Tecfidera - a mistake to make it oral?

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.

Tecfidera - a mistake to make it oral?

Postby euphoniaa » Tue Apr 02, 2013 9:25 am

Wow, maybe the newly released oral MS med Tecfidera (previously BG-12) should have been an injection med instead!! :-D Am anxious to hear how debilitating the nausea, vomiting & diarrhea side effects are. Apparently they're enough for patients to stop the med.

Although an irritable digestive system might be characterized as "minor" and not very life-threatening, dealing with constant and/or severe stomach flu-type symptoms could easily ruin one's life... and one's job. Should it have been an injection?

The most common side effects of TECFIDERA include:
**flushing, redness, itching, or rash
**nausea, vomiting, diarrhea, stomach pain, or indigestion
Flushing and stomach problems are the most common reactions, especially at the start of therapy, and
may decrease over time. Call your doctor if you have any of these symptoms and they bother you or do
not go away.


FYI - Here are links from the main Tecfidera.com website.

Tecfidera "Full Prescribing Information": http://tecfidera.com/pdfs/full-prescrib ... mation.pdf

And the super short summary, the "Patient Information" leaflet: http://tecfidera.com/pdfs/patient-information.pdf
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: Tecfidera - a mistake to make it oral?

Postby patticake66 » Tue Apr 02, 2013 3:18 pm

These symptoms you mention subside within one month's time in almost all patients. Don't you think one month of discomfort is worth not having to inject poison everyday? Think about what you are saying. This medication is way more safe than any other MS med. and way more effective. I could see not taking the drug anymore if these symptoms persist throughout your life but by God give it a chance before you start knocking it.....nothing, especially medication, is perfect.
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Re: Tecfidera - a mistake to make it oral?

Postby euphoniaa » Tue Apr 02, 2013 4:14 pm

patticake66 wrote:These symptoms you mention subside within one month's time in almost all patients. Don't you think one month of discomfort is worth not having to inject poison everyday? Think about what you are saying. This medication is way more safe than any other MS med. and way more effective. I could see not taking the drug anymore if these symptoms persist throughout your life but by God give it a chance before you start knocking it.....nothing, especially medication, is perfect.


Wow, patticake, I guess you told me!! :smile: What the hell?

My main point was that with the drug companies' determination to produce oral MS meds, maybe they missed an opportunity to make a much better, more tolerable injectable instead. It was just a thought after all... This med actually sounds like it has the potential to be a more effective, more tolerable MS med than the other options and I've actually spent the day researching it from many angles.

And, like I said, I'm anxious to find out precisely how debilitating these side effects turn out to be. Does one vomit profusely all day every day for a month? Have a mild attack of nausea once a week? Would I have time to hobble down the long hallway to the bathroom at work with my cane, or would I suddenly shit my pants without warning, at the office in front of my boss, the Vice President?

Other considerations...I can't identify any recent (or even long ago) exacerbations and my brainful of lesions never light up on my MRIs. And I have a history of serious reactions to many oral meds, oral supplements, and much of what I try to eat. I could even be allergic to the filler in an oral MS med.

Wishing good health, good reasoning, good choices, and a good sense of humor to all. :smile:
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Re: Tecfidera - a mistake to make it oral?

Postby Anonymoose » Tue Apr 02, 2013 5:19 pm

Tummy issues might be the least of bg12 problems. Bg12 incites an anti-inflammatory reaction by depleting glutathione, an endogenous antioxidant. Ever google glutathione deficiency and cancer? http://scholar.google.com/scholar?q=glu ... CDIQgQMwAA. Yikes!
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Re: Tecfidera - a mistake to make it oral?

Postby centenarian100 » Tue Apr 16, 2013 12:09 pm

Interesting idea euphoniaa

maybe they should make an injectible formulation

The problem with this is that BG-12 may not be much more effective than other first line therapies.

For example, in the "CONFIRM" study, BG-12 wasn't much more effective than copaxone (anualized relapse rate 0.20 vs 0.29; p = 0.01) and is arguably less well tolerated

Difference in disability progression between copaxone and BG-12 were non-significant

source:

http://www.ncbi.nlm.nih.gov/pubmed/22992072
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Re: Tecfidera - a mistake to make it oral?

Postby MBLG » Fri Apr 19, 2013 2:10 pm

I've been on BG12 for over 5 years and at the correct dosage. I still occassionally get a little flushing. I never vomited but did get lower digestive upset for about a month. It was quite bad but didn't last more than a couple of months.

Hope this helps!

MB
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Re: Tecfidera - a mistake to make it oral?

Postby Fectidera » Tue May 07, 2013 7:07 pm

Hey Anonymoose, I can play Internet medical researcher too!

