Pronunciation: ter i FLOO noe mide

Brand: Aubagio

What is the most important information I should know about teriflunomide?

Do not use teriflunomide if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment.

Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Your doctor may need to test your liver function up to 6 months before you start taking teriflunomide, and then every month when you first start taking this medicine.

What is teriflunomide?

Teriflunomide affects the immune system and reduces swelling and inflammation in the nervous system.

Teriflunomide is used to reduce flare-ups in people with relapsing multiple sclerosis (MS). Teriflunomide is not a cure for MS.

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

What should I discuss with my healthcare provider before taking teriflunomide?

You should not use this medicine if you are allergic to teriflunomide or leflunomide, or if:

  • you have severe liver disease; or
  • you are also taking leflunomide (Arava).

Do not use teriflunomide if you are pregnant or may become pregnant You will need to have a negative pregnancy test before starting this treatment. Avoid getting pregnant until after you stop taking teriflunomide and undergo a "drug elimination" procedure to help rid your body of this medicine. Stop taking teriflunomide and call your doctor right away if you miss a period or think you might be pregnant.

To make sure teriflunomide is safe for you, tell your doctor if you have:

  • a history of liver disease;
  • high blood pressure;
  • a fever, or uncontrolled infections;
  • nerve problems, such as neuropathy caused by diabetes;
  • breathing problems;
  • a history of tuberculosis; or
  • any numbness or tingling that feels different from your MS symptoms.

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking teriflunomide, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

If you become pregnant while taking teriflunomide or within 2 years after you stop, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If a man fathers a child during or after teriflunomide treatment, the baby may have birth defects. Use a condom to prevent pregnancy while you are taking this medicine. After your treatment ends, continue using condoms until you have received the medications to help your body eliminate teriflunomide.

It is not known whether teriflunomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take teriflunomide?

Before you start treatment with teriflunomide, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

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

You may take teriflunomide with or without food.

Your blood pressure will need to be checked often.

Teriflunomide can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your teriflunomide treatment may be stopped for a short time based on the results of these tests.

After you stop taking teriflunomide, you may need to be treated with other medicines to help your body eliminate teriflunomide quickly. If you do not undergo this drug elimination procedure, teriflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking teriflunomide.

Store at room temperature away from moisture and heat.

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.

What should I avoid while taking teriflunomide?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using teriflunomide, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of teriflunomide?

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

Stop using teriflunomide and call your doctor at once if you have:

  • fever, chills, swollen glands, easy bruising or bleeding, muscle weakness, nausea, vomiting, tired feeling;
  • skin redness or peeling;
  • numbness, tingling, or burning pain in your hands or feet;
  • chest pain, new or worsening cough with fever, trouble breathing;
  • high blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, irregular heartbeats;
  • liver problems --upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • nausea, diarrhea;
  • thinning hair; or
  • abnormal liver function tests.

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.

What other drugs will affect teriflunomide?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cholestyramine;
  • methotrexate;
  • rifampin;
  • warfarin (Coumadin, Jantoven);
  • birth control pills or hormone replacement therapy;
  • cancer medicine;
  • medicine to treat an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
  • medicines to prevent organ transplant rejection;
  • cholesterol-lowering medication --atorvastatin, lovastatin, simvastatin, Crestor, Lipitor, Vytorin, Zocor, and others; or
  • steroid medicine --dexamethasone, prednisone, and others.

This list is not complete. Other drugs may interact with teriflunomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about teriflunomide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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