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Thoughts on Tecfidera

11/26/2013

33 Comments

 
I have never seen a drug prescribed to so many MS patients over such a short period of time, as I have witnessed with Tecfidera since its marketing release in March 2013. The reasons for the rapid embrace of this therapy by physicians and patients alike are all valid; this is a relatively safe, oral agent with efficacy at least as good as other oral agents and probably better than most injectable therapies (interferons and copaxone).  But this massive prescribing creates one particular problem; both patients and physicians are using this drug without being fully aware of the potential side effects and how to effectively manage them. This can often lead patients to stop treatment prematurely. So I wanted to take some time in this blog to share my experience in helping patients and colleagues manage or prevent side effects from Tecfidera.

The most common side effect of Tecifidera is flushing. If you have ever taken nicotinic acid for high triglyceride levels you know what this means. About 30 minutes to 2 hours after a Tecfidera dose (longer if you take it with food), you may develop redness, warmth and a prickly sensation typically involving the face, chest and arms. This can last for 20 to 30 minutes before subsiding.  Rarely, the flushing can be severe with associated symptoms like your heart racing (palpitations) and chest tightness. Some patients who were not informed of this potential side effect thought they were experiencing an allergic reaction. This side effect can be blocked or minimized (if even necessary to treat) by taking an aspirin (81 to 325 mg) in the morning. If you are unable to tolerate aspirin or allergic to aspirin you can try ibuprofen (eg motrin) or acetomenophen (eg. Tylenol) but they do not tend to work as well as aspirin.  Less commonly, patients experience night sweating after starting Tecfidera.  Many patients have found that an aspirin (81 to 325 mg) at bedtime can minimize this problem.

The potentially more troublesome side effects of Tecfidera involve the gastrointestinal tract. These side effects can be separated into upper and lower GI symptoms.  The upper GI symptoms include nausea and pain in the epigastric region (just below the sternum or breast plate), and are caused by Tecfidera sitting in the stomach too long. Taking Tecidera with food helps but is often not good enough. I have found that a drug called metoclopramide (5 to 10 mg) taken 1 hour before each dose of Tecfidera helps prevent the nausea and clears the drug more quickly from the stomach to prevent pain. If this symptom is a problem for you, make sure you ask your MS specialist about this remedy.  Since most side effects begin when the doctor is not available, I always send patients home with a prescription for metoclopramide to have available if needed.

Lower GI side effects, which include cramping and diarrhea, are equally troublesome. Thankfully, you usually do not need your doctor to help out; simply pick up some over the counter loperamide (the brand name is Imodium) and take 2 mg twice a day until this symptom subsides. If this does not work you may need to contact your MS specialist for a prescription strength medication.

The remarkable thing about Tecfidera is that most of the side effects tend to either disappear or become insignificant after 4 to 8 weeks. It is during this period of time that you may need help managing these symptoms. If the side effects remain problematic for more than 2 months this may not be a good drug for you. When side effects are a problem, they usually disappear within 24 hours of stopping the drug. Certainly, side effects that persist or worsen more than 24 hours after stopping Tecfidera should prompt you to contact your doctor immediately. Often I will have patients experiencing annoying or troublesome side effects stop Tecfidera for a  few days before restarting the medication at a lower dose and gradually increasing to full dose again using the strategies discussed above to prevent a return of the side effects.

As always, every patient situation is different and you should discuss these issues with your doctor before initiating one of the remedies mentioned in this blog.

NOTE:  The medical information on this site is provided as an information resource only, and is not to be used or relied on for any diagnostic or treatment purposes. This information does not create any patient-physician relationship, and should not be used as a substitute for professional diagnosis and treatment.  Please consult your health care provider before making any healthcare decisions or for guidance about a specific medical condition.
33 Comments
Sofia
11/26/2013 01:38:05 am

What does it mean when the flushing persists longer than the 4 to 8 weeks?

Reply
Kinkel
11/26/2013 07:00:19 am

Flushing that persists for more than 4 to 8 weeks doesn't mean anything bad, it's just annoying. Remember, flushing occurs because the active ingredient, mono methylfumarate, binds to nicotinic receptors in the skin. Some people are more sensitive than others but this is not a harmful effect.

Reply
Sofia
12/2/2013 10:09:31 am

That alleviates my concern that it was more than cosmetic.

Mary R
7/12/2014 12:49:44 am

I stopped taking Tefidera two days ago because my stomach pain was so severe and I had a fever, chills and nausea. Today I still feel like I have a virus and severe stomach pain even though my doctor put me on Singulair for stomach pain. Is it possible I have a virus together with reactions from the drug?.

Reply
Howard
9/28/2014 11:00:31 pm

I'm still experenceing night sweating after more than a year and a half on Tecfidera. Any suggestions as I need to be able to sleep better. Otherwise, I'd be fine. Thanks.

