Tecfidera
dimethyl fumarate
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Tecfidera is and what it is used for
What you need to know before you take Tecfidera
How to take Tecfidera
Possible side effects
How to store Tecfidera
Contents of the pack and other information
Tecfidera is a medicine that contains the active substance dimethyl fumarate. What Tecfidera is used for
MS is a long-term condition that affects the central nervous system (CNS), including the brain and the spinal cord. Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms. Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain.
Tecfidera seems to work by stopping the body’s defence system from damaging your brain and spinal cord. This may also help to delay future worsening of your MS.
Tecfidera may affect your white blood cell counts, your kidneys and liver. Before you start Tecfidera, your doctor will do a blood test to count the number of your white blood cells and will check that your kidneys and liver are working properly. Your doctor will test these periodically during treatment. If your number of white blood cells decreases during treatment, your doctor may consider additional analytic measures or discontinue your treatment.
severe kidney disease
severe liver disease
a disease of the stomach or bowel
a serious infection (such as pneumonia)
Herpes zoster (shingles) may occur with Tecfidera treatment. In some cases, serious complications have occurred. You should inform your doctor immediately if you suspect you have any symptoms of shingles.
If you believe your MS is getting worse (e.g. weakness or visual changes) or if you notice any new symptoms, talk to your doctor straight away because these may be the symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death.
A rare but serious kidney disorder (Fanconi Syndrome) has been reported for a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease). If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
The warnings and precautions listed above also apply to children. Tecfidera can be used in children and adolescents aged 13 years and above. No data are available in children below 10 years of age.
medicines that contain fumaric acid esters (fumarates) used to treat psoriasis
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
Taking Tecfidera with certain types of vaccines (live vaccines) may cause you to get an
infection and should, therefore, be avoided. Your doctor will advise whether other types of vaccines (non-live vaccines) should be given.
Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol
can interact with this medicine. This could cause inflammation of the stomach (gastritis), especially in people already prone to gastritis.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Tecfidera if you are pregnant unless you have discussed this with your doctor. Breast-feeding
It is not known whether the active substance of Tecfidera passes into breast milk. Tecfidera should not be used during breast-feeding. 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.
The effect of Tecfidera on the ability to drive or use machines is not known. Tecfidera is not expected to affect your ability to drive and use machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Take this starting dose for the first 7 days, then take the regular dose.
Tecfidera is for oral use
If you have taken too many capsules, talk to your doctor straight away. You may experience side effects similar to those described below in section 4.
If you forget or miss a dose, do not take a double dose.
You may take the missed dose if you leave at least 4 hours between the doses. Otherwise wait until your next planned dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tecfidera may lower lymphocyte counts (a type of white blood cell). Having a low white blood cell count can increase your risk of infection, including the risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML may lead to severe disability or death. PML has occurred after 1 to 5 years of treatment and so your physician should continue to monitor your white blood cells throughout your treatment, and you should remain observant of any potential symptoms of PML as described below. The risk of PML may be higher if you have previously taken a medicine impairing the functionality of your body’s immune system.
The symptoms of PML may be similar to an MS relapse. Symptoms may include new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking, or memory; or confusion or personality changes, or speech and communication difficulties lasting for more than several days. Therefore, if you believe your MS is getting worse or if you notice any new symptoms while you are on Tecfidera treatment, it is very important that you speak to your doctor as soon as possible. Also speak with your partner or caregivers and inform them about your treatment. Symptoms might arise that you might not become aware of by yourself.
Call your doctor straight away if you experience any of these symptoms Severe Allergic reactions
The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Reddening of the face or body (flushing) is a very common side effect. However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
swelling of the face, lips, mouth or tongue (angioedema)
wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia)
dizziness or loss of consciousness (hypotension)
then this may represent a severe allergic reaction (anaphylaxis)
Stop taking Tecfidera and call a doctor straight away Very common side effects
These may affect more than 1 in 10 people:
reddening of the face or body feeling warm, hot, burning or itchy (flushing)
loose stools (diarrhoea)
feeling sick (nausea)
stomach pain or stomach cramps
Taking your medicine with food can help to reduce the side effects above
Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
These may affect up to 1 in 10 people:
inflammation of the lining of the intestines (gastroenteritis)
being sick (vomiting)
indigestion (dyspepsia)
inflammation of the lining of the stomach (gastritis)
gastrointestinal disorder
burning sensation
hot flush, feeling hot
itchy skin (pruritus)
rash
pink or red blotches on the skin (erythema)
hair loss (alopecia)
Side effects which may show up in your blood or urine tests
low levels of white blood cells (lymphopenia, leucopenia) in the blood. Reduced white blood cells could mean your body is less able to fight an infection. If you have a serious infection (such as pneumonia), talk to your doctor immediately
proteins (albumin) in urine
increase in levels of liver enzymes (ALT, AST) in the blood
These may affect up to 1 in 100 people:
Allergic reactions (hypersensitivity)
reduction in blood platelets
liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin)
herpes zoster (shingles) with symptoms such as blisters, burning, itching or pain of the skin,
typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
runny nose (rhinorrhoea)
The side effects listed above also apply to children and adolescents.
Some side effects were reported more frequently in children and adolescents than in adults, e.g, headache, stomach pain or stomach cramps, being sick (vomiting), throat pain, cough, and painful
menstrual periods.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30ºC.
Keep the blisters in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate. Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg’ and are available in packs containing 14 capsules.
Tecfidera 240 mg gastro-resistant hard capsules are green and printed with ‘BG-12 240 mg’ and are available in packs containing 56 or 168 capsules.
Not all pack sizes may be marketed. Marketing Authorisation Holder Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp The Netherlands
FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Allé 1
DK - 3400 Hillerød Denmark
Biogen Netherlands B.V. | ||
Prins Mauritslaan 13 | ||
1171 LP Badhoevedorp | ||
The Netherlands | ||
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder
Biogen Lithuania UAB Tel: +370 5 259 6176
ТП ЕВОФАРМА
Teл: +359 2 962 12 00
Biogen (Czech Republic) s.r.o. Tel: +420 255 706 200
Biogen (Denmark) A/S Tlf: +45 77 41 57 57
Pharma. MT Ltd. Tel: +356 21337008
Biogen GmbH
Tel: +49 (0) 89 99 6170
Biogen Netherlands B.V. Tel: +31 20 542 2000
Biogen Estonia OÜ Tel: +372 618 9551
Biogen Norway AS Tlf: +47 23 40 01 00
Genesis Pharma SA
Tηλ: +30 210 8771500
Biogen Austria GmbH Tel: +43 1 484 46 13
Biogen Spain, S.L. Tel: +34 91 310 7110
Biogen Poland Sp. z o.o. Tel: +48 22 351 51 00
Biogen France SAS
Tél: +33 (0)1 41 37 95 95
Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda.
Tel: +351 21 318 8450
Biogen Pharma d.o.o
Tel: +385 (0) 1 775 73 22
Johnson & Johnson Romania S.R.L. Tel: +40 21 207 18 00
Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799
Biogen Pharma d.o.o. Tel: +386 1 511 02 90
Icepharma hf
Sími: +354 540 8000
Biogen Italia s.r.l. Tel: +39 02 5849901
Biogen Finland Oy Puh/Tel: +358 207 401 200
Genesis Pharma Cyprus Ltd Tηλ: +3572 2 765740
Biogen Sweden AB Tel: +46 8 594 113 60
Biogen Latvia SIA Tel: +371 68 688 158
Biogen Idec (Ireland) Limited Tel: +44 (0) 1628 50 1000