How does this medication work? What will it do for me?
Dimethyl fumarate is a medication that acts on the central nervous system (the brain and spinal cord). It is used to reduce how often the symptoms of relapsing-remitting multiple sclerosis (MS) occur and to slow down the progression of disability. In the relapsing-remitting form of MS, attacks of symptoms (relapses) are followed by periods when the symptoms go away completely or partially (remissions).
MS is believed to be a disease where the body creates inflammation that damages the cells in the central nervous system. When the cells in the nervous system are damaged, the ability of the brain to send messages to the rest of the body is reduced. Although it is not completely clear how it works, dimethyl fumarate may work by changing the way the immune system works, to help prevent further damage to the cells in the brain and spinal cord.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each capsule with a green cap and white body, printed with "BG-12 120 mg" in black ink, is filled with enteric-coated microtablets containing dimethyl fumarate 120 mg. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, talc, colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer (type A), methacrylic acid copolymer dispersion, simethicone, sodium lauryl sulfate, and polysorbate 80. The capsule shell contains gelatin, titanium dioxide, FD&C Blue 1, yellow iron oxide, and black iron oxide.
How should I use this medication?
The usual starting dose of dimethyl fumarate is 120 mg taken twice a day. This is taken for the first 7 days and then the dose is increased to 240 mg (two 120 mg capsules) taken twice a day.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
Dimethyl fumarate may be taken with or without food. If you experience flushing, take the medication with food to reduce this effect.
Swallow the capsules whole with water or another fluid. Do not divide, crush, dissolve, suck, or chew on the capsule.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 4 hours before your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to dimethyl fumarate or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- flushing (e.g., becoming red in the face or body, feeling warm or hot, itchiness or burning sensation)
- stomach pain or cramps
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- signs of infection (including fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, or unexplained weight loss)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of protein in the urine (e.g., swelling of the face or legs)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., difficulty breathing, rash, or swelling of the face, lips, tongue, or throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
[February 6, 2015]
Health Canada has issued new restrictions concerning the use of TECFIDERA ® (dimethyl fumarate). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, or unexplained weight loss. Your doctor will do blood tests regularly to monitor your white blood cell count.
Kidney function: Treatment with dimethyl fumarate may cause an increase in the amount of protein removed from the body by the kidneys. In some cases, this may indicate a decrease in kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your kidney function regularly while you are taking this medication.
Tell your doctor immediately if you experience symptoms of protein in the urine, such as swelling of the face or legs.
Liver function: Treatment with dimethyl fumarate may cause an increase in liver enzymes, which are chemicals produced by the liver. In some cases, increased liver enzymes can indicate a decrease in liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
Tell your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, tell your doctor immediately.
Breast-feeding: It is not known if dimethyl fumarate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children below the age of 18.
Seniors: Seniors are more likely to have medical conditions that may be affected by dimethyl fumarate. If you are a senior and taking this medication, your doctor should closely monitor your medical conditions while you are taking this medication.
What other drugs could interact with this medication?
There may be an interaction between dimethyl fumarate and any of the following:
- aminoglycoside antibiotics (e.g., gentamicin, tobramycin)
- anti-cancer medications (e.g., mitoxantrone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide)
- fumaric acid
- live vaccines (e.g., yellow fever vaccine, chickenpox vaccine)
- mycophenolate mofetil
- non-steroidal anti-inflammatory medications (NSAIDs; e.g., ibuprofen, ketorolac, naproxen)
- other medications for MS (e.g., fingolimod, natalizumab)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tecfidera