Aubagio (teriflunomide)

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Aubagio is a once-daily pill for relapsing forms of multiple sclerosis (RMS) available by prescription. Aubagio is a type of immunomodulatory drug, called a pyrimidine synthesis inhibitor. The active ingredient in Aubagio is teriflunomide. It is made by Sanofi-Genzyme, and there are no generic forms available.1,2

How does Aubagio work?

The exact mechanism by which Aubagio works in people with MS is unknown. However, Aubagio does have recognized anti-inflammatory properties which may inhibit the immune response thought to be involved in MS. As an autoimmune disease, MS is believed to develop when the immune system becomes overactive and begins attacking the nerves in the central nervous system, causing demyelination. Aubagio inhibits a key enzyme called dihydroorotate dehydrogenase that is required by lymphocytes (a type of white blood cell involved in immune system) for normal functioning. Aubagio decreases the production of two specific types of lymphocytes, T-cells and B-cells, which play a key role in promoting CNS inflammation that causes demyelination.1,2

What are the possible side effects of Aubagio?

Like any medications, Aubagio has the possibility of causing unintended side effects. Aubagio has a black box warning, the strictest warning from the U.S. Food and Drug Administration (FDA) because of its potential to cause serious side effects, namely liver damage (hepatotoxicity) and birth defects to fetuses during pregnancy.

  • Liver damage: Severe liver damage, which may lead to fatal liver failure, has been seen in people treated with Arava® (leflunomide), a treatment for rheumatoid arthritis. A similar risk of liver damage is expected with Aubagio because both Arava and Aubagio increase the levels of teriflunomide in the blood. Because of this risk, blood tests to check for liver function are recommended before starting treatment with Aubagio (within 6 months prior to starting treatment), and at least monthly for the first six months of treatment.
  • Birth defects:  Although Aubagio has not specifically been studied in women who are pregnant, results from studies conducted in animals indicate that Aubagio may cause birth defects to a fetus. Aubagio should not be taken if you are pregnant or planning to become pregnant. If you become pregnant while taking Aubagio, you should stop taking the drug immediately and contact your doctor.1,2 Women of childbearing age should use reliable contraception while taking Aubagio and after treatment until the prescriber says it is safe to stop.

The most common side effects experienced by people taking in clinical trials were:

  • Headache
  • Diarrhea
  • Nausea
  • Alopecia (thinning of hair or hair loss)
  • Increase in alanine transaminase (ALT), an enzyme that in high levels can indicate liver damage1,3

Other rare but serious side effects that Aubagio may cause include:

  • Reduction in white blood cells, which can impact your body’s ability to fight infection
  • Numbness or tingling in the hands or feet
  • Allergic reactions (including skin problems)
  • Breathing problems
  • High blood pressure1,2

Aubagio may also cause side effects such as peripheral neuropathy and respiratory effects, including acute interstitial pneumonitis.1

Things to know about Aubagio

Before using Aubagio, talk to your doctor about all your medical conditions, particularly if you have:

  • Severe liver disease
  • Liver or kidney problems
  • Pregnancy, or plan to become pregnant
  • An allergic reaction to Aubagio or leflunomide
  • A fever or infection, or if you are unable to fight infections
  • Numbness or tingling in the hands or feet (different than your symptoms of MS)
  • Diabetes
  • Serious skin problems when taking other medications
  • Breathing problems
  • High blood pressure1,2

Prior to starting treatment with Aubagio, you will need blood tests to check your liver function, a complete blood count, a tuberculosis (TB) skin test, blood pressure check, and a pregnancy test if you are a woman of childbearing potential.2

Talk to your doctor or pharmacist about all prescription and over-the-counter medications you are taking, as well as any vitamins, nutritional supplements, and herbal products you take, as some of these may interact with Aubagio. Aubagio should not be used if you are taking leflunomide (Arava). Other drugs with known interactions with Aubagio include, but not limited to:

  • Drugs that are metabolized by the enzyme CYP2C8, such as paclitaxel, pioglitazone, repaglinide, and rosiglitazone
  • Warfarin (a common blood thinner)
  • Certain oral contraceptives
  • Drugs metabolized by the enzyme CYP1A2, such as alosetron, duloxetine, theophylline, and tizanidine
  • Drugs that are OAT3 substrates, such as cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine
  • Drugs such as rosuvastatin, mitoxantrone, methotrexate, rifampin, atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin1,4

Effects on bone marrow and potential for immunosuppression and infection. Because Aubagio may cause a decrease in white blood cells and platelets and can increase the risk of infection, a complete blood cell count should be taken before starting Aubagio (within 6 months prior to starting treatment), and further monitoring should be done during treatment if there are signs that suggest bone marrow suppression. White blood cells are produced in the bone marrow.1

There is increased risk of infection with Aubagio. If you have an infection (acute or chronic), you should not start Aubagio until the infection is resolved. If you develop a serious infection while taking Aubagio, you should consider discontinuing the drug and use an accelerated elimination procedure (as described by the manufacturer) to remove the drug from your system more quickly. Since Aubagio takes a long time to clear from the body, you may still experience the effects of the drug for a long time after discontinuing it. Aubagio is not recommended for use in people with severe immunodeficiency, bone marrow disease, or uncontrolled infections.1

Dosing information

Aubagio is available in two strengths: 7 mg or 14 mg. Both dosage strengths come in a tablet that is taken once daily, which may be taken with or without food.1