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Teriflunomide (By mouth)

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

Treats multiple sclerosis.

Brand Name(s):

Aubagio

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

Do not use this medicine if you have had an allergic reaction to teriflunomide, or if you are pregnant. Do not use this medicine if you also use leflunomide (Arava®) or if you have severe liver disease.

How to Use This Medicine:

Tablet

  • Take your medicine as directed.
  • 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 much faster, if needed. Talk to your doctor if you have questions about this.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • 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.

How to Store and Dispose of This Medicine:

  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you also use alosetron (Lotronex®), cholestyramine (Questran®), duloxetine (Cymbalta®), paclitaxel (Taxol®), pioglitazone (Actos®), repaglinide (Prandin®), rosiglitazone (Avandia®), theophylline (Theo-Dur®), tizanidine (Zanaflex®), birth control pills (such as ethinyl estradiol, levonorgestrel, Estinyl®), or a blood thinner (such as warfarin, Coumadin®, Jantoven®).
  • Tell your doctor if you are receiving a treatment or using a medicine that causes a weak immune system, such as cancer medicines.
  • Talk to your doctor before getting flu shots or other vaccines. You should not receive live virus vaccines while you take 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. Use an effective form of birth control to prevent pregnancy.
  • Make sure your doctor knows if you are breastfeeding or if you have kidney disease, liver disease, bone marrow problems, diabetes, high blood pressure, high potassium in the blood, lung disease, nerve problems, a weak immune system, or any type of infection.
  • Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
  • 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 skin test for tuberculosis before you start to use this medicine. Tell your doctor if you develop any symptoms of infection, such as fever, chills, body aches, nausea, or vomiting.
  • Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
  • Serious skin reactions can occur. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills.
  • This medicine could make existing lung disease worse or cause new symptoms. Check with your doctor right away if you have trouble breathing and a cough.
  • You will need to have your blood pressure measured before you start using this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

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
  • Confusion, weakness, uneven heartbeat, trouble breathing
  • Dark urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
  • Decrease in how much or how often you urinate, pain in your side
  • Fast, slow, or pounding heartbeat
  • Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet
  • Unusual bleeding, bruising, or weakness

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

  • Diarrhea
  • Hair loss

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


Last Updated: 11/4/2014


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