Tecfidera

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Tecfidera

Postby daverestonvirginia » Mon Jun 03, 2013 4:50 am

Just returned from my 6 month visit to my neurologist. Really like him, I have been a patient of his for over 8 years, since I was dx. He is really excited about Tecfidera, he wants to get me on it as soon as I feel comfortable about switching from Copaxone. Says it is better than Copaxone with little or no side effects. Only thing I guess it has only been available for several weeks. He believes if things go the way he expects them to it is going to be the big oral drug for MS. I have been doing very well on Copaxone, but I could do without having to give myself the injections. Wanted to hear what other people are starting to hear.
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Re: Tecfidera

Postby Loriyas » Mon Jun 03, 2013 9:54 am

I have a follow up with my neurologist in July. I think he may suggest Tecfidera also. I, too, am currently on Copaxone. I also have been doing the antibiotic protocol for 4-5 years. I am doing very well. At this point I have decided to wait on Tecfidera if in fact he suggests it. I don't want to "rock the boat" and I want to wait until more data has come out after Tecfidera has been in use in the US for MS. I am seeing people on this site complain of pretty uncomfortable to painful stomach pains as well as flushing. I want to wait to see how that all shakes out. Of course, if I were not doing well currently my decision most likely would be very different. I am lucky to have the luxury of waiting and I appreciate those who share their experiences with Tecfidera on TIMS.
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Re: Tecfidera

Postby cheerleader » Mon Jun 03, 2013 1:50 pm

Hi Dave--
I'm sure you know this, but the MOA for copaxone is very, very different than Tecfidera, which uses the NRF2 pathway. Tecfidera depletes your liver of glutathione (an important antioxidant) and uses a pro-oxidant pathway to encourage your body to respond by cranking out more antioxidants. It also has been known to severly deplete lymphocytes, causing lymphopenia in some, and that is a concern...you'd need to be monitored for this. The flushing and all of those nasty gastrointestinal side effects (which affect 60% of people who take it) might be a drag, too. And yes, PML can be a cause for concern with long term use.
Marc (wheelchair Kamikazee) wrote up a good review:
http://www.wheelchairkamikaze.com/2013/ ... d-pml.html
my review is probably a bit more damning, but I'm not a fan. I have links to research and commentary.
https://www.facebook.com/notes/ccsvi-in ... 4812867211

Good luck to both of you, whatever you decide...believe me, Jeff would love to ditch the needles...but he's not wanting to rock the boat just yet, either.
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dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Tecfidera

Postby daverestonvirginia » Tue Jun 04, 2013 7:42 am

Cheerleader, thank you for your informative response. I do not intend to make any quick changes, but I have a feeling this drug is going to take off. Time will tell for me. Dave
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Re: Tecfidera

Postby HarryZ » Tue Jun 04, 2013 9:53 am

I have a feeling this drug is going to take off. Time will tell for me. Dave


Tecfidera will likely "take off" because nobody markets MS drugs better than Biogen. They will have their claws into the neuros and promote this new drug to the hilt. Positives will be stressed and negatives swept under the proverbial carpet. I really hope this drug helps MS patients but remember it is an immune system altering medication and long term safety info for its dosage is not known.

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Re: Tecfidera

Postby MarketingMaven » Thu Jun 06, 2013 3:20 am

Dave from Reston: my advice to you is stick with Avonex if it is working for you. I was doing great on Rebif but tried Tecfidera since it was an oral med. after 6 weeks on it, I had a bad flareup, first one in 8 years! Different drugs work differently for folks, and if you find one that is working, stick with it! With all due respect to your neuro, there ARE side effects. Most of us have either bad flushing or gastro issues or both. Mine did not lessen even after 6 weeks, but the worst was the flareup. I am now going through 5 days of IV solumedrol to treat it, and am feeling much better, and I am back on Rebif! Good luck to you!
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Re: Tecfidera

Postby Renee1503 » Fri Dec 27, 2013 4:17 am

I have been on Tecfidera 15 days, I have had one day of gastro issues on the second day of starting it and on the 7th day I had flushing but all my symptoms have subsided.
My neuro decided the best way to lessen side effects were to start on 120mg pill once a day for 14 days as well as an asprin half an hour before i take the Tecfidera pill.
I am so impressed on how I am feeling, I have increased the dose and this is my second day of the increased dose and hopefully I will continue to feel so good
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Re: Tecfidera

Postby j3apps44 » Wed Jan 08, 2014 12:42 pm

I've been on Tecfidera for just over a month now. It is first and only MS drug I've taken. I decided to take it since I wasn't keen on injecting myself daily and after reading various reports and studies decided to go for it. I have had no GI distress {NOTE: I've had for 20 years IBS-C, or something like that} and minimal flushing for two days. I'm on full dosage of 240mg/twice a day. As for other drugs I'm on--400mg/daily Carbamazepine, and that's it. Supplements--a multivitamin daily, 1000mg B12 several times a week, cod liver oil gel capsule a couple times a week, will start soon on 100 mg CoQ10 due to this: http://www.utsandiego.com/news/2014/jan ... ham-study/

Some very interesting info in this article such as it talking about another study from Oregon that states 'Dr. Reddy and colleagues found that an antioxidant called MitoQ reverses symptoms in mice with an MS-like demyelinating disease'.

So I looked up MitoQ and found that Wikipedia has this to say :The active antioxidant component of MitoQ is ubiquinone, which is identical to the active antioxidant in Coenzyme Q10. Here is link to info about CoQ10 from Linus Pauling Institute http://lpi.oregonstate.edu/infocenter/othernuts/coq10/
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Re: Tecfidera

Postby j3apps44 » Wed Jan 08, 2014 12:45 pm

Forgot to add this about Tecfidera--I spoke to a nurse at Tecfidera support line and she told me to take it with 'food that had fat', like yogurt or nuts or something like that. I take mine during [not before] my breakfast and dinner.
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Re: Tecfidera

Postby centenarian100 » Wed Jan 08, 2014 3:01 pm

I don't mean to disparage the drug, but I find some of the information from the pharmacology review to be very interesting.

