Tecfidera - Dimethyl fumarate uses, dose and side effects

MS is a long-term disease that affects the central nervous system ( CNS ), including the brain and spinal cord. Relapsing-remitting MS is characterized by repeated attacks ( relapses ) of symptoms from the nervous system. Symptoms vary between patients but usually include walking problems, a feeling of poor balance, and vision problems (eg, blurred vision or double vision). These symptoms may disappear completely when the relapse is over, but some problems may remain.

How Tecfidera works

It appears that Tecfidera works by preventing the body’s immune system from damaging the brain and spinal cord. This may also help delay the future worsening of your MS.

What you need to know before you take Tecfidera

Do not take Tecfidera

if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6).
if you are suspected of suffering from a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if you have confirmed PML.

Warnings and precautions

Tecfidera can affect the number of white blood cells, the kidneys, and the liver. Before you start taking Tecfidera, your doctor will test your blood to count the number of white blood cells and check that your kidneys and liver are working properly. The doctor tests this regularly during the treatment. If your white blood cell count drops during treatment, your doctor may consider taking additional tests or stopping your treatment.

Talk to your doctor before taking Tecfidera if you have:

a severe kidney disease
a severe liver disease
a disease of the stomach or intestine
a serious infection (eg pneumonia )

Herpes zoster ( shingles ) can occur during treatment with Tecfidera. In some cases, serious complications have occurred. You should inform the doctor immediately if you suspect that you have symptoms of shingles.

Talk to your doctor straight away if you think your MS is getting worse (eg weakness or vision changes) or if you notice new symptoms. These may be symptoms of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or be life-threatening.

A rare but serious kidney disease (Fanconi syndrome) has been reported for a medicine containing dimethyl fumarate in combination with other fumaric acid esters and used to treat psoriasis (a skin disease). If you notice that you urinate more, are thirstier, and drink more than usual, if your muscles seem weak, if 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.

Children and young people

The warnings and precautions listed above also apply to children. Tecfidera can be used in children and adolescents from the age of 13.

Other medicines and Tecfidera

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular:

medicines containing fumaric acid esters (fumarates) used to treat psoriasis
medicines that affect the body’s immune system including other medicines used to treat MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some common cancer treatments (rituximab or mitoxantrone)
medicines that affect the kidneys including certain antibiotics (used to treat infections ), ” water tablets ” ( diuretics ), certain types of painkillers (such as ibuprofen and other similar anti-inflammatory and over-the-counter medicines), and medicines containing lithium
If you take Tecfidera with certain types of vaccines ( live vaccines ), you may get an infection and you should therefore avoid such vaccines. The doctor will decide whether other types of vaccines ( non-live vaccines ) should be given.

Tecfidera with alcohol

Consumption of more than a small amount (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, eg spirits) should be avoided within one hour before and after taking Tecfidera, as alcohol can affect this drug. It can cause inflammation of the stomach ( gastritis ), especially in people who are already prone to gastritis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use Tecfidera if you are pregnant unless you have first discussed it with your doctor.

Breast-feeding

It is unknown whether the active substance in Tecfidera is excreted in breast milk. Tecfidera should not be used during breastfeeding. Your doctor will help you decide whether to stop breastfeeding or to stop using Tecfidera. This means that the benefit of breastfeeding for the baby is compared to the benefit of treatment for you.

Driving ability and use of machinery

The effect of Tecfidera on the ability to drive and use machines is not known. Tecfidera is not expected to affect the ability to drive or use machines.

How to take Tecfidera

Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.

Starting dose

120 mg twice daily.

Take the starting dose for the first 7 days and then take the regular dose.

Usual dose

240 mg twice daily.

Tecfidera should be swallowed.

Swallow the capsules whole with a little water. You must not split, crush, dissolve, suck on or chew the capsule as this may increase certain side effects.

Take Tecfidera with food – it may help to reduce some of the very common side effects (listed in section 4).

If you have taken too much Tecfidera

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 to take Tecfidera

Do not take a double dose to make up for a forgotten or missed dose.

You can take the missed dose if you leave at least 4 hours between doses. Otherwise, you wait until it is time for your next scheduled dose.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious effects

Tecfidera can lower the number of lymphocytes (a type of white blood cell ). Having a low white blood cell count can increase your risk of infection, including the risk of getting an unusual brain infection called progressive multifocal leukoencephalopathy (PML). PML can lead to severe disability or be life-threatening. PML has occurred after 1 to 5 years of treatment and the doctor should therefore continue to check the count via blood cells throughout treatment and you should be alert for any symptoms of PML described below. The risk of PML may be higher if you have previously taken medication that inhibits the function of the body’s immune system.