Reply
Amy
3/24/2015 02:03:52 am

I am so glad somebody else is having the night sweats and I'm not crazy! Everything else such as hormonal imbalances have been ruled out. I am miserable!! If anybody has suggestions for relief please share!!

Reply
Sabina
9/23/2015 10:27:48 pm

I also have been on tecfidera for 2 years now and I have always had night sweats. Taking tecfidera with food helps alleviate stomach pain.

Reply
Ally
10/17/2015 06:18:25 pm

I have sweats all day long and also find that my body temp is higher now and I occasionally get itchy stinging rash around my chest and neck. If I scratch then it spreads everywhere. A cool shower helps cool my skin rash and temp.

Cheryl Thomas
1/18/2016 06:07:02 pm

Caffeine chocolate or alcohol will enhance night sweats
take a break and see if there is improvement

Reply
Kathy S.
10/4/2014 01:46:11 am

Has anyone experienced heart palpatations / chest tightness on Tecfidera?

Reply
Jenny
11/8/2014 04:42:33 pm

Yes 3 months on TEC and just started heart palpitations this week.

Reply
Nicole
9/6/2015 08:45:46 am

Me too! 3 months in.

Marcie
7/12/2016 10:37:10 pm

That sounds just like my experience. At the worst part it was happening all day. I could monitor my pulse and was skipping one to two beats per min. I tapered my dose down until I speak with my Dr.

R Kinkel
12/28/2014 03:22:06 pm

Although palpitations are not listed in the Tecfidera package insert, it is possible that this is either a rare side effect not recorded during the clinical trials or was included as part of another adverse event symptom complex such as flushing. If you believe that your palpitations are being caused by Tecfidera, please report this immediately to your physician and the food and drug administration at 800-FDA-1088. Palpitations are usually harmless but may indicate a serious underlying condition.

As a general rule whenever you think you are experiencing a side effect to a drug, you should contact your physician. If this side effect has not previously been reported or requires you to visit an emergency room or get admitted to a hospital, this side effect should be reported to the FDA. This is the only way the information will ever become available to other people taking the same medication.

Reply
Nicole
9/6/2015 08:43:53 am

Me! I am having terrible trouble sleeping because of it.

Reply
Tara
10/30/2015 09:26:56 am

Yep I have racing heartbeat and heart pounding so hard it wakes me up at night! It happens to to three times a night and I've only been on texted her for two weeks. It mostly happens 30 minutes to an an hour after I fall asleep and that's only time

Reply
Thérése
11/23/2015 03:03:41 pm

I have! I've been taking Tecfidera during 1,5 weeks and the last couple of dags have experienced this.

Reply
Marcie
7/12/2016 10:35:05 pm

Yes!

Reply
Michauna Davis
7/10/2018 07:45:07 pm

I stopped taking it, and that's when my heart started skipping beats..it did that for a week and then stopped.

Reply
Stephanie M.
12/16/2014 03:58:11 pm

I have been having heart palpitations and am beginning to wonder if it could be related to Tecfidera. Have you asked your neurologist about it? I will call mine tomorrow. They frighten me.

Reply
Kathy S
12/31/2014 01:18:25 am

I did speak with my neurologist. Instead of taking two 240mg tablets a day - he put me on 1 240mg tablet - it seems to have stopped the heart palpitations.

Reply
Arby
8/12/2015 04:05:56 am

I have been taking full dose Tecfidera for two years now. I have terrible night sweats to the point of having to get up and put a dry gown on and sometimes have to change sheets! This side effect started almost immediately after I started using Tecfidera. I have been through menopause so not from that. My doctor put me on a drug holiday for 3 months due to this and other reasons. The night sweats stopped while I was off the drug. I would appreciate any tips on how to handle this very annoying and sleep interrupting side effect.
Right now I am going to bed with frozen cool packs. Helps some but can get very messy.

Reply
Paul
7/30/2016 03:18:29 pm

Has any ever stopped taking there tecfidera how long till symtpoms started happening?

Reply
Amanda
11/8/2016 02:22:05 pm

Hi Paul,
I stopped taking Tecfidera after I noticed a lot of hair loss. I figured I should at least give myself some time to think about other options as I was put on it as soon as I received my diagnosis. I thought about adopting a vegetarian diet since I have read that for many people it has cured them.
I had stopped the Tecfidera for about 2 weeks and then started noticing some symptoms- I was getting dizzy and my right hand started feeling a little bit numb.
I went back on it immediately due to fear. My hair loss has somewhat subsided and those symptoms went away. I did report them to my doctor who then sent me to get an MRI to make sure there was no further brain damage. I still do not have the results, but will let you know.
For all I know, it may have been my nervous system acting up a little as it was coming off of the drugs since they are so powerful and may not have been due to MS. Unfortunately healthcare professionals do not what happens when people stop taking Tecfidera.
I have been researching this topic for a while because I am still considering beginning a veg diet and would like to know what to expect. If you come across any info I would really appreciate it if you shared it on here.
Hope this helps a little.

