Scary experience with Tysabri

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Scary experience with Tysabri

Postby Ronnie » Wed Nov 15, 2006 3:02 am

Dear folks:
I disappeared for a while, I know. The classes at San Antonio College started up, and I was waiting on my HMO to approve me, so I decided I needed to chill for a while.

Then, TA DA! I was approved, enrolled, and scheduled! Had my first infusion October 16th, and my second infusion November 13th. I thought that sounded ominous, but what the hey...

Last month, no dramatic change, but I seemed to feel more chipper in the last few weeks. I looked forward to the next infusion.

So, Monday at 10am my scheduled infusion came about. I answered the questions, read the Patient Info, and settled down to read from the Adobe Illustrator CS2 Classroom in a Book (light reading).

I started to tingle, I started to feel funny, my chest hurt. I said to Don, the nurse, "Ok, I am having trouble breathing now"; and he said, "Yes, you are flushing." I said, "ok, I think I am going to faint." He said, "I am going to give you a shot in the leg with an epipen." I said, "ok."

He apologised for the blood on my jeans, and he said, "You were pretty calm. I was pretty calm too." The man in the chair to the right of me said, "You were calm, I almost lost it though".

My hips and back really hurt, I guess all my muscles were starting to spasm or something. Then Don got some IV Benadryl and gave it to me, which helped a lot, and the neurologist told him to wait a few minutes and restart the infusion slowly. He did, and pretty soon I said, "ok, my feet are tingly, and my back hurts alot." He stopped the infusion and grabbed some more Benadryl. He continued the infusion really slowly then, and he kept me talking for a while about various and sundry unrelated topics, until I started to fall asleep.

The neurologist said that we will try premedicating with Benadryl next time, but if it starts to happen again, that's it. No more.

This was really odd, because I had three infusions previous to this and nothing untoward happened.

So, now I am feeling worried.
I thought my troubles were over. Or, at least, not as troublesome. And I still have a lot of grading to do.
Aaaargh.

I am glad to see that Lauren is doing well, and that Gary and Amelia have some hopes! Good luck, everyone.
Ronnie
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Postby euphoniaa » Wed Nov 15, 2006 5:06 am

Hi Ronnie,

I'm really sorry to hear of your apparent allergic reaction to the Tysabri infusion. In case you missed it, there is another discussion in this thread http://www.thisisms.com/ftopict-2901.html about the number of patients who have had that same reaction. It seems to be especially common with those who had a couple of Tysabri infusions before it was pulled and then just started T again.

I'm a little surprised that they continue to infuse so many of the patients who show an allergic reaction, since even the Tysabri information says to discontinue it at that point. From the Tysabri website: "TYSABRI® should not be administered to patients with known hypersensitivity to TYSABRI® or any of its components."

I had hoped that Tysabri would turn out to be safer even than the CRABs, because it would receive the intense monitoring that should be used, but is usually lacking in those other treatments.

Having followed the Tysabri patient experiences at several MS sites, I've also been surprised at the number and variety of miscellaneous side effects that patients are reporting. I thought that a lack of side effects was one of the main selling points of T.

I guess we really won't know much about this drug until enough patients receive the treatment in the general MS population that they can develop a database of results.

I wish you the best in your treatment, but please be careful! Anaphylactic reactions are one of the most serious of side effects. Please continue to keep us posted on your experience.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Postby Melody » Wed Nov 15, 2006 6:07 am

Anaphylactic shock is not good at any time. I'm also flabbergasted as to why they continued the injection. After the epi injection you would have thought that was enough. John has been in anaphylactic shock several times and the last 2 were just prior to a relapse so monitor yourself closely. The relapse occurred within the 4-6 week range which if you understand allergies at all is within the time frame your system is still trying to regain control. It is not surprising to me that you didn't have reactions before as allergies tend to develop once your system is over loaded so to speak so lots of times the symptoms are more severe the next time around. Maybe you should google up some information on standard food allergies and see what they say so you know what you are dealing with. Am praying all goes well for you. A couple links to start you off

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John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.
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Postby Arron » Thu Nov 16, 2006 3:05 pm

scary! thank you for sharing this experience with us and glad to hear you're doing better.
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby HarryZ » Thu Nov 16, 2006 6:05 pm

Having followed the Tysabri patient experiences at several MS sites, I've also been surprised at the number and variety of miscellaneous side effects that patients are reporting. I thought that a lack of side effects was one of the main selling points of T.


