiving Tysabri. The term ‘liver injury’ is used to describe any side effect seen in a patient that could be a sign of the liver malfunctioning, such as raised levels of liver enzymes, yellowing of the skin or inflammation of the liver.

The European Medicines Agency (EMEA) is aware of 29 reports of liver injury in patients receiving Tysabri, with about two thirds of these cases being classified as serious.

The committee (NOTE: not USA) agreed that the product information should be updated to include information about the risk of liver injury. This includes warnings that patients treated with Tysabri should have their liver function monitored . . ."

http://www.emea.europa.eu/

http://www.emea.europa.eu/humandocs/...14590808en.pdf

RW, any idea why there is a discrepancy in the number of "serious" cases (4 mentioned in your prior posting) and 2/3 of 29 stated by the EMEA?

Cherie

Hi Cherie,

And some people wonder why I voice my concern about Biogen!

Harry

Keri

I got a phone call from Biogen today. Interesting information! It certainly explains a lot and your approval today! ;)

Red, I am so happy for you. April 1st is good timing on the Dr appointment. It's about how long I had to wait. I told you when things move they move fast. Congats!!!!

Could I be too weak for Tysabri
 

Good before bad

The good news is I have not had any new MS symptons since my infusion. Everyday until I got Ty I was getting worse. Everyday I had a new MS something. Now (while it has only been 3 days) I feel stable. I am so happy, but scared of getting pulled off.

I have COPD and get sick a lot. I'm worried about getting pulled off of Ty. When I took the infusion I had a very minor cough. I know I was not supposed to take it but I had too. I was getting much worse w/ms. 2 days later, I was DX with Pneumonia. I need an educated guess - do you think my system may be too weak for Ty. I feel sure I would have got sick with something w/o Ty. I'm just not sure it would have been Pneumonia. What is your guess - was I coming down with Pneumonia or did my infusion possibly make it worse. I want to stress I am not worried about PML - so Harry stay way from my post. I'm looking for thoes on TY. Oh, they did not tell me what type of pneumonia I have and put me on avelox. Yes, I did tell the neuro Dr I was mild to mid stage COPD.

It is hard to say whether or not tysabri was the direct cause, but we know that it does weaken our immune system and we are more likely to have infections. Lung infections are listed a a possible side effect. I became sick about 5 days after my third infusion and eventually was dx with bronchitis and a sinus infection and took axelox for 10 days. An urgent care doctor prescribed this as I was out of state at the time. My pcp says it is a pretty strong antibiotic. I got the feeling he thought I should have been given something weaker. I think avelox is in the same class as cipro. I went on to have my 4th infusion just a few days after I finished the avelox. I am still having sinus problems, but the infection (if I ever really had one) is gone.

I think this is a decision that has to be made between you and your doctor. but you do need to be over the pneumonia before you have another infusion. You do need to be honest with him/her. I would think that he would probably want to give it a few more tries.

Well, I suppose there's just as good a chance that the EMEA has messed up their facts . . . but either way, it proves the point that we aren't always getting reliable information from what we think would be reliable sources anyway. :cool:



The pneumonia came on just a day or two after the Tysabri infusion, and as I understand your posting, "every day leading up" to the infusion, you were getting worse . . . ?

I'm gonna go out on a limb here and suggest that you were in a psuedo exacerbation due to the pneumonia that you already had brewing, and that's why you had noticed the worse symptoms and minor cough.

When something similar happened to me last year (bronchitis + sinus infection), I was feeling absolutely MS-normal the day before, and sick as a dog the day the symptoms showed. But for the terrible chest pain, I couldn't believe it when they said I had bronchitis and needed antibiotics. Within a day, I was on the road to recovery too.

So my guess is, since your pneumonia dx came so SOON after the infusion, is quite possible that you had it before you even started on T, it just wasn't obvious yet.

BTW, a person does not have to be on Tysabri to offer a sensible educated guess. :cool:

Cherie

I would gladly stay away from your post but... I'm sure you know that pneumonia is a serious infection of the lungs. Tysabri alters the way your immune system functions. Just where is your Tysabri prescribing doctor who is supposed to be Touch Program certified in all of this? You are going on the internet to ask for information about a potentially serious situation with your health when you should be banging on your doc's door and getting some answers and treatment immediately! Please Sheena, tell us your doctor is totally aware of your situation and is taking some steps to handle it.

