(ter'' i floo' noe mide)
Teriflunomide may cause serious or life-threatening liver damage. The risk of liver damage may be increased in people taking other medications known to cause liver damage, and in people who already have liver disease. Tell your doctor if you have liver disease. Your doctor may tell you not to take teriflunomide. Tell your doctor and pharmacist about all the medications you are taking so they can check whether any of your medications may increase the risk that you will develop liver damage during your treatment with teriflunomide. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, extreme tiredness, unusual bleeding or bruising, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark-colored urine, or flu-like symptoms. If liver damage is suspected, your doctor may stop teriflunomide treatment and may give you a treatment that will help to remove teriflunomide more quickly from your body.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before you begin your treatment and regularly during your treatment to check your body's response to teriflunomide.
Do not take teriflunomide if you are pregnant or plan to become pregnant. Teriflunomide may harm the fetus. You should not begin taking teriflunomide until you have taken a pregnancy test with negative results and your doctor tells you that you are not pregnant. You must use an effective method of birth control before you begin taking teriflunomide, during your treatment with teriflunomide, and for up to 2 years after treatment, until blood tests show that you have low enough levels of teriflunomide in your blood. If your period is late, you miss a period, or you think you may be pregnant during your treatment with teriflunomide or for 2 years after your treatment, call your doctor immediately. If you plan to become pregnant or can become pregnant, talk to your doctor about a treatment that will help to remove teriflunomide more quickly from your body after you stop taking the medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with teriflunomide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking teriflunomide.
WHY is this medicine prescribed?
Teriflunomide is used to prevent episodes of symptoms and slow the worsening of disability in patients with relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Teriflunomide is in a class of medications called immunomodulatory agents. It is thought to work by decreasing inflammation and decreasing the action of immune cells that may cause nerve damage.
HOW should this medicine be used?
Teriflunomide comes as a tablet to take by mouth. It is usually taken once a day, with or without food. Take teriflunomide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take teriflunomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Teriflunomide may help control the symptoms of multiple sclerosis but does not cure it. Continue to take teriflunomide even if you feel well. Do not stop taking teriflunomide without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking teriflunomide,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Teriflunomide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
Teriflunomide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.