Teriflunomide ( Aubagio ) is an immunomodulatory drug inhibiting pyrimidine de novo synthesis by blocking the enzyme dihydroorotate dehydrogenase. Teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in multiple sclerosis.
The FDA ( Food and Drug Administration ) has approved Aubagio, a once-a-day tablet, for the treatment of adults with relapsing forms of multiple sclerosis
Important safety information
A patient should not take Aubagio if it has severe liver problems. Aubagio may cause serious liver problems, which can be life-threatening.
The risk may be higher if it takes other medicines that affect the liver.
The physician should do blood tests to check the patient’s liver within 6 months before it starts taking Aubagio and once a month for 6 months after it starts taking Aubagio.
The patient should call the doctor right away if it develops any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of skin or whites of eyes, or dark urine.
The patient should not take Aubagio if it takes a medicine called Leflunomide ( Arava ).
Aubagio can be harmful to the fetus. The patient should not take Aubagio if it is pregnant or is of childbearing age and not using effective birth control.
If a woman becomes pregnant while taking Aubagio or within 2 years after she stops taking it, she should inform the physician.
If a man is taking Aubagio whose partner plans to become pregnant, he should stop taking Aubagio and talk with doctor about reducing the levels of Aubagio in blood quickly.
If the partner does not plan to become pregnant, use effective birth control while taking Aubagio.
Aubagio may stay in the blood for up to 2 years after the patient stops taking it. The physician can prescribe a medicine that can help remove Aubagio from body quickly.
Before taking Aubagio, the patient should talk with physician if it has: liver or kidney problems; a fever or infection, or if it is unable to fight infections; numbness or tingling in hands or feet that is different from multiple sclerosis symptoms; diabetes; serious skin problems when taking other medicines; breathing problems; high blood pressure.
It is not known if Aubagio passes into breast milk. The patient should talk with doctor to decide if it should take Aubagio or should breastfeed.
Also talk with doctor if it takes or is planning to take other medicines ( especially medicines for treating cancer or controlling immune system ) or if it takes or is planning to take vitamins or herbal supplements.
Before starting Aubagio, the physician should check white blood cell count and perform a tuberculosis skin test.
The patient should not receive certain vaccinations during and for 6 months after treatment with Aubagio.
Aubagio may cause serious side effects, including: reduced white blood cell count ( risk of a higher incidence of infections ); numbness or tingling in hands or feet that is different from multiple sclerosis symptoms; kidney problems; high potassium levels in blood; serious skin problems; breathing problems ( new or worsening ); high blood pressure.
The most common side effects of Aubagio include: abnormal liver test results; hair thinning or loss; diarrhea; flu; upset stomach; burning or prickling feeling in skin.
Source: Genzyme, 2013
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