Tecfidera
Generic name: dimethyl fumarate [ dye-METH-il-FUE-mar-ate ]
Drug class: Selective immunosuppressants
What is Tecfidera?
Tecfidera is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).
Tecfidera is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate.
It is not known if Tecfidera is safe and effective in children under 18 years of age.
Warnings
Before taking and while you take Tecfidera, tell your doctor if you have or have had a low white blood cell counts or an infection.
Tecfidera may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.
Before taking this medicine
You should not use Tecfidera if you have had a severe allergic reaction to dimethyl fumarate or diroximel fumarate (Vumerity).
To make sure Tecfidera is safe for you, tell your doctor if you have ever had:
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an active infection; or
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low white blood cell (WBC) counts.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dimethyl fumarate on the baby.
Tecfidera is not approved for use by anyone younger than 18 years old.
How should I take Tecfidera?
Take Tecfidera exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Tecfidera.
You may take Tecfidera with or without food. Taking the medicine with food may help prevent flushing (sudden warmth, redness, or tingly feeling).
Swallow the capsule whole and do not crush, chew, break, or open it.
While using this medicine, you will need frequent blood tests.
Store this medicine in the original container at room temperature, away from moisture, heat, and light.
Dosing information
Usual Adult Dose for Multiple Sclerosis:
Initial dose: 120 mg orally twice a day for 7 days
Maintenance dose: 240 mg orally twice a day
Approved indication: The treatment of patients with relapsing-remitting multiple sclerosis.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Tecfidera side effects
Get emergency medical help if you have signs of an allergic reaction to Tecfidera: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Dimethyl fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
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symptoms of herpes virus - flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back;
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low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
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liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Tecfidera side effects include:
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stomach pain, indigestion, nausea, vomiting, diarrhea;
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redness, rash, itching; or
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flushing (sudden warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Tecfidera?
Other drugs may interact with dimethyl fumarate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Popular FAQ
Yes, Tecfidera does suppress the immune system. Although experts are not sure exactly how Tecfidera does this, Tecfidera has been associated with reductions in lymphocyte counts, and several serious opportunistic viral infections, such as progressive multifocal leukoencephalopathy and herpes zoster, as well as uncommon fungal and bacterial infections. Continue reading
Vumerity and Tecfidera are administered in the same way and used to treat the same condition, multiple sclerosis (MS). They also have the same active metabolite, which means that they have the same therapeutic effect - work the same way - in people with MS.
However, Vumerity and Tecfidera do have different chemical structures and Vumerity is better tolerated and causes fewer gastrointestinal problems compared with Tecfidera. Continue reading
There does not appear to be any rebound disease repercussions associated with stopping Tecfidera abruptly, unlike some other MS drugs such as Tysabri or Gilenya. Studies have shown the majority of patients taking Tecfidera discontinue or switch to another treatment within two years. Continue reading
40% of people report flushing as a side effect of Tecfidera and although experts aren’t sure how Tecfidera causes flushing they suggest it may be due to one of the pathways affected by Tecfidera called HCAR2. When the metabolite of Tecfidera, MMF binds to HCAR2, it induces prostanoid-forming enzymes in different cell types. These enzymes form prostaglandins which, in addition to other effects, signal capillaries to open, which causes flushing. Continue reading
Although there is no direct interaction between alcohol and Tecfidera (dimethyl fumarate), you should not drink excessive quantities of alcohol while you are taking Tecfidera, because it may increase the risk of side effects such as inflammation of the stomach (gastritis), especially in those with a history of stomach problems. You should avoid drinking alcohol, especially strong spirits, for at least an hour after taking Tecfidera; however, one glass of alcohol, now and then at a different time of day to your Tecfidera dose is considered OK. Continue reading
Tecfidera can be taken for as long as it continues to have a clinical benefit and you are not experiencing intolerable or severe side effects. Continue reading
Gilenya and Tecfidera are both disease-modifying oral medications approved for the treatment of MS. Both are equally effective although Tecfidera is more likely than Gilenya to be discontinued within 24 months. Gilenya is approved to treat adults and children aged 10 and older and Tecfidera is only approved for adults over the age of 18. Common side effects of Gilenya include heart rhythm disturbances, diarrhea, infections, and elevations in liver enzymes and common side effects of Tecfidera include flushing, gastrointestinal disturbances, and infections. Tecfidera is slightly more expensive than Gilenya. Continue reading
88% of patients taking Tecfidera are likely to report stomach-related adverse effects, including upper abdominal pain, nausea, and flatulence. These side effects tend to be more common in the first three weeks of treatment and overall, 54% took some form of treatment for the side effects. Tecfidera is unlikely to cause permanent stomach damage. Continue reading
Weight gain or weight loss is not a recognized side effect of Tecfidera and it is not documented in the prescribing information for Tecfidera which reports side effects that occur in clinical trials at a 2% higher incidence than placebo. However, anecdotally blog sites report weight gains with Tecfidera of anywhere from 5-6lbs to up to 25 pounds, but there are also people who report weight loss of up to 14 pounds. Continue reading
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Tecfidera only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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