Harry

Dear Cherie, Harry and Me, for that matter,:)

This is a thread for Tysabri users and wanna be users to support each other in their choice. It is not a place for our kibbitzing about the media info or misinfo of the pros and cons of Tysabri.

That has all been said, argued and re-argued and now, with the data known, PwMS are making an educated choice to use Ty. We should respect that and stop muddying the waters here.

If something new comes up about Tysabri..good or bad, please start a new thread, with the important info. Let's come here, only to add our support. These PwMS know what their doing or certainly should, by now.

:grouphug:

That is how a "sticky" about "information" works normally. :confused: The instructions about this particular thread were clear too:


People who are new to this forum will not only be wanting to read about other's experiences, good and bad, and historic advice on issues . . . but also ALL the information that is available to evaluate this option and make informed choices.

While I agree the detailed conversations might be better suited to a separate thread, I believe that the links to those discussions and "new information" should also be found here (in the thread designated as "a place to keep it "together").

Cherie

Has anyone tested positive for tysabri antibodies? I have not yet heard my results (has been 2 weeks), but was wondering what others' experiences have been. These seems to be some conflicting information out there as to whether or not you should continue with treatment, particularly if you are in the first 6 months. I know that infusion reactions may be a sign of antibodies. But the Ty literature published by biogen says these can go away after the first 6 months? I guess I just need to be patient and wait until I hear from my doctor. I think it can take up to 3 weeks to get your results.

Lady you hit it straignt on, I think you are right. That is what I thought but just needed another opinion from one more educated then me. To all, I did not come here to start stupid remarks... I have the answer I needed and from a person I consider very educated on TY. Thank You Lady - BTW all - I did my research - but there is always someone more educated in the area. Harry. no one knows everything!

Barb

I know one guy that did. And he was taken off Tysabri.

You are absolutely right but if I was receiving Tysabri, I sure as heck would want the doc prescribing it for me to be fully knowledgeable about everything surrounding the drug....especially if any problems surfaced.

Harry

Barb,

I know two people who have tested positive for antibodies. One was tested after 8 infusions (found to be positive) and is now on another therapy. One tested positive after being taken off Tysabri when it was pulled from the market. When it was returned, he went back on and started having major systemic reactions. He is in hope that the antibodies were transient and that he will be able to return to the therapy. Only time will tell in his case. Those are the only two people I have heard from who have had antibodies, out of the hundreds I have had contact with who started and reported on their Tysabri experience. 99.9% of the people I have had continuing contact with are still on Tysabri and continue to report on decreased relapses and progression.

I have not been tested for antibodies because I have had no adverse events, and my 6 month MRI showed vast improvement. I would be tested if I was having reactions after 6 months or if in the first 6 months I had adverse events that continued to worsen. Your results will come back and answer your questions.

As always, Tysabri is not for everyone. It's like every other drug. What works for one may not work for another. It is not a failure, it's an intolerance. We all have them, for one thing or another :D, regardless of how much we try to be accepting or accomodating or hope they will help or that the adversity will go away.

I wish you nothing but good results with Tysabri. Only you and your doctor can say when it's time to move on. The norm is 6 months, but if it's bad for someone I would be the last one to say stick with it. It's your choice and life is too short to feel bad!

PLease let us know how your tests turn out.:hug:

Riverwild, I am hoping the results come back negative or that the level is low as I have been experiencing more energy and using my cane less on most days. Of course I do not know for a fact that these changes are due to tysabri but... Thanks! Barb

GET HELP!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! My prayers are with you!

To all members: I' sorry to have had a problem on this board. I thank you with all my heart for the help you have given to me. I would never have made it w/o you. God Bless Each Of You! ~Sheena~:hug:

That is mainly what I meant, Cherie.

Thanks..:hug:

administrative edit

Umm...is it just me or is anyone else a little irritated by the bickering on a Tysabri thread?:confused: It would be great if we could have a thread/sticky for Tysabri users and potential users.

