tecfidera

Tecfidera (dimethyl fumarate) is a prescription medicine used to treat relapsing multiple sclerosis.

Tecfidera may also be used for purposes not listed in this medication guide.

Important information

Before taking and while you take Tecfidera, tell your doctor if you have or have had a low white blood cell counts or an infection.

Tecfidera may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Before taking this medicine

You should not use Tecfidera if you are allergic to dimethyl fumarate.

To make sure Tecfidera is safe for you, tell your doctor if you have an active infection.

Your doctor may perform blood tests to make sure you do not have conditions that would prevent you from safely using this medicine.

FDA pregnancy category C. It is not known whether Tecfidera will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Tecfidera on the baby.

It is not known whether dimethyl fumarate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Tecfidera?

Take Tecfidera exactly as your doctor has prescribed Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Tecfidera with or without food.

Do not crush, chew, break, or open a capsule. Swallow it whole.

Tecfidera is usually given in two different strengths, one for a starter dose and the other for a maintenance dose. The starter dose is usually taken for only 7 days. Follow your doctor"s dosing instructions very carefully.

Store at room temperature away from moisture, heat, and light. Throw away any unused capsules 90 days after you first opened the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Tecfidera dosing information

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 120 mg orally twice a day for 7 days.
Maintenance dose: 240 mg orally twice a day.

Approved indication: The treatment of patients with relapsing forms of multiple sclerosis.

What other drugs will affect Tecfidera?

Other drugs may interact with Tecfidera , including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What should I avoid?

Follow your doctor"s instructions about any restrictions on food, beverages, or activity.

Tecfidera side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tecfidera: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tecfidera may cause a serious viral infection of the brain that can lead to disability or death. Symptoms may start gradually and get worse quickly.Call your doctor right away if you have:

• any change in your mental state;

• decreased vision;

• weakness on one side of your body;

• problems with speech or walking.

• fever, pain when swallowing, cold or flu symptoms;

• severe stomach pain; or

• severe feeling of warmth or tingling, or a burning sensation.

Common Tecfidera side effects may include:

• nausea, diarrhea, stomach pain; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Tecfidera?

Other drugs may interact with Tecfidera , including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.