The PROS and CONS of GILENYA

[ms man]

I haven't started Gilenya yet but would love your input.

[CrazyCatLady]

I have a thread called "Started my Glenya today." I started Dec 14th. So far no cons, I felt a little tired the first few days but that passed and I can't say for sure it was the Gilenya. As for pros, I love not injecting myself!!! The pill is easy to take, you don't have to worry about taking it with or without food just take it when it is good for you.

The only real con I guess it that they don't know how it will effect birth control pills which is a big deal for me but because your name is Ms Man I am assuming you don't take birth control pills. LOL! They do say for women to not get pregnant and use 2 forms of birh control if your first form is the pill. But really other then that I am happy so far. I hope this med works well for me!!!

[ms man]

I have a thread called "Started my Glenya today." I started Dec 14th. So far no cons, I felt a little tired the first few days but that passed and I can't say for sure it was the Gilenya. As for pros, I love not injecting myself!!! The pill is easy to take, you don't have to worry about taking it with or without food just take it when it is good for you.

The only real con I guess it that they don't know how it will effect birth control pills which is a big deal for me but because your name is Ms Man I am assuming you don't take birth control pills. LOL! They do say for women to not get pregnant and use 2 forms of birh control if your first form is the pill. But really other then that I am happy so far. I hope this med works well for me!!!

Glad that it's working for you.I'm considering it because I would love to take a pill instead of an IV infusion.

Ty has really worked for me and now that I'm doing Ty every other month it's not too bad.A pill instead of an IV would be awesome.What concerns me is the liver and heart probs.I don't like taking things that are so new.I like to give them some time before taking the plunge.I'll discuss all this with, my Neuiro i January.

Please be careful with the pill.It can be more dangerous than Ty or Gilenia.Stick to condoms.They're safer.

[Redwings]

Hi ms man:
If you want to know the cons of Gilenya, go to www.gilenya.com and read the Patient Medication Guide AND the Full Prescribing Information -- particularly the Warnings and Precautions section -- and the Safety Information Guide. The latter two can be found in the Healthcare Professionals section.

[Just a small town girl]

ms man-

I understand how you feel about new drugs. I work at a law firm whose primary practice is suing drug companies and medical devices for drugs and products that weren't properly tested and really hurt people. As far as medical studies go, the Gilenya studies were fairly extensive.

I've been on Gilenya for 6 weeks now. I had absolutely no change in heart rate. I did however have elevation in liver enzymes. Going in neither my neuro or I were that worried about the liver enzyme issue. I'm 26 and I don't drink. However that didn't stop the liver enzymes from hiking up. After week 5 they went almost all the way back down to normal.

From what I've learned, about half the time that the liver enzyme level does go up, it'll come back down on its own within 6 weeks or so. Otherwise, if your level is high enough, you get yanked off gilenya and your enzyme level should come back down on its own. From what I've read of the Gilenya studies, having elevated liver enzyme levels is a fairly rare side effect of the drug and the majority of the time doesn't actually cause any damage or permanent harm (because they blood test you like a mofo - for me schedule is right after, 1 week after, once a month for 3 months, once every 3 months for first two years; Once liver enzyme levels showed as elevated I was in every 2 weeks).

The thing that really helped me make my decision was my neuro reciting to me the actual incidence levels of some of these side effects (for me the biggies were heart, macular edema, and liver enzyme level). The incidence level is actually pretty dagone low.

Biggest thing I'd recommend is going to the New England Journal of Medicine's Website and downloading the results of the Gilenya studies. You can actually get the results from a lot of the big studies for free. Yes most of it sounds like Greek but the parts you care about like how many times someone had the heart problem or whatever else are in a nice little chart or in decipherable english.

I wish you all the best on your big decision!!! Tell us what you decide!

[ms man]

ms man-

I understand how you feel about new drugs. I work at a law firm whose primary practice is suing drug companies and medical devices for drugs and products that weren't properly tested and really hurt people. As far as medical studies go, the Gilenya studies were fairly extensive.

