Tecfidera Capsules is a brand of medicine containing the active ingredient dimethyl fumarate.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
dimethyl fumarate (dy-mee-thial-fuma-rate)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about TECFIDERA capsules.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the benefits TECFIDERA is expected to have for you against the risk of using it.
Your doctor will discuss the benefits and risks of using TECFIDERA with you before you start treatment.
If you do not understand anything your doctor has told you, please ask your doctor again
If you have any questions about using this medicine, ask your doctor, nurse or pharmacist.
What it is used for
What TECFIDERA is used for
TECFIDERA is used to treat relapsing multiple sclerosis (MS).
TECFIDERA is available only with a doctor’s prescription.
Ask your doctor if you have any questions about why TECFIDERA has been prescribed for you.
TECFIDERA is to be given only to the person for whom it has been prescribed.
TECFIDERA has not been tested in clinical trials in people with MS who are below 18 years of age or above 65 years of age. TECFIDERA has not been studied in patients with chronic progressive MS.
How it works
TECFIDERA slows down the progression of physical disability in people with relapsing forms of MS and decreases the number of flare ups (relapses).
Some people feel better when they start to take TECFIDERA. However TECFIDERA cannot repair damage that has already been caused by MS. When you start TECFIDERA you might not notice an improvement, but TECFIDERA may still be working to help prevent your MS from becoming worse.
The cause of MS is not yet known, MS affects the brain and spinal cord. In MS, the body’s immune system reacts against its own myelin (the ‘insulation’ surrounding nerve fibres). In relapsing forms of MS, people have ‘exacerbations’ from time to time (eg blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). They are followed by periods of recovery. Recovery may be complete or incomplete. If it is incomplete there is ‘progression of disability’.
TECFIDERA contains the active ingredient dimethyl fumarate. Dimethyl fumarate decreases the inflammation in your brain that is caused by MS and thereby reduces nerve damage.
TECFIDERA works by reducing inflammatory responses in cells and helps to protect the central nervous system cells against attack. Inflammation of the brain is an important part of the MS disease process.
Before you are given it
When you must not be given it
Do not use TECFIDERA if you have had an allergic reaction to dimethyl fumarate or any other ingredients listed at the end of this leaflet.
Symptoms of allergic reactions may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
Do not use TECFIDERA if you are being treated with other medicines containing fumaric acid (creams or tablets/capsules)
TECFIDERA must not be used after the expiry date.
If you are not sure whether you should use this medicine, talk to your doctor or pharmacist.
Before you are given it
Tell your doctor if you have had:
- Allergies to any other medicines, foods or, preservatives or dyes
- Liver problems
- Kidney problems
- Previous treatment with TECFIDERA
- An infection
- Recently received a vaccination
Tell your doctor if you are pregnant or intend to become pregnant. There is no information on the use of TECFIDERA during pregnancy. Your doctor will discuss the risks of and benefits of using TECFIDERA if you are pregnant.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known whether TECFIDERA can pass into breast milk. Your doctor will help you decide whether you should stop breast-feeding, or stop using TECFIDERA. This involves balancing the benefit of breast-feeding for your child, and the benefit of therapy for you.
If you have not told your doctor about any of the above, tell him/her before you start using TECFIDERA.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any prescribed by other doctors or that you buy without a prescription from a pharmacy, supermarket or health food shop. In particular tell your doctor if you are being treated with any medicine that affects immune function.
There are many medicines that can affect immune function. It is a good idea to keep a list of your medicines and take it with you when you go to your doctor.
Tell your doctor if you are taking any medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar anti-inflammatories and medicines purchased without a doctor’s prescription) and medicines that contain lithium.
Ask your doctor, nurse or pharmacist if you have any questions about medicines to be careful with or avoid while using TECFIDERA.
How to take it
How much to take
The recommended starting dose of TECFIDERA is 120 mg given twice daily. After 7 days the recommended dose is 240 mg twice daily.
How to take it
Swallow each capsule whole with a glass of water. Do not crush, divide or dissolve the capsule or its contents.
When to take it
TECFIDERA can be taken with or without food. For those patients who experience gastrointestinal side effects or flushing, taking TECFIDERA with food may help reduce these effects.
How long to use it
The positive effects of TECFIDERA may not be seen immediately. They occur with long term treatment. It is important to continue treatment with TECFIDERA unless your doctor tells you to stop.
