I think Sho is the only one on the forum to have received this in trial.
My neuro offered it to me yesterday. I have the literature and just watched the pod-cast on MS society website. My neuro explained it pretty similar to the podcast. The med binds to receptors in the body and prevents lymphocytes from leaving the lymph nodes. As if it imprisons them there. Keeps them in the peripheral CNS.
He described that there can be immune system changes. Chance of infection and the one that keeps flashing in my memory is herpes. It can also cause macular adema. It's a once a day pill which is the upside of it all. When initially started you will be monitored for 6 hours because there is a chance of a slowing heart rate. Also some metabolic panels will drawn to establish a baseline, before starting, etc.
Not too bad right? It's not as if the CRABs and Tysabri don't come with their own "what ifs." So, just wondering who else had been offered the med. I'm not planning on leaving my old faithful just yet. Gilenya is just the 1st med as you know already know in this whole new wave of pill form disease modifiers with varying positives and negatives to weight out. But, it's good to have options.
Lu, he's a regular neuro. I do think he understands, but isn't concerned.
Figures if there is a problem, just stop the meds. And, that others a yr out ahead of FDA approval on it will have problems 1st. The unapproved meds in the hopper I'm not so sure he'd feel the same about.
He's definitely not involved in the R&D of DMDs. That is evident. We speak more science behind the mechanisms than he does.
My oral drug trial ACT 128800 is supposed to be very similar to fingolimod and all the listed side effects identical. I started the drug trial just over 2 weeks ago and do not know if I am on the drug but have been keeping a journal for anyone who wants a little more info.
My gut feeling is that I am but time will tell!
I shall also be very interested to hear if and when anyone goes on fingolimod (gilenya) so keep us posted everyone.
"CMSC President's Statement on Approval of Gilenya
September 22, 2010 - Gilenya was approved on September 22, 2010 as a new, first line agent for RRMS. This is an important advance in the spectrum of MS treatments because it is a potent, oral agent with a novel mechanism of treatment. Further, the monitoring recommendations of the FDA are relatively easy to fulfill although the recommendation to observe patients for 6 hours following administration of the first dose may be problematic for some providers. Novartis has promised to support the use of this treatment vigorously and plans to implement services by October 4th, when the drug can be prescribed.
The propensity to use Gilenya will vary among physicians. While there are many potential side effects due to the presence of S-1-P receptors throughout many organs, these issues are manageable. The provider will need to be aware of which cardiac drugs may add to the potential bradycardia Gilenya induces, and have knowledge of symptoms related to increased pulmonary resistance and macula edema.
The long term consequences of sequestration of immature lymphocytes and internalization of S-1-P receptors in other organs are unknown. This situation is reason for caution in prescribing the drug, especially to patients who are doing well or who have other treatment choices.
Certainly, some patients with limited options should be given this agent as soon as it is available, however, patients with relatively stable disease or those who are candidates for treatments with better defined and mild toxicities should take a “wait and see” attitude until the initial group of patients for whom the drug is their best option have been treated for 12 to 18 months.
Michael Kaufman, MD
President, Consortium of MS Centers"
I've read all the posts and the interesting article that Lu posted. I think we'll be talking about this for awhile.
My neuro has been mentioning the oral drug at every visit for at least the past year. I talked to him a few months ago and he said when it is available for prescribing he will write scripts on a case-by-case basis. He did not think at the time I'd be a good candidate because my blood work tends to a low white count already, but retest bloods and ekg and make a decision.
I have made my decision though. As much as I'd like to stop the injections, I am going to stay with them for now. I read that the side effects are manageable, but I really don't want to add more side effects from a drug to what I already have to deal with.
So, I will keep things status quo yet be very interested and excited to hear the experiences of those who do decide to start taking it
Lu - That write up provides good food for thought.
Julie - I'm pretty sure I'm sticking to current treatment too. Like you, I look forward to hearing experiences with it though as time goes on. Maybe some people on the www will find our convo here one day and pop in to tell us - That would be awesome!
yeah, I figure if the president of the MS consortium isn't hot for this drug, it might be wise for all of us to take our time moving to the orals.
There was another oral med that they presented at ECTRIMS that had a ridiculously high rate - 96% - of controlling relapses in Phase II studies. They think it might be on the market by 2015 (I think that's what they said). The drug is Ocrelizumab and you can read more about it and other recently announced results at
My MS Specialist is involved in the trials. Like anything he does thing patient by patient. He wanted me in the trial he is doing for Gilenya and PPMS but my MRIs stay the same and they want to see changes.
The thing is they do not know the risks yet. He says the injectables are very safe so for most people he will stick with the injectables. The injectables are only 35% effective. The better a drug works the more it surpresses the immune system and the more risks you have.
They took the lowest dose they studied to the FDA so there must have been more problems with the higher dose. There were two deaths on the lower doses from a herpes virus. The low dose has the risk of Shingles and MSers are not a candidate for the Shingles vaccine since it is a live vaccine. I for one do not to risk reoccurring Shingles.
I am not a candidate for any treatment for slowing progression out today. I do not know if I will take the orals at this point if offered. Having MS documented since early childhood I feel A. the progression is slow and B. a lot of damage is already done.
I do not think insurance companies will be eager to pay for orals when the DMDs are known to be safe, effective, and are CHEAPER!
What everybody said seems right. Gilenya is stronger than the current DMDs, but also more dangerous. The main groups of people who ought to consider it are
* People who have trouble with the current DMDs, either with injecting or with the side effects
* People who aren't being helped by the current DMDs. If you current med doesn't seem to be helping, that might be a good reason to try Gilenya. The biggest reason I went in the trial was because I don't have a lot of inflammatory activity or obvious relapses so the neuro didn't think the regular DMDs were all that likely to help me. Gilenya is thought to have some neuroprotective effects even outside its effects on the immune system.
FWIW, I had no discernible side effects in the 18 months I was on the drug and the two people who died in the trial were on a higher dose than the one the FDA approved. They found that the lower dose was just as effective and less dangerous.
Ess, Meg, Sho... So, sounds like the concensus of recommendations by docs to our members so far is if current treatment is working it's not being considered (except for my doc, lol - what's up w/that!)
And, Alex brings up an excellent point that the more the immune system is modified, suppressed, etc. the higher risk of complications come in to play. Though it sounds super promising for those who need stronger meds due to their course of MS.
Sho thanks for reinforcing this with info provided - you are are resident user expert on this! Would you consider going on it full time?
No, I don't think I'll go back on it now that I'd have to pay the big bucks. I'm going to wait for one of the other ones. The Gilenya didn't seem to do anything to stop my progression. It's so hard to assess effectiveness in MS treatments, though. That's why they rely so much on statistical analysis. "When somebody finds an effective treatment for MS, you’ll know it without the need for sophisticated statistical calculations." (George Schumacher in http://content.karger.com/produktedb/produkte.asp?typ=pdf&file=000151525). Plus the benefits seem to be very unevenly distributed. See http://fty720.blogspot.com/ for an example of someone who seems to have been helped (the older posts have more substance). In the meantime we just muddle along as best we can.
I was in the study and in the extended study. Frequency of cold sores went up while on the drug, but otherwise I sing it's praise. No relapses, decrease in my symptom severity @ the end of a stressful day, and what I would definately call a major improvement in my day to day efficiency. Novartis is offering an assistance program. If what you are on works, by all means stay on it, but if not, I would definately push to try it.
Hi there! Thanks for popping in. If you dont' mind me asking, how were your relapses prior to taking starting? And were you on another DMD prior? (I can't remember the criteria - sorry). And, are you on anything now? (sorry for all the questioning)
Glad to have you join us and look forward to hearing more.
We just sold our home and didnt think it would sell so fast.. been scrabling to find a home to move into. Anyhow. I got lucky and was put in the study within 4 months of being diagnosed. I have never been on any other DMD. My Dr. ( MS specialist @ Duke) quickly figured I was on the drug and not the placebo due to the side effect of cold sore frequency going through the roof ( once a yr prior to going on the study to once every 2 months) If thats correct ( it is a blind study so we will never 100% know ) I have been on fingolimod for 2+ years now. they did end the trial a few months back and put me on the extended study where I was definately on the drug. WE just learned the trial was being ended as Gilenya was approved Oct 4th. My last visit is in Jan. I have already been contacted by Novartis for the assistance program and they ARE picking up 100% of my copay.
as far as relapses. I have had none. I was Diagnosed after my second lesion presented. Large lesion in the T region of my spine. I went numb from the waist down over a period of 3 days. On a daily basis I usually would have numbness in my feet and patchy tingleing in my legs. after about 6 months of being in the study. These symptoms started residing, and as of today, I rarely get any numbness or tingling at all.
Not sure if that answered your question, but will be happy to supply any info I have to y'all.
Thank you, will try to keep everyone informed of my dealings with Novartis. I am getting some special treatment since I was in the trials.
Speaking of running, am happy to announce that I ran my first half marathon in October at the Denver Rock and Roll Half Marathon. My girlfriend at the time I was diagnosed ( who is my wife now by the way... bless her) told me she wasnt going to let me go down with out a fight. I am Running Richmond on the 14th if anyone else is going to be there.
Sorry that I missed this discussion the first time. The baby will be full term on the 14th of Deember, and due jan4. I have been trying to get MS out of my mind so that I could focus on the happy things.
I think that I am going to try the drug. The only problem, is that I have a history with staph infections of the skin. I am allergic to topical antibiotics, so I will definately have to be proactive with any cuts or such.
I was on Betaseron, and both my local Neuro and my MS doc thought that I needed to try something else after the baby. My local guy is an optho-neuro by trainig, but he has the most experience with MS in our region. He said that he wanted to change my meds last winter when I went off of the DMD to get preg-o.
I am 36 an in rather good helath. I don't think that the slowing of my heart rate will be much trouble because my resting rate is a little on the high side anyway. I will keep you all posted.
I'm in the trial for fingolimod in sweden (stage 4 trial), I've been taking fingolimod for a month, and so far I've not been experiencing any side effects apart from a bit slower heart rate. And I must say it's almost heaven to not take injections every other day :-)
I'm in a big predicament. I was diagnosed with MS about 4 years ago and Have been taking Avonex. I've done very well with no episodes. We have been talking about the Gilenya and finally decided to give it a shot. So my Dr. tells me to DC the Avonex. Well the gilenya is covered under my insurance but the the problem is they denied authorization. My Dr has yet to appeal. I'm getting a little upset. I call the office and his assistants tell me it is still sitting on his desk. They told me me just wait till they get back and basically they been very short handed. So here I off my medication for over a month now and debating maybe I should change doctors. I have a very mild case of MS. My lessions have actually decreased and are very faint. The isurance company want me to fall two medications before authorizing the Gilenya. I really don't get it I really wanted to try this pill. Is there any thing else I can do?
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