I've been on Gilenya for 6 weeks now. I had absolutely no change in heart rate. I did however have elevation in liver enzymes. Going in neither my neuro or I were that worried about the liver enzyme issue. I'm 26 and I don't drink. However that didn't stop the liver enzymes from hiking up. After week 5 they went almost all the way back down to normal.

From what I've learned, about half the time that the liver enzyme level does go up, it'll come back down on its own within 6 weeks or so. Otherwise, if your level is high enough, you get yanked off gilenya and your enzyme level should come back down on its own. From what I've read of the Gilenya studies, having elevated liver enzyme levels is a fairly rare side effect of the drug and the majority of the time doesn't actually cause any damage or permanent harm (because they blood test you like a mofo - for me schedule is right after, 1 week after, once a month for 3 months, once every 3 months for first two years; Once liver enzyme levels showed as elevated I was in every 2 weeks).

The thing that really helped me make my decision was my neuro reciting to me the actual incidence levels of some of these side effects (for me the biggies were heart, macular edema, and liver enzyme level). The incidence level is actually pretty dagone low.

Biggest thing I'd recommend is going to the New England Journal of Medicine's Website and downloading the results of the Gilenya studies. You can actually get the results from a lot of the big studies for free. Yes most of it sounds like Greek but the parts you care about like how many times someone had the heart problem or whatever else are in a nice little chart or in decipherable english.

I wish you all the best on your big decision!!! Tell us what you decide!

Thanks for the informative post.How long have you been on Gilenya?How has it helped you?Unlike you I do drink.I don't drink alot but I'll have a beer or two.Can a person drink on Gilenya?I'm sorry if I'm asking too many questions.

[Just a small town girl]

Thanks for the informative post.How long have you been on Gilenya?How has it helped you?Unlike you I do drink.I don't drink alot but I'll have a beer or two.Can a person drink on Gilenya?I'm sorry if I'm asking too many questions.

I've been on Gilenya for 6 weeks now. I'm newly diagnosed and have only had two episodes total that were spread out about 2 years with the last one (ON) this summer leading to my diagnosis. Accordingly, I'm not really sure how much it has or hasn't done, but I haven't had any relapses etc. but I kinda doubt I would have had a relapse so soon. I do know that it's very easy to just take my pill in the mornings and its really no different than taking my vitamin D or fish oil at this point.

You're definitely not asking too many questions. I believe that you can drink while you're on Gilenya. My neuro didn't tell me that I couldn't and didn't emphasize it. However, she did ask me if I did drink, etc. I think the reasoning behind that is just because of the risk of elevating your liver enzymes and the worry that if you drink a ton you might be starting with a liver that's not in the best shape and concern about not damaging your liver. If you're wanting to switch, your neuro will probably ask you about it. Unfortunately, I just don't know that much about where the line would really be.

Keep us posted on how things are going with you!!

[ms man]

I've been on Gilenya for 6 weeks now. I'm newly diagnosed and have only had two episodes total that were spread out about 2 years with the last one (ON) this summer leading to my diagnosis. Accordingly, I'm not really sure how much it has or hasn't done, but I haven't had any relapses etc. but I kinda doubt I would have had a relapse so soon. I do know that it's very easy to just take my pill in the mornings and its really no different than taking my vitamin D or fish oil at this point.

You're definitely not asking too many questions. I believe that you can drink while you're on Gilenya. My neuro didn't tell me that I couldn't and didn't emphasize it. However, she did ask me if I did drink, etc. I think the reasoning behind that is just because of the risk of elevating your liver enzymes and the worry that if you drink a ton you might be starting with a liver that's not in the best shape and concern about not damaging your liver. If you're wanting to switch, your neuro will probably ask you about it. Unfortunately, I just don't know that much about where the line would really be.

Keep us posted on how things are going with you!!

Thank you so much.I will definitely keep everybody posted as to what course I take.Again, thanks for your help.

[rocky282]

Tossing In

My neuro sent me to Dartmouth Hospital for a second opinion and the Neuro that I met there talked to me about Gilenya. He wanted me to understand that the pretests are necessary because there were 2 people that died during the trials. He basically scared the CRAP out of me. I don't think he was a big advocate for the med, he favored Tysabre over Gilenya. Not sure but he may have been involved with the trials. If something is working and it is only every other month, I might suggest to stay with it for a bit longer and let the Gilenya have a little more time in the field.