Did you hear that elevated levels of glutathione protects cancerous cells in bone marrow, breast, colon, larynx, and lung cancers?? OMG Tecfidera helps cure cancer!1!!!

http://onlinelibrary.wiley.com/doi/10.1 ... aintenance

Or how about we try avoiding the hysterical scaremongering and focus on what we actually know about the drug through the actual (and extensive) human trials that have been run?
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Re: Tecfidera - a mistake to make it oral?

Postby NHE » Tue May 07, 2013 7:26 pm

Fectidera wrote:Hey Anonymoose, I can play Internet medical researcher too!

Did you hear that elevated levels of glutathione protects cancerous cells in bone marrow, breast, colon, larynx, and lung cancers?? OMG Tecfidera helps cure cancer!1!!!

http://onlinelibrary.wiley.com/doi/10.1 ... aintenance

Or how about we try avoiding the hysterical scaremongering and focus on what we actually know about the drug through the actual (and extensive) human trials that have been run?


There's no hysteria involved...

Dimethylfumarate is a strong oxidizing agent and has been reported by Biogen to cause chronic depletion of glutathione. This is a characteristic of several disease states such as ALS and Parkinsons and others.

Fumarates improve psoriasis and multiple sclerosis by inducing type II dendritic cells.
J Exp Med. 2011 Oct 24;208(11):2291-303. Epub 2011 Oct 10.

    Fumarates improve multiple sclerosis (MS) and psoriasis, two diseases in which both IL-12 and IL-23 promote pathogenic T helper (Th) cell differentiation. However, both diseases show opposing responses to most established therapies. First, we show in humans that fumarate treatment induces IL-4-producing Th2 cells in vivo and generates type II dendritic cells (DCs) that produce IL-10 instead of IL-12 and IL-23. In mice, fumarates also generate type II DCs that induce IL-4-producing Th2 cells in vitro and in vivo and protect mice from experimental autoimmune encephalomyelitis. Type II DCs result from fumarate-induced glutathione (GSH) depletion, followed by increased hemoxygenase-1 (HO-1) expression and impaired STAT1 phosphorylation. Induced HO-1 is cleaved, whereupon the N-terminal fragment of HO-1 translocates into the nucleus and interacts with AP-1 and NF-κB sites of the IL-23p19 promoter. This interaction prevents IL-23p19 transcription without affecting IL-12p35, whereas STAT1 inactivation prevents IL-12p35 transcription without affecting IL-23p19. As a consequence, GSH depletion by small molecules such as fumarates induces type II DCs in mice and in humans that ameliorate inflammatory autoimmune diseases. This therapeutic approach improves Th1- and Th17-mediated autoimmune diseases such as psoriasis and MS by interfering with IL-12 and IL-23 production.

BG-12, chemically known as dimethylfumarate, is an Nrf2 transcription factor activator. If you want to turn on Nrf2, then there are many natural products to do it. For example, an enhanced absorption form of curcumin such as BCM-95 curcumin or phytosome curcumin would be a good choice.

See this paper for a discussion of more natural Nrf2 activators...

Nrf2 as a Master Redox Switch in Turning on the Cellular Signaling Involved in the Induction of Cytoprotective Genes by Some Chemopreventive Phytochemicals
https://www.thieme-connect.com/ejournal ... 088302.pdf

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Re: Tecfidera - a mistake to make it oral?

Postby Anonymoose » Wed May 08, 2013 5:05 am

Fectidera wrote:Hey Anonymoose, I can play Internet medical researcher too!

Did you hear that elevated levels of glutathione protects cancerous cells in bone marrow, breast, colon, larynx, and lung cancers?? OMG Tecfidera helps cure cancer!1!!!

http://onlinelibrary.wiley.com/doi/10.1 ... aintenance

Or how about we try avoiding the hysterical scaremongering and focus on what we actually know about the drug through the actual (and extensive) human trials that have been run?

Fect's linked abstract:
http://onlinelibrary.wiley.com/doi/10.1 ... aintenance
Abstract
Glutathione is an abundant natural tripeptide found within almost all cells. Glutathione is highly reactive and is often found conjugated to other molecules via its sulfhydryl moiety. It instils several vital roles within a cell including antioxidation, maintenance of the redox state, modulation of the immune response and detoxification of xenobiotics. With respect to cancer, glutathione metabolism is able to play both protective and pathogenic roles. It is crucial in the removal and detoxification of carcinogens, and alterations in this pathway, can have a profound effect on cell survival. However, by conferring resistance to a number of chemotherapeutic drugs, elevated levels of glutathione in tumour cells are able to protect such cells in bone marrow, breast, colon, larynx and lung cancers. Here we present a number of studies investigating the role of glutathione in promoting cancer, impeding chemotherapy, and the use of glutathione modulation to enhance anti-neoplastic therapy. Copyright © 2004 John Wiley & Sons, Ltd.

