Generic Name: teriflunomide
Date of Approval: September 12, 2012
Company: Genzyme Corporation
FDA Approves Aubagio
The U.S. Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Aubagio has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).
The Aubagio label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data).
Aubagio Medication Guide
Read this Medication Guide before you start using Aubagio 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 Aubagio?
Aubagio may cause serious side effects, including:
Liver problems: Aubagio 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 Aubagio
once a month for 6 months after you start taking Aubagio
Call your doctor right away if you have any of the following symptoms of liver problems:
loss of appetite
your skin or the whites of your eyes turn yellow
Harm to your unborn baby: Aubagio may cause harm to your unborn baby. Do not take Aubagio if you are pregnant. Do not take Aubagio unless you are using effective birth control.
If you are a female, you should have a pregnancy test before you start taking Aubagio. Use effective birth control during your treatment with Aubagio.
After stopping Aubagio, continue using effective birth control until you have blood tests to make sure your blood levels of Aubagio are low enough. If you become pregnant while taking Aubagio or within 2 years after you stop taking it, tell your doctor right away.
Aubagio Pregnancy Registry. If you become pregnant while taking Aubagio or during the 2 years after you stop taking Aubagio, talk to your doctor about enrolling in the Aubagio Pregnancy Registry at 1- 800-745-4447, option 2. The purpose of this registry is to collect information about your health and your baby’s health.
For men taking Aubagio:
If your female partner plans to become pregnant, you should stop taking Aubagio and ask your doctor how to quickly lower the levels of Aubagio 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 Aubagio. Aubagio remains in your blood after you stop taking it, so continue using effective birth control until Aubagio blood levels have been checked and they are low enough.
Aubagio 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 Aubagio more quickly. Talk to your doctor if you want more information about this.
What is Aubagio?
Aubagio is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS). Aubagio can decrease the number of MS flare-ups (relapses). Aubagio does not cure MS, but it can help slow down the physical problems that MS causes.
It is not known if Aubagio is safe and effective in children.
Who should not take Aubagio?
Do not take Aubagio if you:
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 Aubagio?
Before you take Aubagio, 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 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 Aubagio passes into your breast milk. You and your doctor should decide if you will take Aubagio or breastfeed. You should not do both at the same time.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Using Aubagio and other medicines may affect each other causing serious side effects. Aubagio may affect the way other medicines work, and other medicines may affect how Aubagio works.
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 Aubagio?
Take Aubagio exactly as your doctor tells you to take it.
Take Aubagio one time each day.
Take Aubagio with or without food.
Aubagio side effects
Aubagio may cause serious side effects, including:
See What is the most important information I should know about Aubagio?
decreases in your white blood cell count. Your white blood cell counts should be checked before you start taking Aubagio. 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 Aubagio.
Tell your doctor if you have any of these symptoms of an infection:
should not receive certain vaccinations during your treatment with Aubagio and for 6 months after your treatment with Aubagio 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
Tell your doctor if you have numbness or tingling in your hands or feet that is different from your MS.
kidney problems. Tell your doctor if you have pain in your side (flank pain).
high potassium levels in your blood. Tell your doctor if you have nausea that does not go away or a racing heartbeat.
serious skin problems. Tell your doctor if you have any skin problems such as 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 Aubagio and while you are taking Aubagio.
The most common side effects of Aubagio include:
increases in the results of blood tests to check your liver
hair thinning or loss (alopecia)
burning or prickling feeling in your skin (paraesthesia)
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 Aubagio. 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 Aubagio?
Store Aubagio at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Aubagio and all medicines out of reach of children.
General information about the safe and effective use of Aubagio
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Aubagio for a condition for which it was not prescribed. Do not give Aubagio 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 Aubagio. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Aubagio that is written for healthcare professionals.
For more information, go to www.Aubagio.com or call Genzyme Medical Information Services at 1-800-745-4447, option 2.
What are the ingredients in Aubagio?
Active ingredient: teriflunomide
Inactive ingredients: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake.