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Old 12-14-2011, 07:21 PM
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Default Ugh, Gilenya death after first dose

This was reported in The Wall Street Journal Monday. There are always risks with new meds. Here is my original blog on the topic of new oral drugs (Beware the Piranha). It's important to note, though, that Gilenya has been pretty safe early on. http://00634ca.netsolhost.com/blog/?p=61

Quote:
ZURICH (Dow Jones)--The sudden death of a 59-year-old patient in the U.S. who died after the first-time use of Novartis AG's (NVS) multiple-sclerosis pill Gilenya is raising questions over the drug's safety even as the novel medicine, which was approved a year ago, has generally been well tolerated by thousand of patients.

Novartis said a patient, who had received the first dose of Gilenya on November 22, died a day later. The person, Novartis said, had successfully completed six hours of post-dose observation without incident. Because Gilenya can slow the heart rate of patients, heart monitoring in a doctor's office is recommended.

The patient, whose identity wasn't revealed, had suffered for about a decade from multiple sclerosis, an autoimmune illness that affects the brain and spinal cord. Gilenya was approved in 2010. At the time, experts said that while the safety profile of the drug is acceptable, patients need to be aware that the drug can lower the heart rate, provoke a small decline in lung function and cause eye problems.

http://online.wsj.com/article/BT-CO-...13-709910.html
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  #2  
Old 12-15-2011, 11:02 AM
TJ1 TJ1 is offline
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Default Q on Gilenya use

RIP to the deceased.

Does anyone here take Gilenya?

If I were to go on any DMD, that's the one I'm most "open" to -- but am wary of the effects that some say it has on your ability to exercise, how it leaves you winded, etc.

Yes, I know with MS such concerns are relative, but that (Gilenya's reported potential effects on heartrate, etc.) is what is keeping me at bay...

What do people here think?

Anyone take Gilenya? What's your verdict?

Last edited by TJ1; 12-15-2011 at 11:05 AM. Reason: typo
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  #3  
Old 01-02-2012, 07:39 AM
robyn robyn is offline
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Default Gilenya

Hey, my neuro wants me to think about changing if my next mri shows more lesions but I'm scared. Some of the side effects are horrific. After a rough start the old Avonex dosen't seem so bad after all.
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  #4  
Old 01-02-2012, 09:52 AM
Stella Stella is offline
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Don't blame you Robyn, I would be scared too! Although a pill as opposed to an injection sounds a heck of a lot better, I would feel better with a longer tested drug with good results. The heart side effects scare me.
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Old 01-05-2012, 10:08 AM
Marinadca Marinadca is offline
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Default

I have been taking Gilenya since November 2010. I have noticed that I can't get my heart rate as high as I should be able to...but it doesn't really stop me.

As for side effects... I did have the initial lowering of the heart rate during the first 6 hours, but it recovered before I had left the office. Aside from that I have not seen any side effects.

I love it and plan to stay on it as long as possible. My 1 year MRI showed no new activity, and some improvement. I was on copaxone for the first year and had both relapses and more lesions.

I think new drugs can freak people out, and immune suppresents/modifiers are especially scary. For me it is so worth the risk, Copaxpne was ruining my quality of life and I am so much more happy and active on the pill. But for others they may be doing well on their current therapy and tolerating it well. If you have something that works for you, don't fix what's not broken
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  #6  
Old 01-05-2012, 01:06 PM
TJ1 TJ1 is offline
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Default Gilenya/Heartrate

Thanks... and a question:

When you say you can't get your heartrate as high as it should be, do you mean that you are not able to exert yourself as much as you could in the past? i.e., For example, can't run as far, run out of breath faster, etc?

Just trying to understand "what it's like" on Gilenya, as regards physical exercise...

If others have thoughts, would appreicate your thoughts, too. Thanks
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  #7  
Old 01-06-2012, 09:41 AM
Marinadca Marinadca is offline
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Default

At first it was that I would get winded/out of breath a little quicker.

But the longer it has been and the more I have grown my fitness level it has really diminished.

Even when I first noticed it the difference was only appreciable because I was using a HRM.

So, say my max heart rate before was 175....now its 170. Not a huge deal for me....but something interesting to note. I didn't notice it in everyday life at all...more like at mile 10+ on a bike ride.

I know there was another member here who is way more knowledgeable about it (Pawpaw?)
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  #8  
Old 01-18-2012, 11:52 PM
garyp garyp is offline
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Default My experience with Gilenya

Like others who have started in Gilenya...I too got more easily winded, particularly when playing indoor soccer.

However...as the months wear on, that effect has reduced. I actually ran a half marathon a couple of weeks ago with no problem, and the problem is reduced when playing indoor soccer. I think that within a few more months the effect will reduce even further.

I did my own home based V02 max test prior to starting Gilenya - during that I recorded a max heart rate of 140. In the couple of months after starting Gilenya, max heart rate would not go above 120. In the past few months though, am getting up to 130 now. So..in a few months I think it will improve some more.

Every pharmaceutical drug has risks. You have to weigh the benefits against the risks. This second generation of drugs (Tysabri and now Gilenya) have double the effectiveness of first generation drugs (Avonex, Copaxone, Betaseron and Rebif), but they do come with increased risks. The key is to be highly aware of your body while on these drugs - and if any of the side effects happen notify your neuro and take action straight away. And don't forget....the % of people experiencing severe side effects is very small. You have to trade off the risk of severe disability vs. the risk of a severe side effect. That is a different calculation for everyone I know. For me...I take the risk. I have had MS for getting on for 17 years now and can still play indoor soccer, ran a half marathon a few weeks ago, hiked to Everest Base Camp last year. Does taking these drugs guarantee you a similar outcome? No...but it does shift the probability in your favor.
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  #9  
Old 01-21-2012, 09:51 PM
stevema55 stevema55 is offline
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Default Gilenya

What's it like? Well I've been on Gilenya now for over 4months and I don't notice a thing. Be it that I am not that active because I walk with a cane because of balance issues, but I can walk on a treadmill for 20minutes with no problem. I also had an MRI 4months after starting Gilenya and I had no new Lesions. I did contract Bells Palsy on Dec. 27th, but My Neurologist and PCP both believe it has nothing to do with Gilenya or my MS. I've had the Bells Palsy for almost a month now and it has been getting much better in the past few days.
I would have no concerns about switching you Gilenya just get a baseline MRI before you start it and another one 3 to 6months after you start it. I was on Copaxone and got new lesions and got Drop-Foot. My Neurologist switched me to Rebif and had to live with the common side effects, the medicine hurt bad for about 15seconds because Rebif is not PH neutral and the Flu symtoms. I also was put on Ampyra which solved my Drop-foot after not being able to move my left foot and toes for over two years. Now I and move my toes and foot, It just feels numb.
It's so GREAT on Gilyena!!! NO NEEDLES, NO side effects!!! I feel like a normal human being. You just have to take your first pill in your doctors office and have your heart rate monitored every 20minutes for 6hours. I brought my laptop and watched Netflix the whole time(LOL). They told me my heart deviated 5beats per minutes which is nothing. They look for someone who starts with a heart rate of 70 going down to 50.
Your doctor will probably test to see that you have had chicken pox and are not prone for seizures, along with testing your blood.

Quote:
Originally Posted by TJ1 View Post
Thanks... and a question:

When you say you can't get your heartrate as high as it should be, do you mean that you are not able to exert yourself as much as you could in the past? i.e., For example, can't run as far, run out of breath faster, etc?

Just trying to understand "what it's like" on Gilenya, as regards physical exercise...

If others have thoughts, would appreicate your thoughts, too. Thanks
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  #10  
Old 01-23-2012, 06:23 PM
MSSpouse MSSpouse is offline
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Default More news on Gilenya

News from Reuters late last week:

EU says Novartis MS drug needs heart monitoring
...
This should include electrocardiogram (ECG) monitoring (my emphasis) before treatment and then continuously for the first six hours afterwards, as well as measurement of blood pressure and heart rate every hour.

Mark Schoenebaum, an analyst at ISI Group, said the call for active ECG monitoring was very different from the U.S. Food and Drug Administration (FDA) recommendation of observation and could encourage European doctors to use Biogen Idec's experimental BG-12.
...
Thoughts?

You can read more here:
http://uk.reuters.com/article/2012/0...80J15X20120120
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