Medication Guide

Teriflunomide (ter'' i floo' noe mide) Tablets

Read this Medication Guide before you start using teriflunomide tablets 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 tablets?

Teriflunomide tablets may cause serious side effects, including:

• Liver problems: Teriflunomide tablets may cause serious liver problems that may lead to death. Your risk of liver problems may be higher if you 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 tablets
  • 1 time a month for 6 months after you start taking teriflunomide tablets

  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 tablets may cause harm to your unborn baby. Do not take teriflunomide tablets if you are pregnant. Do not take teriflunomide tablets unless you are using effective birth control.
  • If you are a female, you should have a pregnancy test before you start taking teriflunomide tablets. Use effective birth control during your treatment with teriflunomide tablets.
  • After stopping teriflunomide tablets, 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 tablets or within 2 years after you stop taking it, tell your doctor right away.
  • Teriflunomide Tablets Pregnancy Registry. If you become pregnant while taking teriflunomide tablets or during the 2 years after you stop taking teriflunomide tablets, talk to your doctor about enrolling in the Autoimmune Diseases Study pregnancy registry at 1-877-311-8972. The purpose of this registry is to collect information about your health and your baby’s health.
  • For men taking teriflunomide tablets:

• If your female partner plans to become pregnant, you should stop taking teriflunomide tablets 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 tablets. 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 are Teriflunomide Tablets?

Teriflunomide tablets are 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 tablets?

Do not take teriflunomide tablets if you:

• have had an allergic reaction to teriflunomide or a medicine called leflunomide
• have severe liver problems
• are pregnant or are of childbearing age and not using effective birth control
• take a medicine called leflunomide

What should I tell my doctor before taking teriflunomide tablets?

Before you take teriflunomide tablets, tell your doctor 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 tablets or breastfeed. You should not do both.

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

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

What are possible side effects of teriflunomide tablets?

Teriflunomide tablets may cause serious side effects, including:

• See “What is the most important information I should know about teriflunomide tablets?”

• decreases in your white blood cell count. Your white blood cell counts should be checked before you start taking teriflunomide tablets. 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 tablets. 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 tablets and for 6 months after your treatment with teriflunomide tablets ends.
• numbness or tingling in your hands or feet that is different from your MS symptoms. You have a greater chance of getting peripheral neuropathy 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.

• Allergic reactions, including serious skin problems. Tell your doctor if you have difficulty breathing, itching, swelling on any part of your body including in your lips, eyes, throat or tongue, or any skin problems such as rash or redness and peeling.
• new or worsening breathing problems. Tell your doctor if you have shortness of breath or coughing with or without fever.
• high blood pressure. Your doctor should check your blood pressure before you start taking teriflunomide tablets and while you are taking teriflunomide tablets.

  The most common side effects of teriflunomide tablets include:

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of teriflunomide tablets. 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 1-800-332-1088.

How should I store teriflunomide tablets?

• Store teriflunomide tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
• Keep teriflunomide tablets and all medicines out of reach of children.

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

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

This Medication Guide summarizes the most important information about teriflunomide tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about teriflunomide tablets that is written for healthcare professionals.

For more information, call Impax Laboratories, Inc. at 1-800-934-6729.

What are the ingredients in teriflunomide tablets?

Active ingredient: teriflunomide

Inactive ingredients in 14 mg tablets: lactose monohydrate, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The film coating for the 14 mg tablet is made of titanium dioxide, talcum, hypromellose, cottonseed oil, and FD&C Blue no. 2 Al-Lake and FD&C Red No. 40.

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

Mfd. by:
Combino Pharm Ltd.
HF60, Hal Far Industrial Estate
Hal Far, BBG 3000
MALTA

Dist. by:
Impax Generics
Hayward, CA 94544

1940-03

Iss. 06/2020