I think we all read the rest of the MS information too (hopefully:)). If someone who doesn't fit the above criteria has info or news about Ty it can certainly be posted there.

I do not like having to weed through arguments to get updates from other Ty users about their experiences. I'm sure I'm not alone in this.:cool:

yes, I am sure it must be very negative for others, especially new members, to come onto a thread meant for information sharing, and instead find confrontational posts

here are our guidelines
http://neurotalk.psychcentral.com/showthread.php?t=1293

specifically
and
We would appreciate if everyone would respect those guidelines and each other in their future posting.

thank you
Cheri

admin edit as quoted post has been edited.

I'm confused. I went to the Neuro today for my 1st visit after my 1st infusion. While there, he talked about TY and expected me to see a ton of improvement asap. He did not seem real pleased with me. I thought I was doing well as I have only had 2 noticable problems related to MS. I mean 2 problems in addition to what I already had. One was a real bad hard pain, tingle like feeling in my hand and the other I don't recall (nothing big). Until I got TY, I was getting worse with more sx everyday. So, this is good right? He expects my mood to be on top of the world, leg better... and fast. Ty is supposed to slow progression; some and I pray me too also see real improvements. However, from what I have read this is usually after a few treatments. Why does the guy expect so much so fast. If I'm wrong, please correct.

The real good news is Lady was correct. I'm really sick now, but not due to Ty. Since I had a cough when I got the infusion, he said I would have got sick anyway. He does not see the need to pull me off. I even told him I got sick a lot compared to others, and he was not concerned.

Take Care

Sheena:hug:

Sheena, I sorry you are sick. Hope you start feeling better soon. I would be confused by your neurologist also. :confused: As I understand it, tysabri is meant to slow progression. Some have seen improvements in their current MS symptoms, but that is not even stated as a possibility in their literature. And usually if there is improvement, I think that is gradual.

I did not notice any changes in my first few months except for perhaps a slight increase in energy. Now I find myslef using my cane less than I did a few months ago. I have had 4 infusions.

:hug:Barb

Thanks so much Barb, you confirm what I thought. This guy is not my usual Neuro so I don't know him at all. Maybe he was just trying to cheer me up as I am sick and took a hard fall last night and walked worse due to pain of injury. Maybe he is just big on TY. Who cares? I just want to have my facts straight and my TY.

Thank you so much for your reply and I am excited for you!! It looks like you may just me one of the lucky ones who improves. I pray you can trash or hide away that cane very soon. GOOD LUCK!!!!:hug:~Sheena~

I am having problems with getting my neuro to order a 6th month MRI. I will have my 6th infusion at the end of April. He says it is not necessary unless I am experiencing problems. I thought they were supposed to order one as part of the TOUCH protocol?

Hi Barb,

I didn't get one until a year passed from my previous one. And luckily, it looked great! :)

Updated Tysabri Performance Graphs
 

Barb, I was trying to find the info on whether you need a MRI according to the TOUCH protocol (and didn't find it), but I did run across this information (that I think) you were asking about earlier in the thread:

Do not receive TYSABRI if you:

• have PML
• are allergic to TYSABRI

Allergic reactions including serious allergic reactions. Symptoms can include:

• hives
• chills
• itching
• rash
• trouble breathing
• nausea
• chest pain
• flushing of skin
• dizziness
• low blood pressure
• wheezing

• Serious allergic reactions usually happen within 2 hours of the start of the infusion, but they can happen at any time after receiving TYSABRI.

5.3 Hypersensitivity/Antibody Formation
Hypersensitivity reactions have occurred in patients receiving TYSABRI, including serious systemic reactions (e.g., anaphylaxis) which occurred at an incidence of <1%. These reactions usually occur within two hours of the start of the infusion. Symptoms associated with these reactions can include urticaria, dizziness, fever, rash, rigors, pruritus, nausea, flushing, hypotension, dyspnea, and chest pain. Generally, these reactions are associated with antibodies to TYSABRI.

If a hypersensitivity reaction occurs, discontinue administration of TYSABRI and initiate appropriate therapy. Patients who experience a hypersensitivity reaction should not be re-treated with TYSABRI. Hypersensitivity reactions were more frequent in patients with antibodies to TYSABRI compared to patients who did not develop antibodies to TYSABRI in both MS and CD studies. Therefore, the possibility of antibodies to TYSABRI should be considered in patients who have hypersensitivity reactions [see Adverse Reactions (6.2)].

