WHAT IS AUBAGIO?
AUBAGIO is a once-daily pill used to treat relapsing forms of multiple sclerosis (MS).
Your healthcare provider will run certain tests before you start treatment. Once on AUBAGIO, your healthcare provider will monitor your liver enzyme levels monthly for the first six months.
IS AUBAGIO RIGHT FOR ME?
You and your healthcare provider will decide if AUBAGIO is right for you. AUBAGIO may be used in people with relapsing forms of MS who are:
- Newly diagnosed or have never used treatment
- Switching therapy due to disease activity
- Changing therapy because of side effects from current MS treatment
- Dissatisfied with current treatment
Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis.
HOW DOES AUBAGIO WORK?
AUBAGIO works differently than other MS therapies. It is believed to block the replication of overactive immune cells (including T- and B-cells) that attack and damage the nerves in the central nervous system (CNS). The exact way AUBAGIO works in relapsing MS is not known.
HOW EFFECTIVE IS AUBAGIO?
In clinical trials, AUBAGIO was proven to be effective in reducing relapses, slowing disability progression, and decreasing lesions.
To learn more about the efficacy data for AUBAGIO, click here.
What tests do I need before starting therapy?
Your healthcare provider will need to run a few tests within 6 months before you can begin AUBAGIO:
- Perform blood tests to check your liver
- Obtain a complete blood count
- Perform a TB (tuberculosis) skin test or blood test for mycobacterium tuberculosis infection
- Check your blood pressure
- Perform a pregnancy test, if you are a woman of childbearing potential
WHAT IF I WANT TO TAKE AUBAGIO BUT I'M PREGNANT?
Do not take AUBAGIO if you are pregnant. AUBAGIO may harm an unborn baby. Always talk to your healthcare provider about all your medications if you are pregnant.
WHAT IF I GET PREGNANT WHILE TAKING AUBAGIO?
If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry by calling 1‑800‑745‑4447, then press option 2. The purpose of the registry is to collect information about your health and your baby’s health.
In addition, there is a process called accelerated elimination to help you remove AUBAGIO from your blood if needed. Without using accelerated elimination, AUBAGIO may stay in your blood for up to 2 years after you stop using it.
WHAT IF I AM ON AUBAGIO AND WANT TO GET PREGNANT?
Women who are pregnant or not using effective birth control should not take AUBAGIO because it's possible that AUBAGIO may harm your unborn baby.
If you become pregnant while taking AUBAGIO, tell your healthcare provider right away. A process called accelerated elimination helps remove AUBAGIO from your blood if needed. It is recommended that you continue using birth control until the level of AUBAGIO is lower than 0.02 mg/L in your blood.
It is not known if AUBAGIO passes into breast milk. Your healthcare provider can help you decide if you should take AUBAGIO or breastfeed—you should not do both at the same time.
WHAT IF I AM A MAN WITH A FEMALE PARTNER AND WE WOULD LIKE TO CONCEIVE?
If you are a man whose partner plans to become pregnant, you should stop taking AUBAGIO and talk with your healthcare provider about reducing the levels of AUBAGIO in your blood.
WHAT ARE THE SIDE EFFECTS OF AUBAGIO?
AUBAGIO may cause serious side effects, including: reduced white blood cell count — this may cause you to have more infections; numbness or tingling in your hands or feet that is different from your MS symptoms; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.
Tell your doctor if you have any side effect that bothers you or does not go away.
The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results. These are not all the side effects of AUBAGIO. Tell your healthcare provider about any side effect that bothers you.
WILL I HAVE FLUSHING?
Flushing was not a common side effect reported in AUBAGIO clinical trials. However, not every individual reacts the same to medicine. Tell your healthcare provider about any side effect that you experience.
WILL I HAVE DIARRHEA?
Not every individual reacts the same to medicine. In AUBAGIO clinical trials, up to 14% of patients on AUBAGIO had diarrhea versus 8% of patients on placebo. Most cases of diarrhea were mild to moderate and not persistent. Tell your healthcare provider about any side effect that you experience.
WILL AUBAGIO CAUSE HAIR THINNING OR HAIR LOSS?
Hair thinning or hair loss was a side effect of AUBAGIO reported in clinical trials. 87% of patients on AUBAGIO 14 mg and 90% of patients on AUBAGIO 7 mg did not report hair thinning or hair loss. In most cases, hair thinning or hair loss was mild to moderate, had a median time to onset of 99 days, and improved without corrective therapy while patients remained in the clinical trials. Tell your healthcare provider about any side effect that you experience.
WHAT TESTS DO I NEED WHILE TAKING AUBAGIO?
Your healthcare provider will:
- Monitor your liver enzyme levels monthly for the first 6 months
- Check your blood pressure periodically after starting treatment
Work with your healthcare provider to schedule these appointments.
HOW DO I GET MY MEDICATION OUT OF THE PACKAGE?
The following instructions are for the 28-day supply of AUBAGIO:
- The AUBAGIO blister pack is contained in an outer box. To open the box, use your thumb to depress the perforated tab at the top
- Pull back the top of the box and remove the blister pack
- To remove your daily AUBAGIO pill, use your thumb to push down from the top and tear through the individual blister
DOES AUBAGIO NEED TO BE REFRIGERATED?
No, but it should be stored at room temperature 68°F to 77°F (20°C to 25°C). Make sure to keep AUBAGIO out of the reach of children.
WHAT IF I MISS TAKING A DOSE?
If you miss a pill, you should follow your set schedule and take your next pill as normal. There is no need to 'double up' a dose to make up for a missed dose. It is important to take your medication as prescribed. If you have concerns about missing a dose(s), please talk to your healthcare provider.
IS THERE FINANCIAL ASSISTANCE FOR AUBAGIO? WHAT ARE THE ELIGIBILITY REQUIREMENTS?
The financial assistance programs for those with primary commercial insurance are:
- AUBAGIO Co-Pay Program
- One Start®
The financial assistance programs for individuals without insurance and who meet other eligibility requirements:
- Patient Assistance Program (PAP)
- External support agencies, like NORD or the Assistance Fund
You can get help figuring out coverage from an MS One to One® Nurse.
WHAT IS MS One to One®?
Whether you’re having a good day or a bad day, your MS One to One® Nurse is just a phone call away. He or she can give you and your care partners tailored information and useful suggestions about living with relapsing MS, facts regarding your AUBAGIO treatment and potential side effects, answers and support, and even helpful education resources.
WHAT EVENTS ARE OFFERED FOR PEOPLE LIVING WITH MS?
Sanofi Genzyme sponsors free local events with topics focusing on the disease and on living with MS.