Fingolimod - MS oral therapy

femur61

Hi, does anyone know when it will be available in Ireland, it is on the Sky news website that it is now available in the UK. Apparantly it is more effective than beta interferon and no side effects.

ElleEm

Just saw that on the news myself. I hope I'm eligible when it comes to Ireland. I've been having terrible reactions from my Copaxone injections the last while.

byhookorbycrook

it does, like all drugs, have side effects. The ones that leap about at me are optical and liver function.

Gilenya Side Effects

The most common side effects associated with Gilenya include headache, flu, diarrhea, back pain, abnormal liver tests and a persistent cough. In Gilenya clinical trials, more serious side effects included:

• Bradycardia (slowing of the heartbeat) during the first Gilenya treatment. Consequently, the first does must be taken under medical supervision.
• Increase risk of serious infections due to a decrease in the number of white blood cells (lymphocytes) in the blood.
• Macular edema (swelling of the central portion of the retina) that causes distorted vision.
• Shortness of breath
• Liver problems may be indicated by nausea, vomiting, stomach pain, loss of appetite, fatigue, jaundice, dark urine
• Elevated blood pressure
• Bronchitis
• Diarrhea

bizmark

sounds wonderful

byhookorbycrook

Most of the MS drugs have pertty rotten side effects. Tysabri has a 1000 to 1 chance that you will get PML which can be fatal.

alpina

Have been on the whole cocktail of MS drugs, most recently two years of tysabri but no relief worth mentioning so am curious as to result/benefit/reactions, Neurologist mentioned September for Irish release, don't know how cut in stone this will be...
Here's hoping for something..:(

byhookorbycrook

Alpina, have you been relapsing on Tysabri?

alpina

byhookorbycrook wrote: »

Alpina, have you been relapsing on Tysabri?

Apologies for delay in responding, ya basically two years of tysabri & decided to pack it in. Possibly sounds a tad 'gung ho'/immature but it was not making any difference at all. Towards the end of treatment my neurologist agreed that it appears tysabri just came along too late...
Going on recent news; Gilenya™ Reduces Risk of MS Disability Progression Regardless of Treatment History
A new analysis demonstrated that Gilenya (fingolimod) reduced the risk of disability progression in people with relapsing-remitting multiple sclerosis (RRMS), regardless of treatment history it just may prove somewhat beneficial, may...

byhookorbycrook

"They" say : no progression on tysabri -= progress, if you get me.

alpina

Yes totally get what you are saying, in my situation one can say no news is good news, however things were going backwards while on it...& without going into detail online just before the two year mark it proved pretty obvious that being on tic tacs would be as benificial going on my situation then. Was actually wondering was I on a placebo at the time, but no they assured me I was not, guess VHI would not be too happy about being billed over 2K for a vial of saline now....

bnt

One important point regarding Gilenya / fingolimod side effects: they're dosage-dependent, and the dosage has been reduced through the trial process. Most reports don't take that in to account. In Phase II they tested 5mg and 1.25 mg, while in Phase III they tested 1.25mg and 0.5mg. The higher dosages have been dropped entirely, and only 0.5mg is being produced and prescribed. Novartis says they had no cases of melanoma or macular edema in patients on the lower dosage, and the liver effects don't sound (to me) worse than what you'd cause by drinking alcohol.

Meanwhile, the main competitor to fingolimod, cladibrine, is a goner: Merck has dropped all attempts to get it approved for RRMS. Quote:

Considering the time it would take to complete a new clinical trial program and the significant risk that even a new program would not result in data sufficient for Cladribine Tablets' approval, and taking into account the changing competitive landscape, we have decided to not pursue further the worldwide approval process of Cladribine Tablets and to focus resources on other projects bringing benefit to patients with multiple sclerosis.

