Here are answers to some of the most frequently asked questions about branded AUBAGIO

Yes. The patent exclusivity of branded AUBAGIO has ended. This means generic versions of AUBAGIO are available. These generic versions will go by the generic name teriflunomide.

Yes. Sanofi remains committed to branded AUBAGIO patients and the treatment of relapsing MS. If your preference is to stay with branded AUBAGIO, it is available and will continue to be available.

Talk to your pharmacist about your preference and discuss including “DAW” on AUBAGIO prescriptions with your doctor. Including “DAW” (dispense as written) helps communicate your preference to the pharmacy.

While not identical, the FDA requires that the active ingredient in a generic substitute must be comparable in quality and efficacy to branded AUBAGIO.

Now that generic teriflunomide is available, your insurance company or pharmacy may switch you to a generic. Switching to a generic can impact you in the following ways:

• The medication and packaging you receive may look different from AUBAGIO
• You will no longer have access to the assistance and support from MS One to One that you may currently receive
• Your out-of-pocket costs may change, and any financial support from the AUBAGIO Co-Pay Program will no longer be available to you

MS One to One will continue to be available to support branded AUBAGIO patients through at least 2023.*

*Sanofi plans and programs may be changed or modified at any time

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Branded AUBAGIO comes in 7 mg and 14 mg. Your doctor will determine your dosage. Both dosages are once-daily pills to be taken orally. A bottle of branded AUBAGIO will contain a 30-day supply and state clearly on the label: AUBAGIO (teriflunomide).

The 7 mg pill is light greenish-blue grey to pale greenish-blue, 6 sided, and stamped with a 7 on one side. The 14 mg pill is pale blue to pastel blue, 5 sided, and stamped with a 14 on one side.

The pills and packaging of generic teriflunomide may look different than what is described above. Please consult with your pharmacist if you have any questions about what medication you have received.

1. Ask your doctor to specifically prescribe branded AUBAGIO by including “DAW” (dispense as written)—or the language used in your state—on all of your AUBAGIO prescriptions.
2. Call your specialty pharmacy to make sure your pharmacist knows you want to continue with branded AUBAGIO.

Speak with your specialty pharmacist to let them know that you prefer brand-name AUBAGIO. If this does not resolve the issue, your doctor may be able to submit a letter of medical necessity to provide a rationale for why branded AUBAGIO is needed.

AUBAGIO is a once-daily pill 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 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.

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.

Your specialty pharmacy will make sure that your branded AUBAGIO is sent to the correct location. It’s important to remember and track when this delivery will arrive.

Upon arrival at your home or building, follow these recommendations:

• Do not leave your AUBAGIO package outside, especially during warm, cold, or inclement weather
• Ask a trusted adult neighbor or friend to securely take in your AUBAGIO package for you if you won’t be home when it arrives
• Keep your AUBAGIO at room temperature 68 °F to 77 °F (20 °C to 25 °C)
• Make sure to keep AUBAGIO out of the reach of children

Available in 7 mg AND 14 mg Pill is not actual size

When you receive branded AUBAGIO, it will be in a bottle that contains 30 days of medication, in either 7 mg or 14 mg tablets. Your healthcare provider will choose the dose that’s right for you. Whichever dose you are prescribed, it is taken the same way.

You can take branded AUBAGIO:

Once a
day

With or without
food

Any time of day
that works for you

If you have any further questions, call MS One to One at 1-855-676-6326

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.

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.

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 1-855-676-6326, 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.

The AUBAGIO Co-Pay Program is available to help eligible patients with co-pay costs for those with primary commercial insurance.*

Sign up for your AUBAGIO Co-Pay Card

Individuals without insurance, who meet other eligibility requirements, can apply to the Sanofi Patient Connection^® Program for financial assistance.

Contact MS One to One

MS One to One is a program providing nurse support and financial assistance to branded AUBAGIO patients and will continue to be available at least through 2023.* Being on branded AUBAGIO is the only way to receive patient support through MS One to One.

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