TecGistry, the TECFIDERA® (dimethyl fumarate) Pregnancy Exposure Registry

If you become pregnant while taking TECFIDERA or were taking TECFIDERA since your last menstrual period prior to becoming pregnant, it is important for you to know about this pregnancy registry and how you can participate. 

You may have asked yourself whether your relapsing MS and the medication you take will affect your baby 

The effects of a particular medicine on the health of a baby are often unknown because pregnant women are not usually included in studies where a potential new medicine is being tested. Pregnancy registries aim to collect information that could help women in the future and their doctors make more informed decisions about using a particular medicine during pregnancy. Click here to learn more about relapsing MS and pregnancy. 

Learn how you can help. This is a global registry for women who are pregnant and have taken TECFIDERA. Information about health during pregnancy will be collected from participants and their doctors; information on the health of their babies will also be collected from the baby’s doctor. In the future, other pregnant women who are exposed to TECFIDERA may have more information as a result of this registry about how their pregnancies and babies may or may not be affected. Find out how to take part.


What the medication is used for:

TECFIDERA®  is a prescription medication to treat relapsing remitting multiple sclerosis (MS). TECFIDERA does not cure MS, but helps to reduce the number of flare-ups (relapses) that occur and slow the build-up of physical problems due to MS (disability progression).

What it does:

TECFIDERA may work by changing the way the body’s immune system works, to help keep it from further damaging your brain and spinal cord.

When it should not be used:

Do not take TECFIDERA if you:

Have an allergy or are sensitive to dimethyl fumarate or any ingredients in this medicine.

TECFIDERA should not be used in children and adolescents under 18 years, because it has not been studied in MS patients younger than 18 years of age.

What the medicinal ingredient is:

Dimethyl fumarate.

What the nonmedicinal ingredients are:

Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer (type A), methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, silicified microcrystalline cellulose, simethicone, sodium lauryl sulfate, talc, and triethyl citrate.

The capsule shell contains black iron oxide, FD&C Blue 1, gelatin, titanium dioxide, and yellow iron oxide.

What dosage forms it comes in:

Delayed-release capsules: 120 mg and 240 mg.


BEFORE you use TECFIDERA®  talk to your doctor or pharmacist if:

  • You have or have had low white blood cell counts (low lymphocytes). Low lymphocyte counts may be caused by another illness that affects the immune system (for example, immunodeficiency syndrome), bone marrow transplantation, or other treatments that can suppress the immune system.
  • You have an infection.
  • You have liver or kidney disease.
  • You have a disease of the stomach or bowel.
  • You are pregnant or planning to become pregnant.
  • You are breast-feeding.


You should tell your doctor(s) if you are taking any other prescription or non-prescription medicines. This includes any vitamin or mineral supplements, or herbal products.

  • Fumaric acid. Do not use TECFIDERA®  with other types of fumaric acid. Ask your doctor or pharmacist if you are not sure what other products may contain fumaric acids.
  • Medicines that affect the immune system including some commonly used cancer treatments and other medicines used to treat MS, such as, natalizumab, fingolimod, or mitoxantrone. TECFIDERA should not be started while you are on other MS medications. If you stop taking one of these medicines to switch to TECFIDERA you may be required to wait before starting TECFIDERA. The amount of time you may need to wait will vary, depending on the treatment. Your doctor will know how long you may need to wait.
  • Medicines that can affect the kidneys, such as antibiotics from the aminoglycoside class, non-steroidal anti-inflammatory drugs (NSAIDs), diuretics, or lithium. TECFIDERA has not been studied in patients who take these drugs regularly.
  • Vaccines. During treatment with TECFIDERA, administration of vaccines containing live virus is not recommended.
  • Oral contraceptives. TECFIDERA may make oral contraceptives less effective. Consider using an extra form of contraception while you are taking TECFIDERA.


Always follow your doctor’s instructions for taking TECFIDERA® . You should check with your doctor or pharmacist if you are not sure.

Swallow whole. Do not divide, crush, dissolve, suck, or chew the capsule.

TECFIDERA can be taken with or without food.

TECFIDERA capsules are packaged in a folding blister card inside a carton. Remove the capsules from the blister by pushing them through the foil.

Your doctor may reduce your dose if you have certain side effects. Do not reduce your dose unless your doctor tells you to.

Usual adult dose:

Starting dose: one 120 mg capsule twice a day (one in the morning and one in the evening).

Starting total daily dose: 240 mg a day.

Take this starting dose for the first 7 days, and then take the regular dose.

Regular dose: one 240 mg capsule twice a day (one in the morning and one in the evening).

Regular total daily dose: 480 mg a day.


If you have taken more TECFIDERA than your doctor has recommended, contact a regional Poison Control Centre immediately and a health care practitioner, or go the nearest hospital emergency department even if there are no symptoms. Take the medication package with you when you go to the hospital.

Missed Dose:

If you forget or miss a dose, do not double your next dose.

You may take the missed dose if you leave at least 4 hours between the morning and evening doses, otherwise wait and take your next dose as planned.


Side effects may include:

Flushing and stomach upset. People are more likely to have these side effects when they first start taking TECFIDERA® (mostly during the first month). Most people have mild to moderate symptoms and they tend to go away over time.

If you become flushed and get swelling of the face, lips, mouth or tongue, wheezing, difficulty breathing or shortness of breath, stop taking TECFIDERA and seek emergency medical assistance.

Signs of stomach upset may include:

  • Diarrhea
  • Nausea (feeling like you are going to be sick)
  • Stomach pain or stomach cramps
  • Vomiting (throwing up)
  • Indigestion.

Talk to your doctor about how to manage these side effects. Your doctor may reduce your dose. Do not reduce your dose unless your doctor tells you to.

Taking TECFIDERA with food may help manage these side effects. Your doctor may recommend taking an over-the-counter pain and fever reducer, such as aspirin, for a few days to manage signs of flushing.

TECFIDERA can cause abnormal blood and urine test results, including decreases in your white blood cell count. Your doctor will decide when to perform blood and urine tests and will interpret the results.

  Talk with your doctor or pharmacist    


Only if severe

In all cases

Stop taking drug and seek emergency medical assistance


Flushing (symptoms of severe flushing may include general swelling, rash, itchiness)  

Gastrointestinal (GI) events (symptoms include diarrhea, nausea, stomach pain, vomiting, indigestion) 

Low levels of white blood cells (lymphocytes) (symptoms may include serious infections, e.g. pneumonia, or being more prone to infections) 


Proteins (albumin) in urine (symptoms may include swelling of the face or legs) 

  Increased levels of liver enzymes (ALT, AST) in the blood (symptoms may include loss of appetite, fatigue, yellowing of the skin or eyes, or dark urine)     ✔  
 Uncommon Allergic reaction (symptoms include rash, itching, difficulty breathing, swelling of the face, lips, tongue or throat) 
 Rare Progressive multifocal leukoencephalopathy (PML), a rare brain infection (symptoms may include: progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes)

This is not a complete list of side effects. For any unexpected effects while taking TECFIDERA, contact your doctor or pharmacist.


Store TECFIDERA®  at room temperature (between 15 to 30 °C).

Protect TECFIDERA  from light. Store the capsules in their original packaging. Do not take your medicine after the expiry date shown on the carton. Keep out of reach and sight of children.

Medicines should not be disposed of in waste water or household garbage. Ask your pharmacist how to dispose of medicines you no longer need.


You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Health Canada

Postal Locator 0701E

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.


This document plus the full product monograph, prepared for health professionals can be obtained by contacting Biogen Canada Inc., at: 1-855-MSONE-00 (1-855-676-6300).