Medication Guide

Teriflunomide (ter" i floo' noe mide) tablet, for oral use

Read this Medication Guide before you start using teriflunomide tablet and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

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

Teriflunomide tablet may cause serious side effects, including:

• Liver problems: Teriflunomide tablet may cause serious liver problems, including liver failure that can be life-threatning and may require a liver transplant. Your risk of developing serious liver problems may be higher if you already have liver problems or take other medicines that also affect your liver. Your doctor should do blood tests to check your liver:
  • within 6 months before you start taking teriflunomide tablet
  • 1 time a month for 6 months after you start taking teriflunomide tablet
  Call your doctor right away if you have any of the following symptoms of liver problems:
  • nausea
  • vomiting
  • stomach pain
  • loss of appetite
  • tiredness
  • your skin or the whites of your eyes turn yellow
  • dark urine
• Harm to your unborn baby: Teriflunomide tablet may cause harm to your unborn baby. Do not take teriflunomide tablet if you are pregnant. Do not take teriflunomide tablet unless you are using effective birth control.
  • If you are a female, you should have a pregnancy test before you start taking teriflunomide tablet. Use effective birth control during your treatment with teriflunomide tablet.
  • After stopping teriflunomide tablet, continue using effective birth control until you have blood tests to make sure your blood levels of teriflunomide are low enough. If you become pregnant while taking teriflunomide tablet or within 2 years after you stop taking it, tell your doctor right away.
  • For men taking teriflunomide tablet:
    • If your female partner plans to become pregnant, you should stop taking teriflunomide tablet and ask your doctor how to quickly lower the levels of teriflunomide in your blood.
    • If your female partner does not plan to become pregnant, you and your female partner should use effective birth control during your treatment with teriflunomide tablet. Teriflunomide remains in your blood after you stop taking it, so continue using effective birth control until teriflunomide blood levels have been checked and they are low enough.

Teriflunomide may stay in your blood for up to 2 years after you stop taking it. Your doctor can prescribe a medicine to help lower your blood levels of teriflunomide more quickly. Talk to your doctor if you want more information about this.

What is teriflunomide tablet?

Teriflunomide tablet is a 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 tablet?

Do not take teriflunomide tablet 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 tablet. Please see the end of this Medication Guide for a complete list of ingredients in teriflunomide tablet.
• take a medicine called leflunomide

What should I tell my doctor before taking teriflunomide tablet?

Before you take teriflunomide tablet, tell your doctor about all of your medical conditions, including if you:

• have liver or kidney problems
• have a fever or infection, or you are unable to fight infections
• have numbness or tingling in your hands or feet that is different from your MS symptoms
• have diabetes
• have had serious skin problems when taking other medicines
• have breathing problems
• have high blood pressure
• are breastfeeding or plan to breastfeed. It is not known if teriflunomide passes into your breast milk. You and your doctor should decide if you will take teriflunomide tablet or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using teriflunomide tablet and other medicines may affect each other causing serious side effects. Teriflunomide tablet may affect the way other medicines work, and other medicines may affect how teriflunomide tablet work.

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.

How should I take teriflunomide tablet?

• Take teriflunomide tablet exactly as your doctor tells you to take it.
• Take teriflunomide tablet 1 time each day.
• Take teriflunomide tablet with or without food.

What are possible side effects of teriflunomide tablet?

Teriflunomide tablet may cause serious side effects, including:

• see " What is the most important information I should know about teriflunomide tablet? "
• decreases in your white blood cell count. Your white blood cell counts should be checked before you start taking teriflunomide tablet. When you have a low white blood cell count you:
  • may have more frequent infections. You should have a skin test for TB (tuberculosis) before you start taking teriflunomide tablet. Tell your doctor if you have any of these symptoms of an infection:
    • fever
    • tiredness
    • body aches
    • chills
    • nausea
    • vomiting
  • should not receive certain vaccinations during your treatment with teriflunomide tablet and for 6 months after your treatment with teriflunomide tablet ends.

    •allergic reactions. Stop taking teriflunomide tablet and call your doctor right away or get emergency medical help if you have difficulty breathing, itching, swelling on any part of your body including in your lips, eyes, throat, or tongue.

    •serious skin reactions. Teriflunomide tablet may cause serious skin reactions that may lead to death. Stop taking teriflunomide tablet and call your doctor right away or get emergency medical help if you have any of the following symptoms: rash or redness and peeling, mouth sores or blisters.

    •other types of allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions. Other symptoms you may have are:

  • severe muscle pain

  • swollen lymph glands

  • swelling of your face

  • unusual bruising or bleeding

  • weakness or tiredness

  • yellowing of your skin or the white part of your eyes

    If you have a fever or rash with any of the above symptoms, stop taking teriflunomide tablet and call your doctor right away

    
    
• numbness or tingling in your hands or feet that is different from your MS symptoms. You have a higher chance of getting these symptoms if you:
  • are over 60 years of age
  • take certain medicines that affect your nervous system
  • have diabetes
  Tell your doctor if you have numbness or tingling in your hands or feet that is different from your MS
• high blood pressure. Your doctor should check your blood pressure before you start taking teriflunomide tablet and while you are taking teriflunomide tablet.
• new or worsening breathing problems. These may be serious and lead to death. Call your doctor right away or get emergency medical help if you have shortness of breath or coughing with or without fever
  

The most common side effects of teriflunomide tablet include:

• headache
• diarrhea
• nausea
• hair thinning or loss (alopecia)
• increases in the results of blood tests to check your liver function

These are not all the possible side effects of teriflunomide tablet. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store teriflunomide tablet?

• Store teriflunomide tablet at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep teriflunomide tablet and all medicines out of the reach of children.

General information about the safe and effective use of teriflunomide tablet.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use teriflunomide tablet for a condition for which it was not prescribed. Do not give teriflunomide tablet to other people, even if they have the same symptoms you have. It may harm them.

You can ask your doctor or pharmacist for information about teriflunomide tablets that is written for health professionals.

What are the ingredients in teriflunomide tablet?

Active ingredient: teriflunomide

Inactive ingredients in 7 mg and 14 mg tablets: colloidal silicon dioxide, maize starch B, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating for the 14 mg and 7 mg tablet contains hypromellose, polyethylene glycol, talc and titanium dioxide.

For more information, call Biocon Pharma Inc., at 1-866-924-6266

Manufactured by:

Biocon Pharma Limited

Bengaluru,

India - 560099

Manufactured for:

Biocon Pharma Inc.,

Iselin, New Jersey, 08830-3009

United States of America

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: January 2023