Aubagio

Aubagio

What is Aubagio?

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

Aubagio is not a cure for MS.

Warnings

Do not take Aubagio if you are pregnant or may become pregnant.A negative pregnancy test must be present before starting this treatment. Tell your doctor immediately if you become pregnant during treatment or within 2 years of stopping treatment.

Teriflunomide can cause serious liver problems. You should not use this medicine if you have severe liver disease or are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

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

Your doctor may need to test your liver function up to 6 months before you start taking Aubagio and then every month when you start taking this medicine.

Teriflunomide can lower the blood cells that help your body fight infections. This can make you more likely to get sick from interacting with others who are sick. Blood tests may be needed every six months while you are using Aubagio. Your blood pressure also needs to be checked frequently.

After you stop taking Aubagio, the medication may remain in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate teriflunomide quickly. Follow your doctor's instructions.

Before you take this medicine

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

• you have severe liver disease; or

• You also take leflunomide (Arava).

Do not take Aubagio if you are pregnant or may become pregnantA negative pregnancy test must be present before starting this treatment. Avoid pregnancy until you have stopped taking this medicine and undergo "drug elimination" to rid your body of this medicine.Stop taking Aubagio and call your doctor immediately if you miss your period or think you may be pregnant.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• high blood sugar;

• high blood pressure;

• skin problems when taking medication;

• fever or uncontrolled infections;

• difficulty breathing;

• Tuberculosis; or

• Nerve problems such as neuropathy.

Use birth control to prevent pregnancy while taking this medicine. After you stop taking Aubagio, continue using contraception until you have had blood tests to make sure the medicine has been cleared from your body.

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

If you are a man,Use effective contraception to prevent pregnancy if your sexual partner can become pregnant. After your treatment ends, continue using contraception until you have received the medication to help your body eliminate teriflunomide.

You should not breast-feed while using this medicine.

How should I take Aubagio?

Before you start treatment with Aubagio, your doctor may do tests to make sure you do not have tuberculosis or other infections.

Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You can take Aubagio with or without meals.

Your blood pressure needs to be checked frequently.

Teriflunomide can lower the number of your blood cells. Your blood will need to be checked frequently. Due to the results, your treatment may be delayed.

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

You must also go through this drug exclusion procedure if you plan to become pregnant after you stop taking this drug.

Store at room temperature, protected from moisture and heat.

Dosage information

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once daily

Use: Treatment of patients with relapsing forms of multiple sclerosis.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What to avoid

Avoid being around people with colds, flu or other contagious illnesses. Contact your doctor immediately if you notice any signs of infection.

Do not receive a live vaccine while using Aubagio and for at least 6 months after you stop taking it. During this time, the vaccine may not work as well and may not completely protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza).

Aubagio side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Aubagio(hives, difficulty breathing, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Stop using this medicine and call your doctor immediately if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;

• difficulty breathing, new or worsening cough with or without fever;

• Signs of infection –fever, chills, body aches, nausea, vomiting, fatigue; or

• Liver problems –Pain in the upper abdomen, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common Aubagio side effects 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Aubagio?

Sometimes it is not safe to take certain medications at the same time. Some medications can affect the blood levels of other medications you are taking, which may increase side effects or make the medications less effective.

Your doctor may need to adjust the dosage of any other medicines you regularly take.

Many medications can interact with teriflunomide. This includes prescription and over-the-counter medications, vitamins and herbal products. Not all possible interactions are listed here. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.