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Here are answers to some of the most common questions we hear

Below you’ll find some frequently asked questions about branded AUBAGIO® (teriflunomide) and relapsing MS. If you have questions beyond what appears below, or if you find an answer is unclear, please call one of our MS One to One Nurses at 1-855-676-6326.

AUBAGIO basics

AUBAGIO is a once-daily pill prescription used to treat relapsing forms of multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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You and your healthcare provider will decide if AUBAGIO is right for you. AUBAGIO is an option for people with relapsing MS who are:

  • Newly diagnosed or have never used treatment
  • Switching therapy due to disease activity
  • Changing therapy because of side effects from current relapsing 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.

While we don’t fully understand how AUBAGIO works in relapsing MS, we do know that it works differently from other relapsing MS medicines. AUBAGIO is believed to block the enzyme needed for specific immune cells to keep multiplying at an overactive rate.

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In clinical trials, AUBAGIO 14 mg was proven to be effective vs. placebo in reducing relapses, slowing disability progression, and decreasing the number of new lesions. AUBAGIO 7 mg was shown to be effective vs placebo in reducing relapses and new lesions.

To learn more about the efficacy data for AUBAGIO, CLICK HERE.

Taking AUBAGIO

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 prior to starting AUBAGIO, if you are a woman of childbearing potential

Your healthcare provider will:

  1. Monitor your liver enzyme levels monthly for the first 6 months
  2. Check your blood pressure periodically after starting treatment

Work with your healthcare provider to schedule these appointments.

No, but it should be stored at room temperature from 68°F to 77°F (20°C to 25°C). Make sure to keep AUBAGIO out of the reach of children.

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 in order to get the full benefit of AUBAGIO. If you have concerns about missing a dose(s), please talk to your healthcare provider.

Possible 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. People with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

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.

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Hair thinning or 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 experiencing hair thinning or loss. 13% of patients on AUBAGIO 14 mg and 10% of patients on AUBAGIO 7 mg did report experiencing hair thinning or hair loss. In clinical trials, about 1 in 20 people taking placebo (5% of 997 patients) reported experiencing hair thinning or hair loss. In most cases, hair thinning or hair loss was mild to moderate, may occur around 3 months after starting treatment, and was usually temporary. Tell your healthcare provider about any side effects you experience while taking AUBAGIO.

AUBAGIO is a once-daily pill with infection rates similar to placebo.
AUBAGIO may cause decreases in your white blood cell count. When you have a low white blood cell count you may have more frequent infections. Infection rates were similar with AUBAGIO vs. placebo in clinical trials. One death due to Klebsiella pneumoniae sepsis occurred in a patient taking AUBAGIO 14 mg for 1.7 years. In clinical trials with AUBAGIO, cytomegalovirus hepatitis reactivation and cases of TB (tuberculosis) have been observed. AUBAGIO has no progressive multifocal leukoencephalopathy (PML) in its Prescribing Information.

Balancing treatment with family planning

Do not take AUBAGIO if you are pregnant. AUBAGIO may harm an unborn baby. If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your healthcare provider right away.

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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 in your blood than 0.02 mg/L.

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.

If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your healthcare provider right away. 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. In addition, you can 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.

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.

Support

The financial assistance program 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)

You can get help figuring out coverage from an MS One to One® Nurse. Just call 1-855-676-6326.

*Out-of-pocket costs related to medication, appointments, evaluations, testing or other related services are not covered by the AUBAGIO Co-Pay Program. The AUBAGIO Co-Pay Program is not available for prescriptions purchased under Medicare, Medicaid, TRICARE, or other federal- and state-funded programs. Sanofi reserves the right to amend or terminate the Program at any time without notice. The maximum annual patient benefit under the AUBAGIO Co-Pay Program is $18,000. Co-pay amounts after applying co-pay assistance may depend on the patient’s insurance plan and may vary. The AUBAGIO Co-Pay Program is intended to help patients afford AUBAGIO. Patients may have insurance plans that attempt to dilute the impact of the assistance available under the AUBAGIO Co-Pay Program. In those situations, the AUBAGIO Co-Pay Program may change its terms.

MS One to One is a support program aimed at empowering those living with relapsing multiple sclerosis and taking AUBAGIO. The program is available to people living with MS, their care partners, and their healthcare providers. MS One to One is always available by phone to assist you and answer questions you may have.

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INDICATION

AUBAGIO® (teriflunomide) is 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.

IMPORTANT SAFETY INFORMATION

DO NOT TAKE AUBAGIO IF YOU:

  • Have severe liver problems. AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. Your risk may be higher if you already have liver problems or take other medicines that affect your liver. Your healthcare provider should do blood tests to check your liver within 6 months before you start AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your healthcare provider right away if you develop any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of your skin or whites of your eyes, or dark urine.
  • Are pregnant. AUBAGIO may harm an unborn baby. You should have a pregnancy test before starting AUBAGIO. After stopping AUBAGIO, continue to use effective birth control until you have made sure your blood levels of AUBAGIO are lowered. If you become pregnant while taking AUBAGIO or within 2 years after stopping, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option 2.
  • Are of childbearing potential and not using effective birth control.

    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.

    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. If your partner does not plan to become pregnant, use effective birth control while taking AUBAGIO.

  • Have had an allergic reaction to AUBAGIO or a medicine called leflunomide.
  • Take a medicine called leflunomide for rheumatoid arthritis.

AUBAGIO may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine that can remove AUBAGIO from your blood quickly.

Before taking AUBAGIO, talk with your healthcare provider if you have: liver or kidney problems; a fever or infection, or if you are unable to fight infections; numbness or tingling in your hands or feet that is different from your MS symptoms; diabetes; serious skin problems when taking other medicines; breathing problems; or high blood pressure. Your healthcare provider will check your blood cell count and TB test before you start AUBAGIO. Talk with your healthcare provider if you take or are planning to take other medicines (especially medicines for treating cancer or controlling your immune system), over-the-counter medicines, vitamins or herbal supplements.

AUBAGIO may cause serious side effects. Tell your doctor if you have any of the following:

  • decreases in white blood cell count — this may cause you to have more infections. Symptoms include fever, tiredness, body aches, chills, nausea, or vomiting. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.
  • allergic reactions such as difficulty breathing, itching, or swelling on any part of your body including lips, eyes, throat, or tongue. Stop taking AUBAGIO and call your doctor right away.
  • serious skin reactions that may lead to death. Stop taking AUBAGIO if you have rash or redness and peeling, mouth sores or blisters.
  • other allergic reactions that may affect different parts of the body. If you have a fever or rash in combination with severe muscle pain, swollen lymph glands, swelling of your face, unusual bruising or bleeding, weakness or tiredness, or yellowing of your skin or the whites of your eyes, stop taking AUBAGIO and call your doctor right away.
  • numbness or tingling in your hands or feet that is different from your MS symptoms
  • high blood pressure
  • breathing problems (new or worsening) — these may be serious and lead to death

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.

Consult your healthcare provider if you have questions about your health or any medications you may be taking, including AUBAGIO.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

IMPORTANT SAFETY INFORMATION
Do not take AUBAGIO if you have severe liver problems. AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. Your risk may be higher if you already have liver problems or take other medicines that affect your liver. Your healthcare provider should do blood tests to check your liver within 6 months before you start AUBAGIO and monthly for 6 months after starting AUBAGIO. View More