TM Owner Biogen
Tecfidera 240mg Capsule
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Indications & Clinical Uses
- Tecfidera 240 mg delayed-release capsules contain dimethyl fumarate, an oral disease-modifying therapy for multiple sclerosis (MS) that works partly through the Nrf2 antioxidant pathway.
- In the US it is approved for adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease; the EU label covers relapsing-remitting MS specifically but extends down to age 13.
- Treatment starts with a one-week titration dose of 120 mg twice daily before increasing to the maintenance dose of 240 mg twice daily.
- Generic dimethyl fumarate capsules are available in some markets; diroximel fumarate (Vumerity), a related but chemically distinct prodrug, is not the same medicine and is not interchangeable with Tecfidera.
- Manufactured by Biogen, Tecfidera is self-administered orally at home and is not given by injection or infusion.
Side Effects
- The most common side effects, occurring in more than 1 in 10 people, are flushing (often with skin redness, warmth or itching, especially in the first month) and gastrointestinal problems including abdominal pain, diarrhea and nausea; taking capsules with food can reduce both.
- Tecfidera has no boxed warning, but it can lower white blood cell counts (lymphopenia), which increases infection risk and has been linked to rare cases of progressive multifocal leukoencephalopathy (PML), a serious brain infection; blood counts are checked before starting and periodically during treatment.
- Serious but rare risks include liver injury with elevated liver enzymes, severe allergic reactions (anaphylaxis, angioedema) and gastrointestinal problems including perforation.
- Seek urgent care for a severe skin reaction, facial or throat swelling, unusual weakness, confusion, vision changes, or persistent fever suggesting infection.
Precautions & Warnings
- A complete blood count is checked before starting Tecfidera and at least annually during treatment, along with periodic liver function tests; treatment is stopped if lymphocyte counts fall persistently below 0.5x10^9/L or if PML is confirmed or suspected.
- Tecfidera is contraindicated in known hypersensitivity to dimethyl fumarate or its capsule ingredients.
- It has not been shown to reduce antibody responses to non-live vaccines, but discuss any vaccination plans, especially live vaccines, with your neurologist, particularly if lymphocyte counts are low.
- A pregnancy exposure registry has recorded outcomes in exposed pregnancies; use in pregnancy should be individualized with your healthcare provider, weighing MS relapse risk against any possible fetal risk.
- Avoid driving if flushing, dizziness or gastrointestinal symptoms are severe enough to impair concentration.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you use.
- Tecfidera has not shown clinically relevant interactions through the cytochrome P450 liver enzyme system, giving it a relatively low interaction burden compared with many other MS therapies.
- Using Tecfidera together with other medicines that suppress the immune system or bone marrow, including other fumarate products or long-term systemic corticosteroids, may increase the risk of low white blood cell counts and infection, and is generally avoided.
- Taking aspirin roughly 30 minutes before a dose may reduce flushing for some patients; discuss this with your healthcare provider first.
- Swallow capsules whole with food if flushing or stomach symptoms are troublesome, and never crush, chew or open them.
References
Frequently Asked Questions
Tecfidera (dimethyl fumarate) is an oral capsule that treats relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome and relapsing-remitting disease. In the EU it is approved from age 13; in the US it is approved for adults only. It reduces immune-driven inflammation in the brain and spinal cord.
Tecfidera is a delayed-release capsule swallowed whole, twice daily, with or without food. Treatment starts at 120 mg twice daily for one week, then increases to the maintenance dose of 240 mg twice daily. Do not crush, chew or open the capsules.
The most common Tecfidera side effects, affecting more than 1 in 10 people, are flushing and stomach problems like abdominal pain, diarrhea and nausea, usually easing within the first month. Taking capsules with food helps. Rare but serious risks include low white blood cells, liver problems and severe allergic reactions.
Tecfidera has few major drug interactions, but avoid combining it with other immune-suppressing medicines, which can worsen low white blood cell counts. Blood tests are needed before starting and at least yearly after. Discuss any live vaccines with your neurologist first, especially if your lymphocyte count is low.
If you miss a dose, take it as soon as you remember unless it is close to your next dose; do not double up. Skip the missed dose if several hours have passed and resume your normal twice-daily schedule at the next planned time.
Tecfidera can lower white blood cell counts (lymphopenia), which raises infection risk and, rarely, a serious brain infection called PML (progressive multifocal leukoencephalopathy). Your neurologist checks blood counts before starting and at least once a year during treatment to monitor this risk.
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