Since most of us don't have cancer, I'm not sure how relevant the rest of the document is for PwMS. Maybe BG-12 would be perfect for those of us with cancer and MS.

I hope they don't find an increased risk of cancer in those of us trying BG-12. However, the bottom line is that BG-12 is just another way of handling our immune response. It does so via a unique and probably harmful mechanism, depleting our glutathione to induce an anti-inflammatory response. There are other means of modulating our immune response, including off-label drugs, herbals, and nutritional supplements.

If being an informed patient means I have to be an internet medical researcher, I guess that's just what I'll have to be.

Fect, if you are taking BG-12, I am sure everyone would be interested in hearing how it goes so please do share your experience.
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Re: Tecfidera - a mistake to make it oral?

Postby KDGO » Fri May 10, 2013 10:05 am

I've been on BG12 for over 5 years and at the correct dosage. I still occassionally get a little flushing. I never vomited but did get lower digestive upset for about a month. It was quite bad but didn't last more than a couple of months.

Hope this helps!

MB

If you have been on this for 5 years does that mean you don't live in North America? What results have you experience? Thank you for sharing.
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Re: Tecfidera - a mistake to make it oral?

Postby Kittykat74 » Sun May 26, 2013 12:16 am

3 days in... No stomach issues AT ALL. Taking 2mg Immodium as preventative measure. Mild flushing tonight after 2nd dose. Thankful to be done with Copaxone.
optic neuritis/ CIS dx April 2011
Started Tecfidera 5/23/13 / Immodium 2mg per day preventative.
Copaxone Sept 2011-Nov '12
Vit. D3 4000 IU, 270 mg Allegra. No dietary restrictions. Exercise: 10-15 miles walking/week.
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Re: Tecfidera - a mistake to make it oral?

Postby Holls » Thu Jun 13, 2013 9:09 am

Hi. I started taking Tecfidera shortly after it was released. I was nearly in tears before I started because I didn't want to deal with the horrible alleged side effects, but mine have been very minimal--almost nothing. I feel slightly warmer all the time and my stomach has felt a little off. Nothing debilitating though. I do find that my stool is softer, but it's not runny. As long as I'm not only eating cherries and spinach, I'm fine. I actually found this site because I was googling to see if anyone else taking the med had achiness in their spine or if that pain is completely unrelated. Anyone else have that? Good luck if you decide to make the switch!
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Re: Tecfidera - a mistake to make it oral?

Postby KDGO » Thu Jun 13, 2013 10:10 am

Thank you for letting us know how you are doing. By any chance were you ever tested for the JC virus? The ingredients are different than those that cause infection but just curious if it a norm for MSers to be tested for that virus.
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Re: Tecfidera - a mistake to make it oral?

Postby arlou8 » Mon Jun 17, 2013 12:31 pm

Hello to you all! I have been on these new meds going on my fourth week now. The first two weeks I had nothing except slight flushing. The second day of my third week was a whole different story. It seems that anything that I eat, for the next 2 1/2 hours, I am stuck staying very close to a bathroom. Twice now, I have woken in the early hours of the morning with nausea and immediate vomiting. The pain seems to go away right after. My stomach though seems to stay sore and agitated all the time. As I was reading up on side effects, I came across someone else's blog on the proper foods to eat while taking this medication. It seems that starch, protein, and eggs were a very important part of eating with medication for breakfast. This person stated that one coated aspirin taken with all other meds one hour before taking Tecfidera with breakfast helped a great deal. Eat normally for lunch, but nothing acidic for dinner. The meds taken with dinner was the same as with breakfast in that you take one coated aspirin one hour before your supper and to then take the Tecfidera with your supper. So, being a breakfast hater, I took myself off to the local restaurant and got a chicken egg and cheese bagel one hour after taking the coated aspirin and my vitamin D 5000. I took my meds with my breakfast and the results have been astounding. I did not have to stay near a bathroom and the few times that I did have to go it was no longer like pure water. I am extremely hopeful that within a few days, and sticking to this type of diet, things will straighten out. If I did not mention before, I no longer had flushing after the first couple of weeks. I would like to know if anyone else has found any diet that helps in this area.?
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Re: Tecfidera - a mistake to make it oral?

Postby Cece » Tue Jun 18, 2013 1:29 pm

Anonymoose wrote:Tummy issues might be the least of bg12 problems. Bg12 incites an anti-inflammatory reaction by depleting glutathione, an endogenous antioxidant. Ever google glutathione deficiency and cancer? http://scholar.google.com/scholar?q=glu ... CDIQgQMwAA. Yikes!

Thanks, Anonymoose. Helpful information.
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