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). Teriflunomide is not a cure for MS.

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

Important information

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

You should not use this medicine if you have severe liver disease, or if you are also taking leflunomide (Arava).

Aubagio can harm an unborn baby or cause birth defects. Do not use this medicine if you are pregnant. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

Slideshow: Multiple Sclerosis: What's New in Treatment Options?

Use birth control to prevent pregnancy while you are using Aubagio, whether you are a man or a woman. Teriflunomide use by either parent may cause birth defects.

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

Your doctor may need to test your liver function up to 6 months before you start taking teriflunomide. While using Aubagio, you may need frequent blood tests at your doctor's office.

You should not use this medicine if you are allergic to teriflunomide , if you have severe liver disease, or if you are also taking leflunomide (Arava).

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

  • high blood pressure;

  • liver disease;

  • kidney disease;

  • diabetes;

  • breathing problems;

  • high levels of potassium in your blood; or

  • if you have ever had serious skin problems caused by taking medicine.

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

FDA pregnancy category X. This medication can cause birth defects. Do not use Aubagio if you are pregnant. Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you start taking Aubagio.

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

Stop taking Aubagio if you miss a period or think you might be pregnant. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends. If you get pregnant while taking teriflunomide, you will need to receive medications to help your body eliminate the drug quickly, to lower the risk of harm to your unborn baby. You may also need to go through this drug elimination procedure if you get pregnant within 2 years after you stop taking Aubagio.

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

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, or until you have received blood tests to make sure the drug has been eliminated from your body.

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?

Aubagio is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

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.

Store at room temperature away from moisture and heat.

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.

Aubagio dosing information

Usual Adult Dose for Multiple Sclerosis:

Recommended dose: 7 mg or 14 mg orally once daily.

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?

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), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Aubagio side effects

Get emergency medical help if you have any of these 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, flu symptoms, sores in your mouth and throat;

  • nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • fast or racing heartbeats;

  • numbness or tingling in your hands or feet that feels different from your regular MS symptoms;

  • pain in your side or lower back, confusion, little or no urinating;

  • chest pain, dry cough, wheezing, feeling short of breath;

  • skin redness or peeling;

  • swelling, rapid weight gain; 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:

  • diarrhea;

  • thinning hair; or

  • burning or prickly feeling in your skin.

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 medicines you use, and those you start or stop using during your treatment with Aubagio, especially:

  • acetaminophen (Tylenol);

  • alosetron;

  • duloxetine;

  • melatonin;

  • methotrexate;

  • ramelteon;

  • paclitaxel;

  • pioglitazone, rosiglitazone;

  • repaglinide;

  • tacrine;

  • theophylline;

  • tizanidine;

  • warfarin, Coumadin;

  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  • birth control pills or hormone replacement therapy;

  • cholesterol-lowering medications--Crestor, Lipitor, Pravachol, Simcor, Vytorin, Zocor, and others;

  • gout or arthritis medications (including gold injections);

  • HIV or AIDS medications;

  • medicine to treat mental illness;

  • an NSAID (non-steroidal anti-inflammatory drug)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, others;

  • seizure medication--carbamazepine, phenytoin, and others; or

  • steroids (prednisone and others).

This list is not complete. Other drugs may interact with Aubagio, 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 1996-2014 Cerner Multum, Inc. Version: 1.02. Revision Date: 2013-06-03, 2:43:35 PM.

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