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Tecfidera Revisited: An 18-month Review

If you have followed my articles for any length of time, you know that I take Tecfidera, one of the three oral MS disease-modifying therapies. In this piece, I’ll be discussing 1) an update of my personal experience with the drug and the drug support program, and 2) some new information that has been published about its efficacy, side effects and risks since the FDA released it into the specialty drug market in 2013.

I started Tecfidera in September 2013, nearly two years ago. The side effects I experienced from the beginning and up until recently had only to do with a little facial tingling about an hour after taking a capsule, and which lasted for a short interval. But about two months ago, I took a capsule and sat at the computer to web surf. I glanced down at my hands on the keyboard and saw that my skin was bright red. I hadn’t experienced flushing since the first day on the drug nearly two years earlier, so I logged it on my calendar as a reminder to mention it to my specialty pharmacist when she next made her bi-monthly phone call.

Sara, my specialty pharmacist, who is absolutely fabulous and doesn’t miss a thing, asked if I take the capsules with food. I did not. She said that eating something will help lessen the side effects. You can also take a 325 mg aspirin before or after the dose to help with the flushing. That I already knew, but I hadn’t had flushing until that one day, only the face tingling. So I take each dose with food now and not only do I have no flushing, I also have no more facial tingling as of this writing. I guess the moral of the story is to thoroughly read the literature you receive about how to take your medication, whether on an empty stomach or with food. And never underestimate the know-how of your specialty pharmacist, s/he is the go-to person for questions about drugs, studies, and stuff you wouldn’t think they’d be up on. More than once I’ve asked my neuro about something and gotten a blank look, but my pharmacist had an answer and a solution that worked for me.

Sara and I discuss all my meds, not just Tecfidera. Drug interactions and their side effects are an important part of the whole of my disease management. She even discusses exercise and diet, mood and stress and personal things going on with me. This thoroughness presents a clear picture of what life events and drugs I’m taking might be impacting my mood and causing physical discomfort or non-compliance or abnormal test results, not to mention quality of life. For example, a common side effect of Tecfidera is a lowered white blood cell count, which I now have. (Note: My WBC is still in the normal range, it’s at the bottom of normal.) I’ve had to treat a bladder infection recently as well as yeast. I’ve had persistent facial dermatitis for several months, albeit a mild case. These infections could be attributed to a weakened immune system caused by Tecfidera. Sara collects the oral data I share and offers this kind of analysis that I’m sure to bring to my next neuro appointment. And she follows up on our talk the next time she phones, checking out my progress on points I had long forgotten. She’s like my second brain, only smarter and without MS lesions.

I just can’t say enough good things about this aspect of Biogen’s protocol for Tecfidera users. It’s like having a direct line to a medical group that considers you a VIP and will always take your call even if it means putting the President on hold. Being a Tecfidera user, you are assigned your own personal pharmacist, like my Sara, with whom you will work the entire time you’re on the drug.  How special is that? I feel like a celebrity who could walk into Carbone without a dinner reservation and get immediately escorted to a table by an obsequious maitre d. It’s like getting handed a key to the VIP washroom where a handicap-accessible towel attendant dries my hands after I wash them. Stuff the ADA couldn’t wangle for us, not even for a bribe.

As much as I’ve enjoyed the perks of Tecfidera usership, however, I cannot ignore the ongoing investigations of long-term use and its findings. Here’s one that recently came to light:

A 54-year-old woman who was in the DEFINE trial and taking the dimethyl fumarate compound called BG-12, a.k.a. Tecfidera, for a year in the open-label trial phase, developed severe lymphocytopenia, or low white blood cell count, that persisted for 3.5 years. Her RRMS was stable with no activity until August, 2014, when she developed symptoms consistent with MS. Intravenous steroids and plasmapheresis did not make her improve, and she was taken off Tecfidera. In October 2014 she was diagnosed with PML and tests showed she was also JCV-positive. She died later that month.1

As scary as this scenario may sound, it isn’t statistically significant. “Considering this single case of PML, and based on the experience in over 135,000 patients with MS treated with Tecfidera corresponding to 112,000 patient-years of exposure, the overall benefit/risk profile of Tecfidera has not changed,” Todd Cooper, spokesman for Tecfidera Drugmaker Biogen idec said in an email to MedPage Today.1

The most important thing to take away from this report is that we know it’s possible to develop lymphocytopenia after starting Tecfidera, and to become JCV-positive within a short period. These two conditions can make us vulnerable to developing PML. Therefore, twice per year blood testing is vitally important. My neuro has me going in for the blood work every six months. She has told me that I can stay on Tecfidera as long as my white count doesn’t dip below the normal range and stay there for a certain interval.

