Generic Name: teriflunomide (ter i FLOO noe mide)
Brand Names: Aubagio

What is Aubagio?

Aubagio (teriflunomide) affects the immune system and reduces swelling and inflammation in the nervous system.

Aubagio is used to reduce flare-ups in people with relapsing multiple sclerosis (MS).

Aubagio is not a cure for MS.

Important information

Do not use Aubagio if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

Aubagio 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.

Slideshow: Flashback: FDA Drug Approvals 2013

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 Aubagio, and then every month when you first start taking this medicine.

Aubagio can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. While using Aubagio, you may need blood tests every 6 months. Your blood pressure will also need to be checked often.

After you stop taking Aubagio, the drug could stay in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate teriflunomide quickly. Follow your doctor's instructions.

Before taking this medicine

You should not use Aubagio if you are allergic to teriflunomide, or if:

  • you have severe liver disease; or

  • you are also taking leflunonmide (Arava).

Do not use Aubagio 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 this medicine and undergo a "drug elimination" procedure to help rid your body of this medicine. Stop taking Aubagio and call your doctor right away if you miss a period or think you might be pregnant.

To make sure Aubagio 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 Aubagio, 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 Aubagio 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 Aubagio 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 Aubagio?

Before you start treatment with Aubagio, 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 Aubagio with or without food.

Your blood pressure will need to be checked often.

Aubagio 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 treatment may be stopped for a short time based on the results of these tests.

After you stop taking Aubagio, 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 this medicine.

Store at room temperature away from moisture and heat.

Aubagio dosing information

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once a day

Use: Treatment of patients with relapsing forms of multiple sclerosis.

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 Aubagio?

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 Aubagio, 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.

Aubagio side effects

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

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

  • fever, chills, body aches, nausea, vomiting, tired feeling;

  • skin redness or peeling;

  • numbness, tingling, or burning pain in your hands or feet;

  • 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 Aubagio 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.

See also: Side effects (in more detail)

What other drugs will affect Aubagio?

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 Aubagio.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Aubagio only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 2.01. Revision Date: 2015-02-11, 7:46:46 AM.

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