It is important not to interrupt treatment with TECFIDERA.
If you forget to use it
If you miss a capsule you should take it as soon as possible, unless your doctor has told you otherwise. Do not try to make up for missed doses by taking more than one dose at a time.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else has may have taken too much TECFIDERA. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking it
If you are about to have any blood tests, tell your doctor that you are using TECFIDERA. TECFIDERA may decrease lymphocyte (white cell) counts that will show up in results of a full blood count. Before you start TECFIDERA, your doctor will do a blood test to count the number of your white blood cells. Your doctor will test these periodically during treatment.
Take TECFIDERA exactly as your doctor has prescribed.
Speak to your doctor as soon as possible if you notice any new or worsening medical conditions e.g., fever or infection.
Tell your partner or caregiver about your treatment.
If you become pregnant while on treatment with TECFIDERA immediately tell your doctor.
Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.
If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using or have used TECFIDERA. Tell your doctor if you are going to be vaccinated.
Urine tests will also be carried out before and periodically during treatment.
Tell your doctor as soon as possible if you do not feel well while using TECFIDERA.
TECFIDERA may cause unwanted side effects in some people. All medicines have side effects. Sometimes they are serious, most of the time they are not.
Do not be alarmed by the lists of side effects. You may not experience any of them.
Tell your doctor, nurse or pharmacist to answer any questions you may have.
Tell your doctor nurse or pharmacist if you notice any of the following and they worry you:
- Hot flush (feeling hot, redness)
- Itchy rash
- Burning sensation (skin)
- Feeling sick (nausea)
- Abdominal pain
The above list includes the more common side effects of TECFIDERA. If any of these persist or worsen, talk to your doctor as they may also be due to an infection or allergic reaction.
Tell your doctor as soon as possible if you notice the following:
- Signs of infection (e.g., unexplained fever, severe diarrhoea)
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
Speak to your doctor immediately if you notice any of the following after taking TECFIDERA.
- Swelling of your face, lips, tongue or other parts of the body.
- Shortness of breath, wheezing, difficulty breathing, chest pain or discomfort.
These are very serious side effects. If you have them you may be having a serious allergic reaction to TECFIDERA. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects, which are not listed, may occur in some patients.
Ask your doctor to answer any questions you may have.
After being given it
Keep TECFIDERA capsules in its packaging until you are ready to take each capsule.
Keep TECFIDERA below 30°C.
Do not store TECFIDERA or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines.
Keep TECFIDERA where children cannot reach it.
If your doctor tells you to stop taking TECFIDERA or you find that the expiry date has passed, ask your pharmacist what to do with any capsules you have left.
What it looks like
TECFIDERA (dimethyl fumarate) capsules are available in two strengths: 120 mg and 240 mg.
- The 120 mg capsules are green and white printed with ‘BG-12, 120 mg’ in black ink on the capsule body. Available in blister wallet cards containing 14 or 112 capsules packed in a box.
- The 240 mg capsules are green printed with ‘BG-12, 240 mg’ in black ink on the capsule body. Available in blister wallet cards containing 14or 56 capsules packed in a box.
Not all pack sizes may be marketed.
- Dimethyl fumarate 120 mg per capsule.
- Dimethyl fumarate 240 mg per capsule.
- Microcrystalline cellulose (E460)
- Croscarmellose sodium (E468)
- Purified talc (E553b)
- Colloidal anhydrous silica (E551)
- Magnesium stearate (E572)
- Triethyl citrate (E1505)
- Methacrylic acid copolymer
- Sodium lauryl sulfate (E514),
- Polysorbate 80 (E433),
- Titanium dioxide (E171),
- Brilliant blue FCF CI42090 (E133),
- Iron oxide yellow CI77492 (E172),
- Iron oxide black CI77499 (E172).
You can obtain more information from your doctor, pharmacist or the MS Society in your State, or by telephoning the MS Alliance on 1800 852 289 in Australia.
Biogen Idec Australia Pty Ltd
Suite 1, Level 5 123 Epping Road
North Ryde NSW 2113
Australian Registration Numbers:
TECFIDERA 120 mg - AUST R 197118
TECFIDERA 240 mg - AUST R 197119
This leaflet was prepared in February 2014.
TECFIDERA® is a registered trademark of Biogen Idec.
BIOGEN IDEC® is a registered trademark of Biogen Idec MA Inc.
CMI provided by MIMS Australia, July 2016