Reply
Lisa Manocchi
5/20/2017 01:40:09 am

I've been on Tecfidera for 2 years, now I'm getting flushing and flu like symptoms. Anyone else experience this?

Reply
Martha
7/17/2017 04:20:47 pm

Does anyone have flushing on their brain instead of face? Third day on Tec and having this symptom.

Reply
Crystal
6/14/2018 07:40:11 am

I've been on Tecfidera for about a 1 1/2 years and I only have flushing in my head (brain). It only last about 30 seconds, but it feels like my head is on fire.

Brianna Talia
1/1/2018 04:46:20 pm

I have been on Tec for 9 months now and initially had the typical side effects, itching, night sweats, nausea, cramping, migraines and flushing. It's been a few months on the full dose and I still experience the night sweats and migraines frequently and have suddenly began flushing again every evening for almost the whole month of December. My cheeks, nose, ears, arms and chest all turn bright red, feel REALLY hot and begin to itch. Oddly, the flushing is happening about 8 to 10 hours after my first dose and about two hours before I take my second dose? From what I have read most people experience it shortly after taking dose so not sure why my flushing is so delayed?

I also get an occasional fever and feel extremely fatigued for multiple days at a time. My neurologist put me on Amantadine to help my energy levels but I haven't noticed any difference when I take it versus when I don't. I started a new job 6 months ago and have missed 6 days of work already due to fatigue, fever and barely being able to even leave my bed. I have also left early a few days due to horrible migraines... My specialist says it doesn't seem to be my MS and that it may just be side effects from Tecfidera and should subside eventually. Anyone else having similar issues? Please tell me this gets better!

Reply
Nyki
7/24/2017 09:56:22 am

I have been on Tecfidera for a little over a year. I get the flushing and Dry Mouth but as long as I eat heavy carbs like a sub with it, the flushing and dry mouth isn't so bad. Over the past 2 months I have been experiencing chest tightness/chest pain/palpitations or something like that. My mom thinks I'm just having anxiety. but I take anxiety meds and also baby aspirin. Sometimes the tightness stops and sometimes it doesn't. My neurologist doesn't think it has to do with the tecfidera. And has referred me to my primary doctor to see what she thinks and if I need to go to a heart doctor. Anyone else having these types of issues?

Reply
Anna Schotte
7/25/2017 12:02:31 am

I've been on Tecfidera for almost three years now and have been free from relapses. Had severe stomach problems for a month and had to stay longer on the lower dose. I experience some flushes and itching (and also a running nose) but it has never bothered me. I was never informed that the drug could cause night sweats and I am now quite relieved to hear that I'm not alone. I am usually really frozen when I go to bed but wake up all sweaty. Seems like I have not had a full night's sleep for a very long time. I am also experiencing severe tiredness, something I thought was the MS fatigue but when I read comments from other Tec users I understand that this is quite common. I will now try to take the night pill at around 6 pm in order to have the effect of sweating a bit earlier. Taking an Aspiring every night does not seem like a healthy option. Taking vitamine D and selen every day and will start with vitamine B12. Trying to go to the gym every day but it is hard after a a full day's work with with this extreme tiredness. If anyone has any suggestions as when to best to take Tec during the day, please let me know, thank you!

Reply
Cate link
9/12/2017 09:52:15 am

I started Tecfidera in November after a severe reaction to Plegridy. The stomach issues lessened after a month but still come and go. Flushing never stopped. I found aspirin was necessary with the morning pill or 2 hours later I would have severe flushing (zyrtec seemed to help alleviate this symptom when I missed the aspirin).

10 days ago I missed Tecifidera on accident. The next day I decided I didn't want to take it anymore. I wanted to feel better. I feel fine but reality kicked in. Tec wasn't fixing the symptoms but preventing further damage. I restarted it today. Not sure if I should try once a day for a few days then go back to twice. Or, just resume.

Yes, I know foolish to stop but being "normal" for one week was nice.

Reply
Ashley lowry
2/23/2020 09:52:42 am

This is my second day on tecfidera, and i have had a few minor symptoms, nothing to bad ,but i have notice that im getting out of breath ,and breathing harder..has anyone els had this ??

Reply
Revere Kinkel MD
2/24/2020 08:03:03 am

Shortness of breath would not be considered a typical side effect of this Tecfidera. Shortness of breath does suggest a possible allergic reaction. You should temporarily stop it and contact your doctor immediately.

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