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Gilenya approved
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I am sooo excited!!!! Here is the link from the Novaritis site. http://www.novartis.com/newsroom/med.../1445917.shtml
CrazyCatLady
MS Does Not Define Me.....My Love of Tea Does! LOL!
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Biogen had a little something to say :
http://www.businesswire.com/news/hom...lenya%E2%84%A2
As far as Gilenya being an immunosuppressant or modulater, I'm seeing conflicting info. The majority of what I read says suppressant. Even Novartis' info says that the drug lowers the number of lymphocytes in the blood and puts the patient at a greater risk for serious infections. If you read further, it gives basically the same protocol in regards to the chicken pox virus/vaccine as is recommended for "immunosuppressive therapies".
I know I was asked about chicken pox before starting Ty and not Rebif of Copaxone. That alone raises a flag for me. Not that I wouldn't try Gilenya, I'll just as Wkikta says, think long and hard about it. The list of side effects seems pretty serious. I know becuse it's listed, it doen't mean I'd get any of them. Just that it's something to think about.
It's great we have another option now and one that doesn't require injections.
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Love Tysabri but not Biogen
[QUOTE=MrsBones;1252193]Biogen had a little something to say :
http://www.businesswire.com/news/hom...lenya%E2%84%A2
That press release is so self-serving. My DH has had innumerable problems with Biogen and the Touch program, and they are shameless with their pricing. My DH has great results with Tysabri, but we have no respect for Biogen.Chomsky Chick
This floating world is but a phantasm.
It is a momentary smoke.— Zen monk
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Gilenya does a suppression of the "T" cells in the lymph nodes. It doesn't completely suppress the immune system but because it's altering it you are more susceptible to infections. The 2 deaths during clinical were people that had the herpes virus and the autoimmune system could not stop it from spreading throughout the body/brain.
I received blood tests checking for my herpes count and if I had the appropriate immunity to chicken pox etc. I have to advise my Dr office if I come in contact with anyone that has chicken pox or even cold sores that I could have come into contact with. These are things I know from my clinical, personally I am just too broke to be on the copaxone. Just like any DMD I think if it's working why switch??! I am still uncertain if I am placebo or the actual med. I was asked to complete the phase III core study which ends in January prior switching to the extension phase. I am going to see through my commitment but mostly because my contract indicates that they pay for 2 years of meds if the FDA approved.
We are getting more options and it's exciting. I don't know the medical positives or negatives around the Gilenya but I do know that those in clinical that have been on the actual drug have had great success thus far. All medications have side effects and possible things that can lead to death... have you ever read the warnings on an advil bottle?
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Agree Day11, the warnings for Gilenya look very similar to those for the CRAB meds, or for aspirin or penicillin. Any drug strong enough to work to treat a disease is going to be strong enough to cause side effects.
I went to the Novartis website and read through the "Prescribing Information." It is not light reading (!) but it tells it like it is. Looks to me like the two patients who died of disseminated herpes were on IVSM at the same time, also an immune suppressant, and there are warnings that two immune suppressants (or moderators) don't mix well. Most of the side effects listed are rare, not much different from placebo, resolve when the medication is discontinued, or they occur in people who had warning signs their could be a problem (they already had heart problems/EKG changes, or were known to have liver problems).
I have a neuro appointment on October 4, and will want to hear what he thinks now that Gilenya has been approved. He was involved with the clinical trials, and has already told me he thinks it would be a good option for me.
As always, each of us is different and we have to make individual decisions. I'm just glad there is now an oral option
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Originally posted by Day11 View Post
I was asked to complete the phase III core study which ends in January prior switching to the extension phase. I am going to see through my commitment but mostly because my contract indicates that they pay for 2 years of meds if the FDA approved.
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