Teriflunomide

Teriflunomide is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Teriflunomide may also be used for reasons not mentioned in this medication guide.

Before you start treatment with teriflunomide, your doctor may do tests to ensure you do not have tuberculosis or other infections.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

You can take teriflunomide with or without food.

Teriflunomide can cause serious liver problems that may require a liver transplant. Your doctor will need to test your liver function up to 6 months before you begin taking teriflunomide, and then every month when you first start this medicine. Your teriflunomide treatment may be delayed or stopped based on the results.

Your blood pressure may also need to be checked frequently.

After you stop taking teriflunomide, you may need to be treated with other medicines to help your body get rid of teriflunomide quickly. If you do not go through this drug elimination procedure, teriflunomide could remain in your body for up to 2 years. Follow your doctor's instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after stopping teriflunomide.

Store at room temperature away from moisture and heat.

Do not use teriflunomide if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment.

Teriflunomide can cause serious liver problems that may lead to the need for a liver transplant. Your liver function will need to be tested before and during treatment with teriflunomide. Tell your doctor if you have a history of liver disease.

Call your doctor immediately if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

You should not use teriflunomide if you are allergic to teriflunomide or leflunomide, or if:

• you have severe liver disease; or
• you are also taking leflunomide (Arava).

Do not use teriflunomide if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment. Avoid getting pregnant until after you stop taking teriflunomide and undergo a "drug elimination" procedure to help remove this medicine from your body. Stop taking teriflunomide and call your doctor right away if you miss a period or think you might be pregnant.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a fever, or uncontrolled infections;
• numbness or tingling that is different from your usual MS symptoms;
• serious skin problems when taking medicines;
• diabetes;
• high blood pressure;
• tuberculosis; or
• breathing problems.

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking teriflunomide, continue using birth control until you have received blood tests to confirm that the drug has been eliminated from your body.

If you become pregnant while taking teriflunomide or within 2 years after you stop, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If you are a man, use effective birth control to prevent pregnancy if your sex partner is able to get pregnant. After your treatment ends, keep using birth control until you have received the medications to help your body eliminate teriflunomide.

You should not breastfeed while using this medicine.

Get emergency medical help if you notice signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Seek medical treatment if you experience a serious drug reaction that can affect multiple parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Teriflunomide may cause serious side effects. Stop using teriflunomide and call your doctor right away if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;
• trouble breathing, new or worsening cough with or without fever;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• pancreatitis--severe pain in your upper stomach that spreads to your back, nausea and vomiting;
• signs of infection--fever, chills, body aches, nausea, vomiting, feeling tired; or
• liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of teriflunomide may include:

• headache;
• nausea, diarrhea;
• thinning hair; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once a dayUse: For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

Take the medicine as soon as you can, but if it is nearly time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Stay away from people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you notice any signs of infection.

Do not get a "live" vaccine while you are taking teriflunomide, and for at least 6 months after you stop taking it. The vaccine may not work properly during this time and may not fully protect you from illness. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and the nasal flu (influenza) vaccine.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective. Your doctor may need to change the doses of any other medicines you take regularly.

Teriflunomide can harm your liver, especially if you also take certain medicines for infections, tuberculosis, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).

Tell your doctor if you take medicines that may increase your risk of getting an infection, such as cancer medicines or medicines that affect your immune system.

Many drugs can affect teriflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.