[Cindarelly]

I have had the chance to get 2 neuro's opinion.
One likes Ty the other likes G.
( I changed dr's in the middle of G coming onto the market.
So neither had a reason to to expect I would ever take it.

( the one that likes Ty has his own infusion center.)

[Portia]

I think it's odd and maybe a bit suspicious that a neurologist would scare patients by emphasizing two deaths in the Gilenya trials and then go on to recommend Ty which, according to all my reading, has led to deaths as well. I'd do what Redwings suggests and read the prescribing info on any medication I might consider taking.

[Just a small town girl]

I think it's odd and maybe a bit suspicious that a neurologist would scare patients by emphasizing two deaths in the Gilenya trials and then go on to recommend Ty which, according to all my reading, has led to deaths as well. I'd do what Redwings suggests and read the prescribing info on any medication I might consider taking.

It's important to remember that the deaths in the Gilenya trials were all at a higher dose than what people take AND while people were on steroids. Essentially doctors were taking people with lowered immune symptoms (that's what Gilenya does) and then completely tanking them with the steroids, when that happens just about any kind of infection is fatal. Absolutely no one has died from Gilenya at the approved dose or at the higher dose if they weren't on steroids.

I'm with Portia. I'm glad my neuro mentioned the deaths and then explained why they happened so I would be aware of the fact that steroids probably aren't a good option for me while I'm on Gilenya. However, Tysabri carries a risk that you can't really be sure of. It scares me, but I'm still at the stage where I don't have a ton of symptoms. More than anything just make sure you do what YOU are comfortable with.

[FlyerFan]

Cost?

I have been taken off Ty after my second go around after developing MAJOR hives and now a sore thoat that will not go away. I see my neuro in January and his assistant is telling me to push for Gilenya. I really seem to do well with Ty for the second time but I was a walking hive /rash person for a month??? My question-finally-how much is out of pocket for Gilenya. I have insurance(bluecross) through my former employer for 2011...?

[Just a small town girl]

Unfortunately no one can tell you that besides your insurance company. I've got Anthem BCBS Blue Access PPO and was told that Gilenya is a tier 4 drug, same as copaxone or avonex (those were the others I was checking). Regardless of which drug I choose my co-pay was going to be 25% with a cap at $2,500 / year. So my initial thought is that your co-pay percentage, etc. should probably be the same, however I'd take the time to call your insurance company and check.

If you do decide to go with Gilenya, Novartis is paying up to $800 of your co-pay through December 2011. This means that if your co-pay is $1,000, you'll only pay $200. They set it up as an automatic payment to the specialty pharmacy you use. The only way you don't get the full $800 is if your co-pay is less than $800.

Hope this helps.

[ms man]

I've been on Gilenya for 6 weeks now. I'm newly diagnosed and have only had two episodes total that were spread out about 2 years with the last one (ON) this summer leading to my diagnosis. Accordingly, I'm not really sure how much it has or hasn't done, but I haven't had any relapses etc. but I kinda doubt I would have had a relapse so soon. I do know that it's very easy to just take my pill in the mornings and its really no different than taking my vitamin D or fish oil at this point.

You're definitely not asking too many questions. I believe that you can drink while you're on Gilenya. My neuro didn't tell me that I couldn't and didn't emphasize it. However, she did ask me if I did drink, etc. I think the reasoning behind that is just because of the risk of elevating your liver enzymes and the worry that if you drink a ton you might be starting with a liver that's not in the best shape and concern about not damaging your liver. If you're wanting to switch, your neuro will probably ask you about it. Unfortunately, I just don't know that much about where the line would really be.

Keep us posted on how things are going with you!!

Thanks for the info.The fact that your Doc didn't ask if you drink tells me that you can drink while on G.
I'm scheduled for my next Ty on 1/6 and will meet with my Neuro also.I've been on every other month Ty since November and if he keeps me on that schedule I thing I'm staying with Ty.