Gilenya vs Tecfidera. How do they compare?
Both Gilenya and Tecfidera are oral medications that may be used to treat relapsing forms of multiple sclerosis (MS), which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. There are several differences and similarities between them.
What are the differences between Gilenya and Tecfidera?
There are several differences between Gilenya and Tecfidera.
- Gilenya is a brand (trade) name for fingolimod and Tecfidera is a brand (trade) name for dimethyl fumarate.
- Gilenya is marketed by Novartis and Tecfidera is marketed by Biogen.
- Gilenya is approved to treat MS in adults and children over the age of 10; however, Tecfidera is only approved to treat MS in adults over the age of 18.
- Gilenya is an oral capsule that is taken once daily and Tecfidera is a delayed-release oral capsule that is taken twice daily.
- Gilenya works by works by blocking the migration of lymphocytes (a type of immune cell) from the lymph nodes into the bloodstream. Although it is not exactly known how Gilenya exerts its effects in multiple sclerosis it may be due to a decrease in the migration of lymphocytes into the brain and spinal cord (central nervous system). This reduces nerve inflammation and damage.
- Experts are not sure exactly how Tecfidera (dimethyl fumarate) works but there is evidence that it activates a pathway that is involved in oxidative stress, called the Nrf2 (Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway. A metabolite of Tecfidera, monomethyl fumarate (MMF), acts as a nicotinic acid receptor agonist which can affect nerve firing. Research has shown Tecfidera reduces inflammation and protects nerve cells from damage caused by the immune system attacking the myelin sheath.
- Before prescribing Gilenya, a doctor needs to obtain a cardiac evaluation, complete blood count (CBC), liver function tests, review any existing medications, and test for antibodies to varicella-zoster virus. Before prescribing Tecfidera, a doctor needs to obtain a CBC and patients should be warned to expect flushing and gastrointestinal side effects.
- Although not listed as a side effect in the product information, blog posts suggest weight gain is more common with Gilenya than Tecfidera; however it has been reported with both drugs.
- Hair loss is an uncommon side effect of Gilenya, reported in 3% of patients (compared with 2% of those taking placebo) but is not a recognized side effect of Tecfidera; although, anecdotally some people report losing hair.
- Other common side effects with Gilenya include heart rhythm disturbances, back pain, diarrhea, and increased liver enzymes. Common side effects of Tecfidera include flushing and gastrointestinal effects (such as abdominal pain, nausea, diarrhea, and flatulence).
- Few trials comparing Gilenya to Tecfidera have been conducted; however, one showed similar rates of effectiveness in MS, although Tecfidera was more likely to be discontinued (44% of patients discontinued Tecfidera within 24 months compared with 35% of patients taking Gilenya).
- There is a risk that MS symptoms may worsen if you stop taking Gilenya, although this effect is rare, with only 35 known cases documented over 8 years. Worsening MS symptoms (more than what would be expected for a progressive disease) do not appear to be associated with Tecfidera discontinuation.
What are the similarities between Gilenya and Tecfidera?
There are also many similarities between Tecfidera and Gilenya, including:
- Both are considered disease-modifying therapies (DMTs)
- Both may be taken with or without food; however, flushing is less if Tecfidera is taken with food and with enteric-coated aspirin (up to a dose of 325mg). Both Gilenya and Tecfidera should be swallowed whole and not crushed, chewed, or opened
- Both suppress the immune system and will reduce a person’s ability to fight infection and decrease the immune response to live vaccines, such as MMR and chickenpox vaccines
- Gilenya reduces lymphocyte counts because of the way it works in the body; however, Tecfidera can also decrease lymphocyte counts by a different mechanism and pronounced lymphocytopenia (decreased lymphocytes) of below 500/µl have been reported in 4–6% of patients
- Both are expensive. Gilenya costs approximately $4790 for a month’s supply and Tecfidera costs approximately $5320. Costs may vary depending on insurance plans or the pharmacy you visit
- Neither Gilenya nor Tecfidera will cure MS, but they are both effective at decreasing symptoms and the frequency of a relapse
- Neither has a low-cost generic.
- Vollmer B, Ontaneda D, Bandyopadhyay A, et al. Discontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers. Neurol Clin Pract. 2018;8(4):292-301. DOI:10.1212/CPJ.0000000000000487
- Tecfidera, Gilenya Equally Effective, But More MS Patients Stop Tecfidera, Real-World Study Shows Aug 30th, 2018. Multiple Sclerosis News Today https://multiplesclerosisnewstoday.com/2018/08/30/tecfidera-gilenya-equally-effective-but-more-ms-patients-stop-tecfidera-study/
- Gilenya (fingolimod) [Package Inserts]. Novartis Pharmaceuticals Corporation https://www.drugs.com/pro/gilenya.html
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