The symptoms of PML can 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; confusion or personality changes, or speech and communication difficulties that last longer than a few days. It is therefore very important that you talk to your doctor as soon as possible if you think your MS is getting worse or if you notice any new symptoms while you are being treated with Tecfidera. Also, talk to your partner or caregiver and inform them about your treatment. Symptoms may occur that you may not be aware of yourself.

Contact your doctor immediately if you experience any of these symptoms

Severe allergic reactions

The frequency of severe allergic reactions cannot be estimated from the available data (no frequency known).

Redness of the face or body ( flush ) is a very common side effect. If, however, you develop redness on your face or body along with a red rash or hives and experience any of these symptoms:

swelling of the face, lips, mouth, or tongue ( angioedema )
wheezing, difficulty breathing, or shortness of breath ( dyspnea, hypoxia )
dizziness or fainting ( hypotension )

could it be a severe allergic reaction ( anaphylactic reaction )

Stop taking Tecfidera and see a doctor immediately

Very common side effects are

These may affect more than 1 in 10 people:

redness of the face or body, feeling of heat, hotness, burning or itching ( flush )
loose stools ( diarrhea )
nausea
stomach pain or stomach cramps
If you take the medicine in conjunction with food, it can help to reduce the above-mentioned side effects

While taking Tecfidera, substances called ketones, which are produced naturally in the body can very often be seen in urine tests.

Talk to your doctor about how to manage these side effects. The doctor may lower the dose. Do not lower the dose unless your doctor tells you to.

Common side effects are

These may affect up to 1 in 10 people:

inflammation of the intestines ( gastroenteritis )
vomiting
indigestion ( dyspepsia )
inflammation of the stomach ( gastritis )
gastrointestinal upset
burning sensation
hot flush, feeling of warmth
itching of the skin ( pruritus )
rash
pink or red spots on the skin ( erythema )
hair loss ( alopecia )

Side effects that can show up in blood or urine tests

a low number of white blood cells ( lymphopenia, leukopenia ) in the blood. A reduced number of white blood cells can mean that the body has less ability to fight infection. If you get a serious infection (e.g. pneumonia ), you must talk to your doctor straight away
protein ( albumin ) in the urine
elevation of liver enzymes ( ALT, AST ) in the blood

Uncommon side effects These
may affect up to 1 in 100 people:

allergic reactions ( hypersensitivity )
decreased number of platelets

Frequency not known (cannot be estimated from available data)

liver inflammation and increased levels of liver enzymes ( A LAT or AST in combination with bilirubin )
herpes zoster ( shingles ) with symptoms such as blisters, burning sensation, itching, or pain in the skin, typically on one side of the upper body or in the face, and other symptoms such as fever and weakness during the early stages of infection a followed by numbness, itching or red spots with severe pain
runny nose ( rhinorrhea )

Children (13 years and older) and young people

The side effects listed above also apply to children and young people.

Some side effects were reported more often in children and adolescents than in adults, eg headache, stomach pain or stomach cramps, nausea (vomiting), sore throat, cough, and painful periods.

How to store Tecfidera

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the blister pack and carton after EXP The expiry date is the last day of the month indicated.

Store at a maximum of 30 °C. Store the blister pack in the outer carton. Light sensitive.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substance is dimethyl fumarate.

Tecfidera 120 mg: One capsule contains 120 mg of dimethyl fumarate.

Tecfidera 240 mg: One capsule contains 240 mg of dimethyl fumarate.

Other ingredients are microcrystalline cellulose, croscarmellose sodium, talc, silicon dioxide ( colloidal, anhydrous), magnesium stearate, triethyl citrate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, simethicone, sodium lauryl sulfate, polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide and black iron oxide (E172).

Appearance and package sizes of the medicine

Tecfidera 120 mg gastro-resistant capsules, hard, are green and white and marked “BG-12 120 mg” and are available in packs of 14 capsules.

Tecfidera 240 mg gastro-resistant capsules, hard, are green and marked “BG-12 240 mg” and are available in packs of 56 or 168 capsules.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Biogen Netherlands BV

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

Manufacturer

FUJIFILM Diosynth Biotechnologies Denmark ApS

Biotek Allé 1

DK – 3400 Hillerød

Denmark