The side effects that are taking place now took place during the trials but were not emphasized in the press releases from Biogen. These events were summarized as "adverse events" and took a back seat to the statistical benefits that Biogen stated. On some other MS forums that I read, there were Tysabri patients who reported some of these events from other patients that were getting the infusions at the same clinic.

Please don't forget that Tysabri is a very powerful drug that tampers with the immune system. We all know that people react differently to the various drugs that are out there and this drug is no exception. But due to the very nature of a monoclonal antibody, the patient must be monitored very carefully.

Harry
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Postby Loobie » Thu Nov 16, 2006 7:47 pm

Ronnie,

That really sounds like no fun at all. Even psychologically it must be a huge feeling of let down. I don't mean come off as cryptic but I am getting ready to do a trial and I can almost relate as I have a lot of hopes riding on the success of this potentially new drug. Good luck with that and I really hope that the pre-medications work for you and you see good results long term. Have a good one.

Lew
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Getting the blood test

Postby Ronnie » Fri Nov 17, 2006 7:50 am

Dear folks:
My doctor decided to get me a blood test to see if I have developed antibodies to Tysabri. I am waiting for the call from a lab, which will set up a home visit for a blood draw, and then it will take about four to six weeks for results. The information which the nurse gave me about this procedure assures me that I can pay 20% up front, the lab will bill the insurance, and if the insurance pays more than 80% I will get a refund, if they pay less, I don't have to cover it. Great. But how much does it cost?

I don't think I will ever have another Tysabri infusion. When I called on Wednesday to confer with Don (infusion specialist), he said that I was one of TWO people who had that reaction to the Tysabri under his care. Since two days earlier I was the ONLY one who had had the reaction, I think they hadn't anticipated this and weren't settled on what to do yet. Now they see this is not an isolated anomaly.

I trust these people and I don't blame them for trying to decide on the fly what they should do. I am glad they aren't planning to try the infusion on me again until they have the results of the blood test. I am reasonably certain that I am now allergic to Tysabri. I won't be getting it again. Nobody wants to say it directly, so I will.

Is this a tragedy? Well, it's not the Titanic.
I am still here, and I am still pretty resourceful.
Take care,
Ronnie
(you know, another Emoticon which would be quite useful would be "philosophically stoic")
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Postby Melody » Fri Nov 17, 2006 11:16 am

I have a feeling you have made a very wise decision. They say MS won't kill you but I can assure you anaphylactic shock can.
John was diagnosed Jan 2005. On lipitor 20mg .On Copaxone since July 4,2005. Vitamin D3 2000iu-4000iu (depending on sunshine months)June 10 2005(RX::Dr. O'Connor) Omega 3 as well Turmeric since April 2005. Q10 60mg. 1500mg liquid Glucosamine Nov 2005.
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Postby ewizabeth » Fri Nov 17, 2006 11:25 am

Ronnie,

Thanks for sharing your experience. How frightening! I'm glad to see you've decided not to take another infusion. For that to happen to two people at one site so closely together is scary too.

This is one treatment I've been thinking about, in case I don't get into the Tovaxin trial. Maybe Copaxone will have to suffice if I don't get into the trial.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Blood test...

Postby Ronnie » Fri Nov 17, 2006 3:14 pm

Dear friends:
I got the call and set up the blood test for Wednesday morning. I have to call them when I get a package in the mail, because that has to be here before they can do anything, but I am certain it will be here by then.

When all the dust has settled, and when everybody knows what is happening, perhaps the safety and efficacy of Tysabri will be acceptable, perhaps. They will have to explain this to me with graphs, however.

I will be keeping in touch!
Ronnie
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Postby euphoniaa » Sun Nov 19, 2006 2:45 am

HarryZ wrote:
Having followed the Tysabri patient experiences at several MS sites, I've also been surprised at the number and variety of miscellaneous side effects that patients are reporting. I thought that a lack of side effects was one of the main selling points of T.


The side effects that are taking place now took place during the trials but were not emphasized in the press releases from Biogen. These events were summarized as "adverse events" and took a back seat to the statistical benefits that Biogen stated. On some other MS forums that I read, there were Tysabri patients who reported some of these events from other patients that were getting the infusions at the same clinic.

Please don't forget that Tysabri is a very powerful drug that tampers with the immune system. We all know that people react differently to the various drugs that are out there and this drug is no exception. But due to the very nature of a monoclonal antibody, the patient must be monitored very carefully.

