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What is Aubagio?

 

Aubagio (teriflunomide) is a prescription medicine used as a disease-modifying therapy (DMT) for multiple sclerosis (MS) in relapsing forms. This includes relapsing-remitting disease, active secondary progressive disease, and clinically isolated syndrome in patients as young as 10 years with multiple sclerosis. Aubagio is manufactured by Sanofi.

How does Aubagio work?

Multiple sclerosis causes the body’s immune system to attack its own central nervous system (the brain and spinal cord), resulting in nerve damage. Aubagio, whose active ingredient is teriflunomide, is a pyrimidine synthesis inhibitor. It reduces the number of lymphocytes, a type of white blood cell found in bone marrow involved in the inflammation process of the central nervous system. By slowing down the inflammation process, Aubagio reduces the number of relapses related to forms of multiple sclerosis.

What doses of Aubagio are available?

Aubagio is available in a 7mg or 14mg tablet and is typically taken orally once daily. For children prescribed Aubagio, the dose and usage may vary at the recommendation of a healthcare provider.

How do you use Aubagio?

Before using Aubagio, ensure you follow all directions given to you by your healthcare provider. Read all directions on your prescription label, and follow all instructions for use on your medication guide. Your healthcare provider may test for other infections, such as tuberculosis, before allowing you to start Aubagio treatment.

Aubagio can be taken orally with or without food. You will require frequent blood tests as teriflunomide can lower blood cell counts. Your blood pressure will also need to be checked regularly.

After treatment with Aubagio is stopped, your doctor may prescribe medications such as cholestyramine or activated charcoal to help speed up the removal of teriflunomide from your body.

If you can become pregnant, a pregnancy test should be conducted before starting this medication. Be sure to consult your healthcare provider if you are trying to become pregnant as Aubagio may cause harm to your unborn baby.

What are the side effects of Aubagio?

The most common side effects of Aubagio in clinical trials compared to placebo include:

  • Headache

  • Body aches or pain

  • Nausea or diarrhea

  • Thinning hair or hair loss

  • Abnormal liver function

  • Joint pain

  • High blood pressure 

Rarely, Aubagio may cause some serious side effects, including:

  • Serious skin reactions, including:

    • Blistering

    • Peeling

    • Skin lesions

  •  Abnormal or worsening liver problems, including:

    • Liver disease

    • Tiredness

    • Loss of appetite

    • Yellowing of the eyes or skin

    • Dark urine

    • Increased liver enzymes

  • Decrease in white blood cell count, including:

    • Neutrophils

    • Lymphocytes

    • Platelets

  • Respiratory problems, such as interstitial lung disease

  • Severe allergic reactions, including:

    • Trouble breathing

    • Swelling or itching of eyes, lips, throat

    • Vomiting

  • Itching or numbness of the skin that differs from common MS symptoms or relapsing MS symptoms

  • Symptoms of peripheral neuropathy, including:

    • Loss of balance

    • Weakness in the feet

    • Numbness in the hands or feet

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Aubagio. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Aubagio drug interactions

When Aubagio is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Aubagio include:

  • Atorvastatin

  • Ibuprofen

  • Aspirin

  • Omeprazole

  • Duloxetine

  • Prednisone

  • Warfarin  

Boxed warnings

Serious and potentially life-threatening liver injury and liver failure that could require a transplant, have been reported in patients treated with Aubagio once it came onto the market. Using it with other medications that can cause liver injury increases this risk. Certain liver enzyme and liver function tests should be performed within 6 months before starting Aubagio and at least monthly for 6 months. If liver injury from Aubagio is suspected, stop treatment and begin an accelerated elimination procedure with cholestyramine or activated charcoal.

Birth defects and fetal death occurred in animals given Aubagio. Because of this, a pregnancy test should be given to rule out pregnancy before beginning treatment with Aubagio. Females should also use effective contraception while on Aubagio if they can become pregnant. If the patient becomes pregnant while on Aubagio, it should be stopped, and an accelerated elimination procedure should be started.

See full prescribing information for complete box warnings.

Aubagio precautions

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

  • Existing liver problems or symptoms of life-threatening liver problems

  • Are pregnant, or trying to become pregnant (teriflunomide may cause birth defects)

  • Are breastfeeding or plan to breastfeed (it is unknown if Aubagio may pass into breast milk)

  • Are of childbearing potential and are not taking effective birth control or contraception

  • A partner who plans to become pregnant

  • Existing high blood pressure

  • Allergies to teriflunomide or leflunomide

  • Are taking leflunomide for rheumatoid arthritis

  • Are planning to take any form of vaccine while on Aubagio

Is there a generic available for Aubagio?

Yes, teriflunomide (oral tablet) is the generic for Aubagio and is available in the US. 

How do you store Aubagio?

You should store Aubagio in its original container at room temperature.

Aubagio should be stored in its original container at room temperature between 59°F to 77°F (15°C to 25°C) away from light and moisture. Do not freeze the medication. Keep away from pets and children.

Do not continue using Aubagio once instructed by your healthcare provider or once the medication is out of date. Ensure to dispose of the medication safely.

Related medications

 

Sources

Drugs.com https://www.drugs.com/aubagio.html#warnings

Manufacturer https://www.aubagio.com/

RX List https://www.rxlist.com/aubagio-drug.htm

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