Ugh, Gilenya death after first dose

[ActiveMSers]

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

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

[TJ1]

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?

[robyn]

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.

[Stella]

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.

[Marinadca]

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

[TJ1]

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

[Marinadca]

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?)

[garyp]

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.

[stevema55]

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.

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

[MSSpouse]

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

[stevema55]

This is old news!! I started Gilenya in October of 2011. I had to goto my Doctors office first thing in the morning(which in St. Vincent's Hospital Worcester,Ma.). I took my first Gilenya capsule at 9am and and stayed in a exam room where a nurse came in every 20minutes to take my blood pressure and heartrate. I'm glad the hospital has free Wi-Fi because I brought my laptop and watched Movies on Netflix the whole time.
At 4P.M.(6hours after taking the first Gilenya capsule) the nurse said they do not notice and flucuations in either my heartrate or blood pressure and I could go home. They said to take one capsule at the same time every day.
Over the past 4months I've had regular heartrate and bloodpressure testing and they have both stayed stable.
The issue of a rapid decrease in heartrate and BP has been known since the trials. My Doctor followed All Manufacturers protocols when starting me on Gilenya and has seen none of the side effects.

[MSSpouse]

Stevema55,
Just to clarify, are you saying that you were hooked up to an ECG continuously for the six hours following taking the drug (and a bit before), in addition to the regular bp and heart rate monitoring? That's what this EU recommendation was calling for, and what some have apparently been surprised by. Your description and other ones I have heard about taking Gilenya in the U.S. haven't explicitly mentioned the continuous ECG. I have not directly observed anyone being treated with Gilenya. So sorry if I, and apparently this article, misunderstood.

This is old news!! I started Gilenya in October of 2011. I had to goto my Doctors office first thing in the morning(which in St. Vincent's Hospital Worcester,Ma.). I took my first Gilenya capsule at 9am and and stayed in a exam room where a nurse came in every 20minutes to take my blood pressure and heartrate. I'm glad the hospital has free Wi-Fi because I brought my laptop and watched Movies on Netflix the whole time.
At 4P.M.(6hours after taking the first Gilenya capsule) the nurse said they do not notice and flucuations in either my heartrate or blood pressure and I could go home. They said to take one capsule at the same time every day.
Over the past 4months I've had regular heartrate and bloodpressure testing and they have both stayed stable.
The issue of a rapid decrease in heartrate and BP has been known since the trials. My Doctor followed All Manufacturers protocols when starting me on Gilenya and has seen none of the side effects.

[stevema55]

No, I was not attached to a EKG during the 6hour period of my first Gilenya capsule.
I had a EKG aweek before, and a EEG(My Doctor was testing of signs of Epilipsy). He also did blood tests one test was to see if I had had the Chicken-pox virus.
I don't understand what your so worried about, unless you have issues with you heart?
For me it was a breeze, like taking a M&M chocolate and sitting around for 6 hours watching Netflix movies on my Laptop. The time went by so quick it felt like I was there for an hour. The nurse said my heartrate only fluctuated 5beats per minute thru the 60 hours. What there looking for is a drop from my 75BPM down to 50BPM.
I'm so glad I switched. NO MORE NEEDLES!!! I hate needles, especially giving them to myself. Now it's just another pill I take each morning and like I said I had no enhancing lessions in a 6month period.
As far as breathing or running is concerned, I'm not one to ask. Besides MS and ahandful of other issues I also walk with a cane, have COPD and Asthma.
I really don't think a EKG is nessasary in the doctors office as I never felt any chest pains, light headisness, or signs of heart issues.

[MSSpouse]

stevema55,
Thank you for clarifying. The point of the article is that EU medical authorities are recommending continuous ECG monitoring for six hours after taking the first Gilenya dose. That's the part that's 'new' news.

I think you may be misunderstanding the reason for my post. It had nothing to do with any fear of Gilenya, which appears to be a promising drug. It was just meant to share a news update about this drug which, as indicated by the title of this thread, has been the subject of some controversy and concern. Hope someone found it helpful, or at least just interesting!

[stevema55]

I understand what your saying and I'm not a doctor, but my opinion is that it's not needed.
The original was in the final trials when they were using 100MG one persons heartrate dropped and they died. I think I heard that another person died afew months ago, but I believe they had heart problems.
I guess that to be safe the manufacturer my be suggesting to add the EKG test to the 6hour monitoring protocol.

Best Regards,
Steve