For example, the pharmacology reviewer for the FDA did not recommend approval based on unresolved safety issues with regards to potential cancer risk and renal fibrosis:

It's quite a long read, but check out this quote from page 2:

"The pharm/tox reviewer did not recommend approval of this NDA based on the
nonclinical data. Renal toxicity in nonclinical species was the specific reason for
this conclusion. The pharm/tox supervisor agreed that the nonclinical studies
demonstrate the potential for renal toxicity."

http://www.accessdata.fda.gov/drugsatfd ... PharmR.pdf

There are several instances of cell dysplasia in multiple animal models

This actually did make it onto the package insert as well:

"Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration of DMF (25, 75, 200, and 400 mg/kg/day) for up to two years resulted in an increase in nonglandular stomach (forestomach) and kidney tumors: squamous cell carcinomas and papillomas of the forestomach in males and females at 200 and 400 mg/kg/day; leiomyosarcomas of the forestomach at 400 mg/kg/day in males and females; renal tubular adenomas and carcinomas at 200 and 400 mg/kg/day in males; and renal tubule adenomas at 400 mg/kg/day in females. Plasma MMF exposure (AUC) at the highest dose not associated with tumors in mice (75 mg/kg/day) was similar to that in humans at the recommended human dose (RHD) of 480 mg/day."

http://www.accessdata.fda.gov/drugsatfd ... 063lbl.pdf

However, to my knowledge, these issues have not been soon in humans during the clinical trials CONFIRM and DEFINE and have not been seen so far post-market...yet.

There are no specific guidelines for screening for potential renal complications

:)
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Re: Tecfidera

Postby Beachnut » Tue Feb 04, 2014 1:27 pm

I'm glad I found this discussion. I have been on Copaxone for years and Tecfidera has caught my eye. I am rather tired of the shots and wondered about the oral alternative. Now that I read some posts, I think I will question my neurologist when I see him this month. Since the drug is new, it is of course, all the rage but I have had side effects from some drugs I have been put on and needed to immediately come off. the Copaxone has been wonderful. No new lesions, no relapses. My thought, don't mess with a good thing until I learn more.

Best to all :smile:
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Re: Tecfidera

Postby ebodebo » Sat Apr 19, 2014 11:17 am

I have been using Tecfidera for close to 1 year. It's the only MS drug I've used at this point. I was newly diagnosed just before I started its use, but have had MS for 14 years now. As far as the side effects go, I suffer from stomach upset every morning when I get up, but honestly, it's not that bad. I also experience flushing in my head, face and sometimes my shoulders, and I often feel a loss of energy while the flush is occurring. The flushing sensation can last anywhere from 5 mins. to an hour; it's also not an incredibly bad experience. I haven't had an exacerbation yet since I started using Tecfidera, but I've only had 2 flare-ups in the 14 years I've had the condition. I'm currently suffering from shingles, which I've read occurs sometimes for people on certain immunosuppressant drugs. I am in no way blaming Tecfidera for this condition; I am wondering, however, if any one else has suffered with shingles while taking Tecfidera.
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Re: Tecfidera

Postby yvonne4248 » Sat Apr 19, 2014 10:43 pm

I read the forum and noticed after someone mentioned that dry skin is a side effect , I've realised this is a definite side effect for me. I flush like crazy with menopause but after stopping my BD aspirin with Tecfidera I've noticed its increased a bit. No gastro side effects at all
but over Easter I have run out of Tecfidera and now I'm off it for 2-3 days. I'm wondering what happens next, I will restart tomorrow.
Anyone know what happens with missed doses or duration of missed dose? Having been on Natalizimab for 5 years I've have no flare ups since prior to that.
No change in my immunity either.
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Re: Tecfidera

Postby centenarian100 » Sun Apr 27, 2014 11:34 pm

daverestonvirginia wrote:Says it is better than Copaxone with little or no side effects.


I don't necessarily accept this actually.

take a look at the CONFIRM trial: http://www.nejm.org/doi/full/10.1056/NEJMoa1206328

"In post hoc comparisons of BG-12 versus glatiramer acetate, differences were not significant except for the annualized relapse rate (thrice-daily BG-12), new or enlarging T2-weighted hyperintense lesions (both BG-12 doses), and new T1-weighted hypointense lesions (thrice-daily BG-12) (nominal P<0.05 for each comparison)."

Note that the twice daily dose (which is the available dose) did not beat copaxone in anualized relapse rate. There was only a non-significant trend toward superiority in this aspect. Also, the copaxone arm was not blinded in this trial. People obviously entered the trial for a chance to get the highly hyped dimethyl fumarate, so they were probably disappointed when they found out they were in the copaxone arm...perhaps making them more likely to feel negatively and more likely to report mild relapses compared to the tecfidera groups.

In reality, tecfidera probably is modestly superior to copaxone...but as cheer says...with potential safety and tolerability issues.

Also, copaxone isn't all that effective (failed to meet sustained disability endpoint in numerous trials including this one), so failing to convincingly beat copaxone is somewhat disturbing for tecfidera. Gilenya and tysabri destroyed avonex, and alemtuzumab destroyed rebif.

If you need a highly effective drug, tecfidera probably isn't the answer. If copaxone works well for you but you hate the shots and will risk the potential side effects, maybe tecfidera is reasonable.
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