What is the most important information I should know about teriflunomide tablets?

Teriflunomide tablets can cause serious side effects, including:

1. Liver Problems

Teriflunomide may lead to severe liver issues, including liver failure, which can be life-threatening and may require a liver transplant. Your risk is higher if you already have liver conditions or are taking other medications that affect the liver.

Your doctor should check your liver function with blood tests:

• Within 6 months before starting teriflunomide

• Once a month for 6 months after starting treatment

Call your doctor immediately if you notice any signs of liver problems, such as:

• Nausea

• Vomiting

• Stomach pain

• Loss of appetite

• Fatigue or unusual tiredness

• Yellowing of your skin or the whites of your eyes

• Dark urine

2. Risk to Unborn Babies

Teriflunomide can harm an unborn baby. Do not take teriflunomide if you are pregnant or planning to become pregnant, unless you are using effective birth control.

• Females:

  • You must take a pregnancy test before starting treatment.

  • Use effective birth control during treatment.

  • After stopping teriflunomide, continue using birth control until blood tests confirm the drug level is low enough.

If you become pregnant while taking teriflunomide or within 2 years of stopping it, contact your doctor immediately.

• Males:

  • If your female partner plans to become pregnant, stop taking teriflunomide and consult your doctor about how to quickly reduce the drug level in your blood.

  • If your partner is not planning pregnancy, both of you should use effective birth control during treatment and until your blood levels of teriflunomide are confirmed to be low enough.

Teriflunomide can remain in your blood for up to 2 years after stopping treatment. Your doctor can prescribe a medication to help remove it from your body more quickly. Talk to your doctor if you’d like more information.

What are teriflunomide tablets?

• Teriflunomide tablets are prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• It is not known if teriflunomide   tablets are safe and effective in children.

Who should not take teriflunomide tablets?
Do not take teriflunomide tablets if you:

• have severe liver problems.
• are pregnant or are of childbearing age and not using effective birth control.
• have had an allergic reaction to leflunomide, teriflunomide, or any other ingredients in teriflunomide tablets. Please see the end of this Medication Guide for a complete list of ingredients in teriflunomide tablets.
• take a medicine called leflunomide.

What should I tell my doctor before taking teriflunomide tablets?

Before starting teriflunomide tablets, let your doctor know about all of your medical conditions, especially if you:

• Have liver or kidney problems

• Have a fever, an ongoing infection, or a weakened immune system

• Experience numbness or tingling in your hands or feet that differs from your usual MS symptoms

• Have diabetes

• Have had serious skin reactions to other medications

• Have any breathing issues

• Have high blood pressure

• Are breastfeeding or planning to breastfeed

  • It is unknown if teriflunomide passes into breast milk. You and your doctor should decide whether you will take teriflunomide or breastfeed—you should not do both.

Also, be sure to tell your doctor about all medications you are currently taking, including:

• Prescription drugs

• Over-the-counter medications

• Vitamins and herbal supplements

Teriflunomide may interact with other medications, potentially causing serious side effects. It can also affect how other drugs work, and vice versa.

Especially tell your doctor if you take medicines that could raise your chance of getting infections, including medicines used to treat cancer or to control your immune system.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.