(I'm not in the pharma business at all, I'm just keeping an eye on these therapies for the obvious personal reason.)

trishawisha

Sorry to bring up old thread. Went to my Neuro today and she said I can probably go on Gilenya when it comes out. Was so happy then just read about side effects above. She also said the Government have not released funding for it as yet but it is expected to go ahead soon. Anyone else have any news about it?

outnumbered82

I was told the same that they have no funding for it but once it comes out in the new year i'll be able to get it, you have to go in to the clinic for the first time you take it because your heart rate slows down!! They say that it has no side effects bar the slowing down of your heart. the only thing i would worry about it would be that they dont have much info on it.

LegacyUser

Hi there, any more updates on when Gilenia will be available in Ireland. Copaxone not working and afraid of Tysabri.

fergal.b

My wife is starting on it next thursday in Beaumont we have to spend the day there so she can be monitored, anyone else on it yet sounds promising.

byhookorbycrook

Hope it goes well for her, Fergal.

LegacyUser

Hi i wondered how your wife got on I did think funding had been released yet? My mum is on no medication at the moment and really hoping that it will be sorted out soon before she has a relapse as she can feel herself slipping

fergal.b

Hi Shivs85 I don't think the funding is released yet but the company are giving out what I think is called compassionate amounts of the drug to the four people starting on thursday. My wife was having very bad side effects from rebif and then avonex and had to be taken off it so I guess it was just luck "if I can call it that" that she was put forward for it.
I did hear that the funding should be there with in the next few months so hopefully your mum will get sorted soon.

Best wishes.





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femur61

http://health.yahoo.net/news/s/ap/novartis-drug-investigated-after-11-deaths

This is prob scaremongering but this has been just relised so let them know that you are aware of the latest updates.

I take betaferon and have been on it for 11 years no problems but also follow a very strict diet. There is a huge amount of infomation on the net if you are interested I can email you the websites. One is the Best Bet Diet which a group from the UK who follow a gluten, milk free diet and wheat free diet. Dermot O Connor is an Irish guy who wrote a book last year on alternative strategies for someone with MS

IM0

femur61 wrote: »

http://health.yahoo.net/news/s/ap/novartis-drug-investigated-after-11-deaths

This is prob scaremongering but this has been just relised so let them know that you are aware of the latest updates.

thats about the same number as tysabri, and its brand new! and tysabri has been around on and off for over a decade and is very strictly monitored and controlled now. Id say go with tysabri, its proven and tested and only a TINY TINY % of people develop the PML complications. this is all based on that article you liked to published on friday gone :eek:

fergal.b

Well we got the call today that the trial for thursday has now been put off till further notice

byhookorbycrook

Pity, but to be expected, I suppose.

hdunne

I'm hoping to get the tablet next month on compassionate grounds, is anyone else taking the tablet or have any experience?

byhookorbycrook

Was talking to my neuro, she says that the heart deaths were in people with heart problems to a greater extent and that there should be no reason for it not being made available(bar cost)

fergal.b

We are still waiting on word back.

bizmark

Is this dead in the water ? i was hopeing to be consider for this as iv had a horrible few months on rebif and i cant imagen avonex being any better for me considering its the same type of medicine have to say though the side effects and news about these pills and my experience with the injections are putting me off trying any of these so called treatments again

byhookorbycrook

Bizmark, have you considered tysabri?

bizmark

I have seems the only real option i have though once a month at the docs is both convenient and a giant pain in terms of going anywhere for any amount of time (holidays and such)

byhookorbycrook

Biz, I missed one or two last year due to (unrelated) illness, so you could miss if you really had to. Haven't relapsed since I started in 2009 and no changes in my scans either.

bizmark

you would recommend it then? how do you generally feel after the infusion ?

byhookorbycrook

I am normally tired, but that's because I have a long drive there and back. It's always a Sunday, so at least I don't tend to miss work.We know the dates a year ahead too.
I had two relapses in quick succession and they both damaged my "good" leg, so have been pleased with my Tysabri treatment thus far.

bizmark

might go down that route was told last week though that i could be waiting till april to see the nero even though i havent been on meds now since november :rolleyes:

nedsgarden

U.K. seems to be going ahead.