So if you’re feeling kind of off, as always, call your neuro’s office. If you suspect it might be an issue with your meds and your doc can’t answer your questions, call your specialty pharmacist to discuss drug side effects/symptoms/interactions issues. If your pharma doesn’t offer this service, talk to the nurse or rep of your patient support program. And if that doesn’t give you the answers you need, contact the peer support program of an MS organization like the NMSS, or an online support site such as MS.net for ideas.

It’s all about being your own advocate. Let’s not get hysterical and keep in mind that the overwhelming majority of us stand an excellent chance of taking our disease-modifying therapies with no serious issues. Best of luck to all of us who take these high-priced/high risk drugs.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The MultipleSclerosis.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. Fiore, K. Dimethyl Fumarate PML Cases Detailed. Med Page Today. 2015.

Comments

  • rbtstewart@att.net
    4 years ago

    Your article about tecfidera was interesting and made me wonder about food interaction with the drug. I called and found that there was no anecdotal information on the subject. However, after months of being on the drug I began to experience, about an hour and forty-five minutes after eating, dizziness, the inability to stand without falling and vomiting. I stopped taking the drug for six days and conditions seemed to improve until I got sick again. After calling the doctor, I started back on tecfidera. This time, I started thinking about foods so I began to eliminate certain foods. I started with milk and cheese and now, for a period of several weeks I have not had another instance of the nausea and vomiting. So far so good, but I do continue to have the flushing. It would be interesting to see if certain foods have a relationship to side effects of tecfidera.

  • Nobu
    4 years ago

    Hi Kim and everyone.
    Janice – keep good notes on how you are feeling and how the side effects may impact you. Get to know your neuro and MS nurse so you know who to contact and when. It will make taking the medications easier for you.

    I have been on Tecfidera for about 2 years. Prior to that, I was on Gilenya but my neuro wanted me to switch because along with having been on Novantrone, this would be two meds with cardio issues. They are not the same issues but still impact the heart. I have testing every six months right now for Tecfidera, and will change frequency per my neuro’s directions if the numbers should warrant it. My side effects have been digestive rather than the flushing. The upset GI was most prominent when I first started taking T but since then, I very rarely have any issues to concern me. My neuro is originally from Germany and has read up on all of the issues related to the family of meds that were also used for other autoimmune conditions in Germany so I feel very comfortable that she has great knowledge from the sources.

    I was on a drug trial first before I started taking a standard MS med which was Copaxone. I tolerated Copaxone very well, and only changed when my MRI indicated my MS was not being well controlled.

  • Janice
    4 years ago

    It was good to get your opinion of Tecfidera. Right now I am scared to death about starting it. I have been diagnosed with MS since 2002 but I had optic neuritis ten years before that. My neuro at that time I was diagnosed said it was benign and the drug therapy would be worse than the MS. I just went into “I will be OK” mode and didn’t think much more about MS. I moved to another state and didn’t even think about the MS for a few years until I had problems with one of my eyes and I was told I needed to get an MRI. I was told that MRI showed that I should be seeing a neurologist and get on drug therapy. I was in a small country town so getting to a neurologist was not easy. First they were an hour away and getting an appointment with one was not easy. When I finally found one to take me as a patient I was immediately told I should start a drug therapy. I really had a hard time even thinking about it because I had never had anything to make me think I needed to start. The side effects scared me so I didn’t want to take it. After 10 years I was told I should try rebif and it wouldn’t cost me anything. I decided to try it. After three months my depression which I have always suffered with became worse. I stopped the rebif myself because I knew my depression was getting too bad.
    I have not been on any other drug therapy because that scared me too much. I am now back where I was originally diagnosed with MS and have gone to a new neurologist. I was told for the first time that I had too many lesions not to be on any therapy. She is starting me on tecfidera. First the expense will have to be covered because I can’t afford it. I am still concerned about the side effects because I will feel worse than I do now. My biggest problems are my depression, cognition and my eyes. I had read about the one that died taking tecfidera. All that I read only scares me to start any drug therapy. It is hard to justify the benefits because of the negatives.

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