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FTY720 - Fingolimod - Gilenia - you know the 1st MS pill...
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AMLYGE posted:
Some of you may have already heard me talk about his but unfortunately other MS therapies have not worked for my ... Rebif quit working and I'm allergic to Tysabri...

I've been off medication since the end of July waiting for the release of this drug... however please understand that I am in no way a PROMOTER of switching drugs if you have something that is working for you ... BUT...

This Pill is supposed to be signed off on my the FDA on Tuesday... I am going to consider it a new "holiday" in my book :)

After that just have to wait for it to be available on the market.. (tick toc tick toc)... Anyone have experience with taking a newly released drug and how long until it was available???

Just thought I'd share the news for those of you who haven't already read it :)

(God, please let this drug work for me)
Amanda
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chelylynne responded:
Thanks! I'm just now debating stopping my therapy ..so I'm trying to hang on..hoping this will help. I used to be a drug rep..not for any ms meds...and it takes a while.

Several issues will arise...1. distribution..getting to the pharmacies..which will carry it? 2. Insurance coverage..sometimes can take up to a year for an insurer to put it on somewhere...(the formulary). and 3. ok..maybe my ms head can only think of 2 right now lol

waiting with you :)
MIchele
 
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chelylynne responded:
For what it's worth. I looked online and it said something to the effect of it's it's approved tomorrow..it should be December before it's available. Hoping it's sooner :)
 
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AMLYGE replied to chelylynne's response:
thanks.. I knew about the "sign off tomorrow" but I hope it will be available in December... Amprya came out pretty quick... wonder if the companies will try to start people on samples??? we'll wait and see.. I am soo excited bc even if i wasn't in line for this therapy today marks a MONUMENTAL MOMENT in MS therapy history!!! Very COOL!!!...thanks Michele!!!
 
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chelylynne replied to AMLYGE's response:
should we set our alarms for ms christmas???
 
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LadeeEmpress responded:
The longest piece will be getting insurance companies to cover the formulary...it maybe available in December but still not covered. Although if you can prove through documentation that none of the other therapies work for you...you maybe able to get it pushed through your insurance.
 
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AMLYGE replied to LadeeEmpress's response:
@ Michele yes we should hopefully they post something about it tomorrow...

@LadeeEmpress... Thank you for your advise!! And thankfully I already had to go through that fight with my move to Tysabri... so my Dr will be ready to help me fight! Thankfully my nuero and his staff are really good with helping to push things along :) I pray it happens quick b/c I am off drugs right now (which hopefully will help with that fight) and of course there is a little anxiety about what could happen with that....

Thanks for your support friends!
 
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LadeeEmpress replied to AMLYGE's response:
Looks like it got approved!! Congrats...
 
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candimari responded:
I am one of the study patients and have been taking this drug for 3 1/2 years. I enrolled in the study after trying Avonex (it gave me a constant fever) then Copaxone (bad site reactions, and had 2 times it got into my bloodstream too fast and I had a bad full body shock type reaction). FTY720 - Gilenya has has minimal side effects for me. I did have a lowering of the heart rate at first dosing, but otherwise minimal side effects. It would make me a little tired, so I started dosing at bedtime and have done fine. From the other patients I've run into, they have been very excited and have done well on this drug. I have had some small episodes, but I feel the drug helps to keep them from getting as bad as before. I had a recent MRI that showed little change since I started the drug. The study was very controlled. As this gets released into the general MS population I'm sure there will be pre-cautions and criteria the physicians will need to feel good about perscribing this drug. During the study I have been through tests to watch for macular edima, pulmonary tests, and blood tests. We each have to choose the best path for us for treatment. For me this has been the best one so far.
 
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carrieannerogers replied to candimari's response:
I have been taking Gilenia in a controlled study group for 2.5 years. At first I thought I was on placebo because, for the first time when I tried a MS medication, I had no side effects. My improvements came on very gradually, but after several months I started to notice that my symptoms were decreasing in both severity & duration. In the past year I have also begun to notice that the frequency of the worst of the symptoms has also been improving. It feels like a miracle! I'm really worried though, Candimari, about being able to continue to get the drug while the pharmacies/insurance companies work this out. Has your study rep been able to give you any information regarding what will happen if Novais stops providing the drug to study participants and we are unable to get it through other means?
 
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Neil S Lava, MD responded:
We are all excited that this medication has been approved by the FDA. It appears that the medication will be available much sooner than December. Perhaps in a few weeks.
This medication appears to be quite effective, but does have some risks since it does suppress the immune system.
Don't know cost yet, but will find out soon.
Those patients who are doing well on current therapy will probably stay on their therapies, but people who are not doing well now have another option.
 
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AMLYGE replied to Neil S Lava, MD's response:
WoW!! Thanks "carrieannerogers", "candimari" and Dr. Lava for the input... I have been on cloud nine for the past couple days... excieted and emotional all at the same time!

This is such great news for MSers weather the are switching or not!!! YIPEE!!!

and "carrieannerogers" the insurance coverage and assertiveness concerns me as well but being that it will be a "first-line treatment" we should have to jump through hoops like I did when I went from rebif to tysabri (my INS tried to deny tysabri b/c I hadn't tried everything else but my NUERO's team got that resolved quickly)

It was so wonderful to hear from 2 that were in the trial of the pill - your experience and advise is comforting!!!

Best wishes to you all!!!
Amanda

 
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wonkagirl replied to carrieannerogers's response:
Been in trial for 2 years. just had first dosing of Gilenia 2 weeks ago. At my appt today, I was told that Oct 4th it is going to be available. and that the end for being in the trial will be in approx. 3 months. Hoping I could afford to remain on this "miracle" drug
 
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AMLYGE replied to wonkagirl's response:
YaY! I was just at a MS presentation that my Nuero spoke at tonight!!! Gilenya is AVAILABLE!!!... of course after all the tests are done (eye appt, blood work, etc - or yeah and the 6hrs of first does monitoring)....

so now I need my Dr. to prescribe me some patience!!! :) I gonna call tomorrow to try to find out what I have to do to get on my new drug -- I have had 2 small attacks which include 2 rounds of steroid treatment in the past 2 months!!!

..and from the info I was reading this will be a "tier 3" or highest copay drug and depending on your ins. plan maybe your coinsurance too... Novartis is saying that they are going to help MSers with copay assistance and help with the testing required too

Amanda
 
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forbesy replied to Neil S Lava, MD's response:
Those participating in the controlled studies seem to be raving fans. Since Gilenya is an immune suppressant, and the other therapies are not, are you concerned about increased risks in comparison to the other drugs?


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