Harry


At the risk of being accused of being as negative as Harry, :) I'm posting another quote from the Tysabri prescribing information on their website:


"The long-term immunogenicity of TYSABRI® and the effects of low to moderate levels of antibody to natalizumab are unknown. Experience with other monoclonal antibodies suggests that patients who receive therapeutic antibodies after an extended period without treatment may be at higher risk of hypersensitivity reactions than patients who received regularly scheduled treatment. It is not known if this will occur with TYSABRI (see WARNINGS, Hypersensitivity and ADVERSE REACTIONS, Infusion-related Reactions)."

And another quote here:
"Observe patients during the infusion and for 1 hour after the infusion is complete. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity-type reaction (see WARNINGS, Hypersensitivity)."



With all the warnings and required protocols, I'm wondering why so many of the medical professionals involved in the infusions don't seem to have read and/or followed any of the literature.

You can read it here, in both the "Patient Medication Guide" and the "Product Information": http://www.tysabri.com/product-information.html

I find it deeply disturbing that so many MS patients are reporting around the internet that they're all set up to be infused with Benadryl along with Tysabri at their next infusion to ward off "another" allergic reaction.

I repeat -- anaphylaxis is a serious issue.

You know, every one of us is hoping Tysabri turns out to be the answer for as many patients as possible. I've tried not to put a damper on the enthusiasm despite my occasional misgivings. But right now I'm feeling pangs of guilt because I talked myself out of warning a friend about the problems in patients who stopped T and then started again. :(
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Postby HarryZ » Sun Nov 19, 2006 7:30 am

At the risk of being accused of being as negative as Harry, :) I'm posting another quote from the Tysabri prescribing information on their website:


Accused of being negative because you caution potential Tysabri users about the possible dangers of using this drug....nah...nobody would do that on this forum, would they? :)

With all the warnings and required protocols, I'm wondering why so many of the medical professionals involved in the infusions don't seem to have read and/or followed any of the literature.


Don't be surprised at this happening at all....like any profession, there are "good" doctors and "not so good" doctors. Those who are involved in the constant treatment of MS patients and force themselves to keep up with the latest information, are far more likely to be aware of all these potential risks.

I find it deeply disturbing that so many MS patients are reporting around the internet that they're all set up to be infused with Benadryl along with Tysabri at their next infusion to ward off "another" allergic reaction.


Amazing, isn't it !!! But you only have to look at how Tysabri has been presented to the world of MS medicine....the wonder drug that is vastly superior to anything that has been used to date. While Tysabri appears to have more efficacy than the CRABs, it's use comes with far greater risk than the CRABs ever had but this risk has been down-played by Biogen from the beginning. I guess I ask the question if we are now beginning to see this risk surface or is it simply a few "bumps" along the road as the drug now becomes available to the general public.

You know, every one of us is hoping Tysabri turns out to be the answer for as many patients as possible. I've tried not to put a damper on the enthusiasm despite my occasional misgivings. But right now I'm feeling pangs of guilt because I talked myself out of warning a friend about the problems in patients who stopped T and then started again. :(


Some people would suggest that by warning your friend of these possible problems, you are being negative and anti-Tysabri while in fact, you are simply providing factual information to your friend so he/she can be better informed.

Harry
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Postby ewizabeth » Sun Nov 19, 2006 7:52 am

HarryZ wrote:Some people would suggest that by warning your friend of these possible problems, you are being negative and anti-Tysabri while in fact, you are simply providing factual information to your friend so he/she can be better informed.



Amen to that Harry Z! At times I have felt as though when I try to talk about the possible risks of Tysabri, that I should just put a lid on it because the patient is hopeful and I am dashing those hopes. Now I think about it as a possible treatment for me, and I still talk about the risks.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby HarryZ » Sun Nov 19, 2006 8:07 am

Ewizabeth,

Amen to that Harry Z! At times I have felt as though when I try to talk about the possible risks of Tysabri, that I should just put a lid on it because the patient is hopeful and I am dashing those hopes. Now I think about it as a possible treatment for me, and I still talk about the risks.


Don't confuse "dashing one's hopes" and providing relevant information to a Tysabri patient. Some people would suggest you hold back this kind of info and keep the patient in the "dark".....in other words, what they don't know won't hurt them! Well, in this case it just may very well hurt them and seriously!

Take care.

Harry
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Postby OddDuck » Sun Nov 19, 2006 8:24 am

Hi, Harry and Ewizabeth! Well, as Harry knows (and you will, too, Ewizabeth if you go back and read some of our prior "warning" posts on here back in 2004 - or was it 2005 - about Tysabri), all I can say is "Amen!" to both of your sentiments here.

All I can do now is sit back helplessly and watch it all unfold with regard to Tysabri............whatever "it" ends up to be. :?

Deb
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