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Precautions and Warnings With Teriflunomide

Specific Teriflunomide Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Teriflunomide has the potential to cause serious liver problems. People with liver disease may have a higher risk for this side effect. Your healthcare provider will check your liver function, using a blood test, within six months before starting you on teriflunomide, and at least monthly during the first six months of treatment. Let your healthcare provider know if you experience signs of liver problems, such as:
    • Fatigue
    • Abdominal (stomach) pain
    • Unexplained nausea and vomiting
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice).
  • Teriflunomide can decrease your white blood cell count, which would increase your risk for developing potentially serious infections. It is not recommended for use in people who already have a high risk for infections, such as those who have a weakened immune system or bone marrow disease.

    Your healthcare provider will check your white blood cell count within six months before starting you on teriflunomide. If you have a current infection, it will need to be treated before you begin teriflunomide. Let your healthcare provider know immediately if you notice any signs of an infection while taking this medication, such as:
    • Fever
    • Chills
    • Body aches
    • Cough
    • Sore throat
    • Painful urination.
  • This medication may not be safe for use in people with tuberculosis. Therefore, your healthcare provider will test you for tuberculosis (with a skin test) prior to you starting treatment.
  • You should generally not receive vaccinations that contain live viruses during teriflunomide treatment, and for at least six months after treatment ends. "Live" vaccinations include but are not limited to:
  • Teriflunomide can cause nerve damage (peripheral neuropathy). Let your healthcare provider know right away if you experience numbness, pricking, tingling, or burning sensations in the hands or feet. People who are over the age of 60, who have diabetes, or who take other medicines that can cause nerve damage may have a higher risk for getting peripheral neuropathy.
  • There have been reports of kidney failure occurring in people taking teriflunomide, which has occurred anywhere from 12 weeks to 2 years after the first dose. Let your healthcare provider know right away if you have flank pain (pain on one side of the body, between the upper stomach and the back), which could be a sign of kidney problems.
  • Some people in teriflunomide clinical trials developed high blood potassium levels (known medically as hyperkalemia). In some cases, the high potassium levels were caused by kidney failure. In other cases, the underlying cause was unknown. Let your healthcare provider know if you have signs of high blood potassium, such as:
    • Fatigue
    • An abnormal heartbeat
    • Weakness
    • Nausea and vomiting.
  • This medication may cause very serious skin reactions, including potentially life-threatening skin rashes known as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Contact your healthcare provider immediately if you notice any unexplained skin rash, redness, or peeling while taking this medication.
  • Because teriflunomide can increase blood pressure, your healthcare provider will check your blood pressure before you start treatment, and monitor it periodically throughout treatment. If your blood pressure increases too much, you may need to take blood pressure medicines.
  • Teriflunomide can cause serious, potentially life-threatening lung problems or make current lung problems worse. Let your healthcare provider know if you develop any new or worsening breathing problems during treatment, including shortness of breath or coughing.
  • It can take from eight months to two years for this drug to be completely removed from your bloodstream. Therefore, it is important to let any healthcare providers know that you have been treated with teriflunomide any time in the past two years, even if you no longer take the medication. If necessary, your healthcare provider can give you certain medicines that speed the removal of teriflunomide from the bloodstream.
  • Teriflunomide is a pregnancy Category X medication, which means it can harm a developing fetus. Women of childbearing potential must have a negative pregnancy test before starting treatment, and should use reliable birth control throughout treatment. Contact your healthcare provider right away if you are taking teriflunomide and believe you may be pregnant (see Aubagio and Pregnancy).
  • It is unknown if teriflunomide passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Aubagio and Breastfeeding).
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Teriflunomide Drug Information

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