Teriflunomide must not be used during pregnancy because it may cause serious harm (such as birth defects, death) in an unborn baby. Women of childbearing age must have a negative pregnancy test before starting this medication. Men and women must use reliable forms of birth control (such as condoms, birth control pills) while taking teriflunomide and for as long as directed by your doctor to prevent pregnancy. After stopping treatment with teriflunomide, your doctor may prescribe a different drug to help speed up the removal of teriflunomide from your body. If you become pregnant or think you may be pregnant or cause a pregnancy, tell your doctor right away. (See also How to Use and Precautions sections.)
This drug may rarely cause serious (possibly fatal) liver disease. Careful monitoring by your doctor may help decrease your risk. Your doctor will perform liver function tests before you start treatment and once a month for at least the first 6 months of treatment. Tell your doctor right away if you notice dark urine, loss of appetite, persistent nausea/vomiting, stomach/abdominal pain, or yellowing eyes/skin.Who should not take teriflunomide?
This medication is used to treat relapsing forms of multiple sclerosis-MS. It is not a cure for MS but is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in your brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS.
Read the Medication Guide provided by your pharmacist before you start taking teriflunomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
After treatment is stopped, your doctor may prescribe a different drug (cholestyramine or activated charcoal powder) to help speed up the removal of teriflunomide from your body. This may be used if you have severe side effects, or if you are a woman of childbearing age, or a man planning to father a child. Otherwise, teriflunomide can stay in your body for as long as 2 years after stopping treatment. Consult your doctor or pharmacist for more details.
Tell your doctor if your symptoms do not improve or if they worsen.
Diarrhea, nausea, or tingling/burning/numbness/prickling feelings in your skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, new/worsening shortness of breath, new/worsening numbness/tingling of hands/feet, pain in your side (flank pain), symptoms of high potassium blood levels (such as muscle weakness, slow/irregular heartbeat), unusual tiredness.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).
Teriflunomide can cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking teriflunomide, tell your doctor or pharmacist if you are allergic to it; or to leflunomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone marrow/blood disorder, immune system disorder (such as due to cancer, HIV infection), current/recent infection (such as tuberculosis), high blood pressure, liver problems, lung disease.
Teriflunomide can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Teriflunomide may pass into the semen of men treated with this medication and the effects on sperm are unknown. Men not wishing to father a child with their female partners should use reliable birth control (such as condoms). After stopping this medication, men wishing to father a child should take a different drug as prescribed by the doctor to speed up removal of teriflunomide from the body. (See also How to Use section.)
This medication must not be used during pregnancy. It may harm an unborn baby. Before starting this medication, women of childbearing age must have a negative pregnancy test. Discuss the use of reliable forms of birth control (such as birth control pills, intrauterine device-IUD) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately. See also Warning section.
This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Because leflunomide (used to treat rheumatoid arthritis) is very similar to this medication, do not take it while you are taking teriflunomide.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as tuberculosis skin test, kidney/liver function, complete blood counts, blood pressure, potassium blood levels) should be performed before you start treatment, and periodically to monitor your progress or check for side effects. If you are prescribed a different drug to help speed up the removal of teriflunomide after stopping treatment, your doctor may also check your blood levels of teriflunomide (see also How to Use section). Keep all regular medical and laboratory appointments.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2015. Copyright(c) 2015 First Databank, Inc.
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