Teriflunomide (ter-i-FLOO-noe-mide)

Treats multiple sclerosis.

Brand Name(s):

Aubagio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with leflunomide.
• Some medicines can affect how teriflunomide works. Tell your doctor if you are using any of the following:
  • Alosetron, cefaclor, cholestyramine, cimetidine, ciprofloxacin, duloxetine, furosemide, ketoprofen, methotrexate, mitoxantrone, nateglinide, paclitaxel, penicillin G, pioglitazone, repaglinide, rifampin, rosiglitazone, theophylline, tizanidine, or zidovudine
  • Birth control pills
  • Blood thinner (including warfarin)
  • Medicines that can weaken your immune system, including steroids or cancer medicines
  • Statin medicines (including atorvastatin, pravastatin, simvastatin)
• Talk to your doctor before you get flu shots or other vaccines. You should not receive live virus vaccines during treatment and for at least 6 months after you stop using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy.
• Teriflunomide may stay in your blood for up to 2 years after you stop using it. Your doctor can give you medicine to remove it from your body faster, if needed. Talk to your doctor if you have questions or concerns about this.
• Do not breastfeed during treatment with this medicine
• Tell your doctor if you have kidney disease, liver disease, bone marrow problems, diabetes, high blood pressure, lung disease, nerve problems, any type of infection, or a history of tuberculosis.
• This medicine may cause the following problems:
  • Liver problems
  • Lung problems
  • Increased risk of cancer
  • Peripheral neuropathy
  • Serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which may affect multiple organs, including liver, kidneys, or heart
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• You will need to have a test for tuberculosis before you start to use this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will also need to check your blood pressure.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Cough, trouble breathing or swallowing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Fever, chills, runny or stuffy nose, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Swollen, painful, or tender lymph glands in your neck, armpit, or groin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Hair loss
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088