Tecfidera (Dimethyl Fumarate)
Tecfidera (dimethyl fumarate) Dosage and Side Effects
TECFIDERA is a prescription medication to treat relapsing remitting multiple sclerosis (MS).
Warnings and Precautions
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.
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:
- Nausea (feeling like you are going to be sick)
- Stomach pain or stomach cramps
- Vomiting (throwing up)
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.
Interactions with this medication
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.
Proper Use of this medication
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.
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.
Other related products
The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.