Aubagio

The active ingredient in Aubagio is teriflunomide. 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 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.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Aubagio. However, the following is a synopsis of the general guidelines for the use of Aubagio:

• 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

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

• Headache
• Nausea
• Diarrhea
• Thinning hair or hair loss
• Abnormal liver function tests
• Joint pain
• High blood pressure

Some individuals may experience serious side effects while using Aubagio. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious skin reactions, including:
• Blistering
• Peeling
• Skin lesions
• Abnormal or worsening liver problems, including:
• 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
• Allergic reaction with symptoms such as:
• Hives
• Swelling of the face, tongue, or throat
• Trouble breathing
• Peripheral neuropathy
• Numbness or tingling in your hands or feet

These are not all of the possible side effects of Aubagio. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Aubagio, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you:

• Have liver disease
• Are pregnant, or trying to become pregnant
• Are breastfeeding or plan to breastfeed
• Are childbearing potential and are not taking effective birth control or contraception
• 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

Boxed Warning

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 (teriflunomide) is contraindicated in the following situations:

• Severe liver impairment.
• Pregnancy or women of childbearing potential not using effective contraception.
• Current treatment with leflunomide.
• Hypersensitivity to teriflunomide or any component of the medication.
• Severe immunodeficiency, bone marrow disease, or uncontrolled infections.

Aubagio (teriflunomide) may take 1 to 2 months to start showing effects, with noticeable improvements in reducing relapses or slowing disease progression often seen after 3 to 6 months of treatment. Full benefits may take longer to assess. Always follow your doctor's guidance and schedule regular check-ups.

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. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Atorvastatin
• Ibuprofen
• Aspirin
• Omeprazole
• Duloxetine
• Prednisone
• Warfarin

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.

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.

Aubagio is manufactured by Sanofi.

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

To stop taking Aubagio, consult your doctor. They may recommend a specific procedure to discontinue the medication, often involving the use of cholestyramine or activated charcoal to help speed up the removal of the drug from your system, especially if stopping early. Never stop Aubagio abruptly without medical advice.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Aubagio may cause serious harm to your unborn baby and should be avoided. If you or your partner can have children, you need to use birth control while taking this medication.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. It is not recommended to breastfeed while taking Aubagio because it may pass into your breast milk and potentially cause severe side effects in your baby.