What Tecfidera is used for and how to use it
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Tecfidera - Consumer Medicine Information

Manufacture: Biogen Inc.
Country: Canada
Condition: Multiple Sclerosis
Class: Selective immunosuppressants
Form: Capsules
Ingredients: dimethyl fumarate, 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, triethyl citrate

TECFIDERA

Dimethyl fumarate

About this Medication

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

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.

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.

Overdose

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 and what to do about them

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.

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.

  • 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.

Serious side effects, how often they happen and what to do about them

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
seek
emergency
medical assistance
Only
if
severe
In all
cases
CommonFlushing
(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)
UncommonAllergic reaction
(symptoms
include rash,
itching, difficulty
breathing,
swelling of the face,
lips,
tongue or throat)
RareProgressive
multifocal
leukoencephal-
opathy (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.

How to Store it

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.

Reporting Suspected Side Effects

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:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      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
www.healthcanada.gc.ca/medeffect.

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.

More Information

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