120 mg or 240mg Tecfidera dose

[BLD]

Hi All,
I'm a new MS patient. I'm older than the average newcomer at 53 and male. My initial outbreak was limited to slight facial paralysis, which passed after several days and double vision/vertigo which went away with steroids. I'm now on a regime of Tecfidera 240mg twice daily. My question is this. Do I really need to be on such a heavy dose as this? Is anybody doing a lesser dose with a good outcome. This is a question I'm going to ask my neurologist for sure but I was curious if anyone could answer this for me.

[Scott1]

Your question is a very good one. I was unable to find reason why the dosage changes and what evidence exists that the higher dose is optimal.
Ultimately I could not manage the higher dose but I don't know if the reason was cumulative use or dosage per time.
I am not on it now and was troubled by the involvement in solid tumor development and PML.

Regards

[ElliotB]

It appears the initial does is less (for the first week) and then the normal dose is 240mg:

http://www.drugs.com/tecfidera.html

[Froggie]

Hi BLD- The main reason why you start at a lower dose is to get the body acclimated to said drug. This is common with many drugs and not just Tecfidera. Depending on which one you're taking, you'll start at a lower dose and titrate up to the full amount after about a week or so. If you are tolerating it, great. If not, you may have to be patient with it until you adjust.

[BLD]

Hi All,
Thank you for your comments! I'm at the 2-240mg dosage at this point. I guess I didn't phrase my question correctly. So, I'll try again. Are there individuals that are on a regime of a lesser dose? Is it just assumed everybody will be on the 2-240mgs a day dosage regardless of the severity of their MS?
So far, I've had just a couple flushing episodes, some aches/soreness, but nothing overtly alarming. No GI issues either... But, I'm just curious about dosage and was wondering if I "need" such a high dose.
As I stated in my first post, I'm definitely going to have this conversation with my neurologist.

[euphoniaa]

Hi All,
Thank you for your comments! I'm at the 2-240mg dosage at this point. I guess I didn't phrase my question correctly. So, I'll try again. Are there individuals that are on a regime of a lesser dose? Is it just assumed everybody will be on the 2-240mgs a day dosage regardless of the severity of their MS?
So far, I've had just a couple flushing episodes, some aches/soreness, but nothing overtly alarming. No GI issues either... But, I'm just curious about dosage and was wondering if I "need" such a high dose.
As I stated in my first post, I'm definitely going to have this conversation with my neurologist.

Hi BLD, and welcome!

I have no idea how to answer your specific question -- which is definitely one for your neurologist -- but, in case you haven't found it yet, our site has a whole sub-forum for Tecfidera posts and you may find more helpful info & patient experiences there: http://www.thisisms.com/forum/tecfidera ... arate-f52/

Also, you can always get the official, "Full Prescribing Information" for a med at their own website, which may help explain the dosage as well, along with results from the original studies: http://www.tecfidera.com/pdfs/full-pres ... mation.pdf

Good luck, and keep us posted how you're doing.

[carolsue]

Excellent question. I had the same question for my neuro when I was on Rebif because I seem to have a mild disease course. The answer was: "MS is a nasty disease; if you're tolerating the higher dose, why would you want to mess around?"
I'm on Tec these days and I do wonder the same thing. Please let us know how your neuro responds to your question.

[mmpetunia]

The dosage was measured for effectiveness through drug trial studies. It's possible that another dose would also be beneficial, however, there are likely no studies available showing one way or the other. Therefore most likely your neurologist will probably tell you that you need to be on 240 mgs twice a day-- because that's the only dose with data to back it up. This is probably especially true because it is a pretty new drug.

[BLD]

I'm hopeful that in time, we may not have to have such a strong dose... But, at this point, only time will tell.

[NHE]

I'm a new MS patient. I'm older than the average newcomer at 53 and male. My initial outbreak was limited to slight facial paralysis, which passed after several days and double vision/vertigo which went away with steroids. I'm now on a regime of Tecfidera 240mg twice daily. My question is this. Do I really need to be on such a heavy dose as this? Is anybody doing a lesser dose with a good outcome. This is a question I'm going to ask my neurologist for sure but I was curious if anyone could answer this for me.

One would have to look at the results of the phase 2 studies to see what the differences were in the dose response to Tecfidera. I recall that Biogen had published some papers on these. They should be available from Pubmed. Try searching for dimethyl fumarate.

[BLD]

Thank you! I'll look those up!

[NHE]

The following paper discusses one of the phase 2 studies that examined the effects of a dose response to BG-12. The abstract mentions that patients were treated with 120, 360, 720 mg/day or placebo. However, only the 720 mg/day results are discussed in the abstract. The full paper is not free, but you can likely get a copy at your local university's library.


Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study.
Lancet. 2009 Apr 18;373(9672):1340.

• BACKGROUND: Oral fumarate (BG00012) might have dual anti-inflammatory and neuroprotective effects. Our aim was to assess the efficacy and safety of BG00012 in patients with relapsing-remitting multiple sclerosis.
  
  METHODS: 257 patients, aged 18-55 years, with relapsing-remitting multiple sclerosis were randomly assigned to receive 120 mg once daily (n=64), 120 mg three times daily (n=64), or 240 mg three times daily (n=64) BG00012, or placebo (n=65) for 24 weeks. During an extension period of 24 weeks for safety assessment, patients treated with placebo received BG00012 240 mg three times daily. The primary endpoint was total number of new gadolinium enhancing (GdE) lesions on brain MRI scans at weeks 12, 16, 20, and 24. Additional endpoints included cumulative number of new GdE lesions (weeks 4-24), new or enlarging T2-hyperintense lesions, new T1-hypointense lesions at week 24, and annualised relapse rate. Analysis was done on the efficacy-evaluable population. Safety and tolerability were also assessed. This study is registered with ClinicalTrials.gov, number NCT00168701.
  
  FINDINGS: Treatment with BG00012 240 mg three times daily reduced by 69% the mean total number of new GdE lesions from week 12 to 24 compared with placebo (1.4 vs 4.5, p<0.0001). It also reduced number of new or enlarging T2-hyperintense (p=0.0006) and new T1-hypointense (p=0.014) lesions compared with placebo. BG00012 reduced annualised relapse rate by 32% (0.44 vs 0.65 for placebo; p=0.272). Adverse events more common in patients given BG00012 than in those given placebo included abdominal pain, flushing, and hot flush. Dose-related adverse events in patients on BG00012 were headache, fatigue, and feeling hot.
  
  INTERPRETATION: The anti-inflammatory effects and favourable safety profile of BG00012 warrant further long-term phase III studies in large patient groups.