Teriflunomide

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

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 nausea/vomiting that doesn't stop, dark urine, loss of appetite, stomach/abdominal pain, or yellowing eyes/skin.

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 get better or if they get worse.

Do not share this medication with others.

Lab and/or medical tests (such as tuberculosis skin test, kidney/liver function, complete blood counts, blood pressure, potassium blood levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

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. Take your next dose at the regular time. 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.

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).

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.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include ketorolac, tovorafenib, among others.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include vorasidenib, among others.

Because leflunomide (used to treat rheumatoid arthritis) is very similar to this medication, do not take it while you are taking teriflunomide.

See also Warning section.

Diarrhea, nausea, or tingling/burning/numbness/prickling feelings in your skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor 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, skin sores/ulcers, mouth/nose/genital sores.

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. Get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, swollen lymph nodes).

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. 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 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.