Antibody testing: If the presence of persistent antibodies is suspected, antibody testing should be performed. Antibodies may be detected and confirmed with sequential serum antibody tests. Antibodies detected early in the treatment course (e.g., within the first six months) may be transient and disappear with continued dosing. Repeat testing at three months after the initial positive result is recommended in patients in whom antibodies are detected to confirm that antibodies are persistent. Prescribers should consider the overall benefits and risks of TYSABRI in a patient with persistent antibodies.

Experience with monoclonal antibodies, including TYSABRI, suggests that patients who receive therapeutic monoclonal antibodies after an extended period without treatment may be at higher risk of hypersensitivity reactions than patients who received regularly scheduled treatment. Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption. Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients [see Adverse Reactions (6.2)].

http://www.tysabri.com/tysbProject/t...uch/index.html
(found in the Patient Safety tab)

Cherie

Tested positive for ty antibodies
 

I jsut heard from my neuro's nurse and she said my blood work came back positive for antibodies. He wants me to continue treatment for 3 more and then be retested because they said this could be temporary. Now I know why I was having reactions during my infusions. So i guess I will see how my infusion goes next Wednesday.

I am so upset right now; I can't stop crying. Since I have had problems with betaseron and copaxone too I am out of options.

Barb

I am in the same boat you are but I am not out of options. There are other treatments out there. Don't get so discouraged.

Cytoxin
Novantrone
IvIG

You might also look into applying for a clinical trial, which is exactly what I did.

Think positive...:hug:

Barb, This is not the end of your options!

First, there's a difference between persistent and transient antibodies. You absolutely may have either. Usual protocol is to continue to treat if benefits have been seen, despite a positive test, and re-assess after three months, and you state that you have seen positive benefits. Make sure that you pretreat with benadryl or claritin and make sure they are running the IV at a slower rate. In many folks it makes a HUGE difference. Tell your neuro you want the MRI at 6 months to see whether it shows improvement, to help you decide on your next move, because of the problems you have experienced.

Second, despite how you may feel now, as Av8rgirl stated, there are other options available. Investigation into MS treatment is continuing to move forward after being stalled for YEARS! More is known about MS today and there are more meds in the pipeline than ever before, some with excellent data coming out of the trials! Look at www.clinicaltrials.gov for more information on trials for MS.

There are many folks here who have been hearing "A cure in our lifetime" for years. This IS going to happen at some point. With the advances in science in the past decade, I truly believe we are closer than ever to figuring out the whats and whys of MS. I have an up and coming Neuroscience/Molecular Biology Masters candidate in my family and she has a personal stake in this fight. It's one of the reasons she has chosen the path she is on, as a researcher.

Until it's figured out, there will continue to be better treatments designed to delay progression and reduce relapses. That's what we have now and despite the drawbacks and flaws of each drug available, and the fact that they do not work for everyone the same way, we DO have options. :hug:

When the FDA posted that warning last month, we immediately contacted the neurologist. We were told that he had already done a baseline liver function test as part of my wife's blood work BEFORE starting her on Tysabri. He told us that routine liver function tests were part of his protocol and that he expected to have her tested on a regular basis. When we persisted, he ordered another liver function test immediately (this was after her 4th infusion).

He also assured us that this is old news - that the FDA finally got around to posting it - but that most neurologists had already been aware (for years) of Tysabri's stress on the liver.

JJ

For those of you who went to the original www.tysabri.com site and found NOTHING on it of benefit, please take a look at it now and comment please!

It's a work in progress, no information for Crohns patients yet, but it's FINALLY got SOMETHING on it!!! :)

Thank you everyone for your responses. I know that this response to tysabri may be transient. I just was feeling overwhelmed after getting the phone call from my neuro. I know that there are other meds out there that I can possibly try if I continue to present with antibodies.

My next infusion is on Wednesday. I am going to have a benadryl iv one half hour prior to the infusion and they are also going to slow it down.

Let me see what I can find out for you.