http://www.bbc.co.uk/news/health-17399056

hdunne

wow thats brilliant that NICE have approved. I started on this drug last week even though not approved in ireland yet. i was nervous but its great, zero side effects as yet, tablet once a day, nurse was great, fingers crossed i'm relapse free foe some time. hopefully won't be long until approved and available here in ireland.

kiwilemon

sorry to be so personal but did your wife start on the gilenya and how is it going

fergal.b

kiwilemon wrote: »

sorry to be so personal but did your wife start on the gilenya and how is it going

They said it might be going ahead in April so fingers crossed.

fergal.b

We got the call to start the new treatment next tuesday then she got the call to go to the mather on tuesday to get her gallbladder removed after 2 years on the waiting list "what are the chances" :mad:
I hope the place for the treatment will be passed on to one of you.

byhookorbycrook

ah blast, can she not do both?

fergal.b

byhookorbycrook wrote: »

ah blast, can she not do both?

No, they said the drug would be too hard on the system, this is her 13 th abdominal op "nothing to do with MS" so with all the scar tissue they can't do key hole. There is a 10 week recovery time for healthy people let alone someone with MS We will just have to wait and see. Some people just can't seem to catch a break but she's a fighter.:)

byhookorbycrook

Makes sense, but totally infuriating. Hopefully she'll get sorted soon.

bnt

Anyway, the EU regulators are still supporting Gilenya with some changes to the labelling w.r.t. heart conditions and monitoring after the first dose. Only people with existing heart conditions have any real cause for concern, in their opinion.

femur61

Great news, I've RR MS and been on injections for 11 years. No horendous side effects from the injections but injection sites still very sore. I haven't deteriorated at all and minor problems but unfortunately no one knows if I am one of the lucky ones where the drug is working or do I have a fairly subtle form of the disease.

byhookorbycrook

That's the problem with MS,isn't it, we take all these pretty awful meds,hoping they are actually doing something!

femur61

Are there many people getting this? I know it is not funded my the governemnt yet. I got an email from MS Ireland yesterday and it was going to feature on Primetime. Did it? Would be great to get as I am finding the injections difficult now. My skin will get very bumpy when injecting and sore:(.

fergal.b

Hi femur61 it is going ahead my wife was meant a few weeks ago but because of her op it was but off for a bit, when I was down at our local pharmacy they told me that they had received her new drug and now have it in stock ready to go, hopefully in the next few weeks she will get started

hdunne

femur61 wrote: »

Are there many people getting this? I know it is not funded my the governemnt yet. I got an email from MS Ireland yesterday and it was going to feature on Primetime. Did it? Would be great to get as I am finding the injections difficult now. My skin will get very bumpy when injecting and sore:(.

Hi there, for me i got this drug from drug company as i was put forward as 'first line' drugs not doing the job for me! i'm sure its quite expensive so i don't see people going on this because of injection site reactions, etc. if the injections are doing there job they may leave u on them.

fergal.b

Back on track to start the gilenya in the morning she will be under observation for the day to make sure there are no side effects as she is still very week and in a lot of pain from the op plus her liver function test was a bit high from the pain killers and antibiotics, so fingers crossed all goes well.

fergal.b

All went well today with no problems the only side effects so far are a metal taste in her mouth but that should go, the nurse said there are 65 people in Ireland on the drug now and although it has been approved the funding is still not through.

femur61

Great news hope all goes well. i am going to see my neuro next month. I have been injecting betaferon for 11.5 years now. I am really begining to hate it, the injection takes a little bit longer and if I inject sometimes when the fluid is going in little blisters will appear while injecting. If I rub them vigorously they will go.

I know funding is an issue but I was thinking I will suggest to substitute the cost for current medication to Gilenya. I am running out of sites and really, really hate injecting so much I will put it off for days!

byhookorbycrook

Femur, have you talked to your neuro as to which would be better for you (hatred on self injection aside?)

femur61

byhookorbycrook wrote: »

Femur, have you talked to your neuro as to which would be better for you (hatred on self injection aside?)

Next month.