Tecfidera

This leaflet answers some common questions about TECFIDERA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet.

You can also download the most up to date leaflet from: www.biogen.com.au/products/tecfidera-CMI.pdf

All medicines have risks and benefits. Your doctor has weighed the risks of you taking TECFIDERA against the benefits they expect it will have for you.

You may need to read it again.

TECFIDERA is used to treat relapsing multiple sclerosis (MS).

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 (e.g. 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.

Your doctor may have prescribed it for another reason.

TECFIDERA has not been studied in patients with chronic progressive MS.

Safety and effectiveness in children younger than 18 years have not been established.

This medicine is not addictive.

This medicine is available only with a doctor's prescription.

Some of the symptoms of an allergic reaction may include:

If it has expired or is damaged, return it to your pharmacist for disposal.

There is no information on the use of TECFIDERA during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.

It is not known whether TECFIDERA passes into breast milk. Your doctor will discuss the risks and benefits of taking it if you are breast-feeding.

You should not take TECFIDERA together with these medicines.

Some medicines and TECFIDERA may interfere with each other. These include:

These medicines may be affected by TECFIDERA or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

They may differ from the information contained in this leaflet.

The recommended starting dose of TECFIDERA is 120 mg taken twice daily. After 7 days the recommended dose is 240 mg twice daily.

Taking it at the same time each day (e.g. at morning during breakfast and at night during dinner) will help you remember 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.

Your doctor may tell you to take TECFIDERA with aspirin or may temporarily reduce your dose.

This medicine helps to control your condition, but does not cure it. The positive effects of TECFIDERA may not be seen immediately. It is important to keep taking your medicine even if you feel well.

It is important not to interrupt treatment with TECFIDERA unless your doctor tells you to.

This may increase the chance of you getting an unwanted side effect.

You may need urgent medical attention.

Blood and urine test results may be affected by treatment with TECFIDERA.

Before you start TECFIDERA, your doctor will do a blood test to check the number of your white blood cells. Your doctor may also test these periodically during treatment.

Before you start TECFIDERA, your doctor will make sure you have results from a recent urine test to check your kidney function and may repeat the test periodically during treatment. TECFIDERA may cause proteins (such as albumin) to be detected in a urine test.

TECFIDERA may also cause increases in the level of liver enzymes that will show up in a blood test.

TECFIDERA may decrease lymphocyte (white blood cell) counts. White blood cells fight infection. You may get infections more easily while you are taking TECFIDERA. Any infection that you already have may get worse. Infections could be serious and sometimes life-threatening. If you have a serious infection, your doctor may recommend that you stop taking TECFIDERA until you recover.

These could be signs of a rare and very serious brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to an MS relapse.

Having a low white blood cell count for a long period of time may increase your risk of PML.

Before you start TECFIDERA, your doctor will do a blood test to check the number of your white blood cells. Your doctor may also test these periodically during treatment.

Before you start TECFIDERA, your doctor will make sure you have results from a recent urine test to check your kidney function and may repeat the test periodically during treatment. TECFIDERA may cause proteins (such as albumin) to be detected in a urine test.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

The above list includes the more common side effects of your medicine. If any of these persist or worsen, talk to your doctor as some of them may also be due to an infection or allergic reaction.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

If you take the capsules out of the pack they may not keep well.

Heat and dampness can destroy some medicines.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

TECFIDERA 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 14 or 56 capsules packed in a box.

Not all pack sizes may be available.

TECFIDERA contains dimethyl fumarate as the active ingredient.

Other ingredients: