Aubagio: Side Effects, Cost, Uses, and More

Aubagio is a brand-name prescription medication. It's used to treat relapsing forms of multiple sclerosis (MS) in adults. MS is an illness in which your immune system attacks your central nervous system.

Aubagio contains the drug teriflunomide, which is a pyrimidine synthesis inhibitor. Drugs in this class help prevent immune cells from quickly multiplying. This action helps decrease inflammation (swelling).

Aubagio comes as a tablet that you swallow. The drug is available in two strengths: 7 mg and 14 mg.

Aubagio was compared to a placebo (no treatment) in four clinical trials. People who took Aubagio had:

• fewer relapses (flare-ups)
• slower progression of disability (their physical disability didn't worsen as quickly)
• a lower risk for new lesions (scar tissue) in the brain

For specific information from these studies, see the 'Aubagio uses' section.

Aubagio is currently available only as a brand-name medication.

Aubagio contains the active ingredient teriflunomide. In 2018, the Food and Drug Administration (FDA) approved a generic version of teriflunomide, but it's not available yet.

Aubagio can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Aubagio. This list does not include all possible side effects.

For more information on the possible side effects of Aubagio, talk with your doctor or pharmacist. They can give you tips on how to deal with any bothersome side effects.

More common side effects

The more common side effects of Aubagio can include:

• headache
• alopecia (hair thinning or hair loss)
• decreased phosphate levels
• decreased levels of white blood cells
• nausea
• diarrhea
• increased levels of liver enzymes (can be a sign of liver damage)
• increased blood pressure
• numbness or tingling in your hands or feet
• joint pain

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include the following:

• Allergic reactions. Symptoms can include:
  • swelling in your face or hands
  • itching or hives
  • swelling or tingling in your mouth or throat
  • chest tightness
  • trouble breathing
• Liver damage, including liver failure. Symptoms of liver problems can include:
  • nausea
  • vomiting
  • pain in your abdomen
  • loss of appetite
  • tiredness
  • dark urine
  • yellowing of your skin or the whites of your eyes
• Low levels of white blood cells. Symptoms can include:
  • fever
  • tiredness
  • body aches
  • chills
  • nausea
  • vomiting
• Serious skin reactions. Symptoms can include:
  • Stevens-Johnson syndrome (painful sores on your mouth, throat, eyes, or genitals)
  • unexplained bruising or bleeding
  • swelling
  • blistered or peeling skin
  • sores in your mouth, eyes, nose, or throat
• High blood pressure. Symptoms can include:
  • headache
  • fatigue or confusion
  • vision changes
  • irregular heartbeat
• Respiratory problems, including interstitial lung disease. Symptoms can include:
  • shortness of breath
  • coughing with or without a fever

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here's some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Aubagio. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness

A more severe allergic reaction is rare but possible. Symptoms of a serious allergic reaction can include:

• angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
• swelling of your tongue, mouth, or throat
• trouble breathing
• red or peeling skin

Call your doctor right away if you have a severe allergic reaction to Aubagio. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Skin problems/rash

Aubagio can cause serious skin reactions. These include Stevens-Johnson syndrome, which is a medical emergency. It causes painful sores on your mouth, throat, eyes, or genitals.

It was reported that one person who took Aubagio developed toxic epidermal necrolysis (TEN), which was fatal. TEN is Stevens-Johnson syndrome that affects more than 30% of your body. It begins as a painful rash with flu-like symptoms, and then blisters develop.

If your skin peels or becomes red, swollen, or blistered, tell your doctor right away. If you have Stevens-Johnson syndrome or TEN, you may need to be hospitalized.

Liver damage

In clinical trials, about 6% of people who took Aubagio had increased levels of liver enzymes. About 4% of people who had a placebo (no treatment) had increased liver enzyme levels.

Aubagio can increase levels of liver enzymes, which can be a sign of serious liver problems. Tell your doctor if you have any of these symptoms:

• nausea
• vomiting
• pain in your abdomen
• loss of appetite
• tiredness
• dark urine
• yellowing of your skin or the whites of your eyes

Before you start to take Aubagio, your doctor will give you a blood test to check your liver function. They'll also give you monthly tests while you take Aubagio to see how your liver is working.

Hair loss

One of the most common side effects of Aubagio is alopecia (hair thinning or hair loss).

In clinical trials, about 13% of people who took Aubagio had alopecia. Most people had symptoms of alopecia within three months of taking the drug. Alopecia lasted less than six months on average. This side effect was temporary, and most of the cases improved as people continued taking Aubagio.

If you're taking Aubagio and are concerned about hair loss, talk with your doctor.

Diarrhea

Diarrhea is a common side effect of Aubagio.

In clinical trials, about 14% of people who took Aubagio had diarrhea. This was compared to 8% of people who had a placebo (no treatment). Most cases of diarrhea were mild to moderate and went away on their own.

To treat mild diarrhea, drink plenty of water or electrolyte solutions to help your body replace lost fluids. If your diarrhea lasts several days, call your doctor. They can suggest ways to ease your symptoms.

PML (not a side effect)

Progressive multifocal leukoencephalopathy (PML) isn't a side effect of Aubagio. PML is a disease that attacks your central nervous system.

In a case report, one person developed PML after switching to Aubagio from natalizumab, a medication that's used to treat multiple sclerosis (MS). The drug natalizumab has a boxed warning from the Food and Drug Administration (FDA) regarding the increased risk of developing PML. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

It's very unlikely that Aubagio caused the person to develop PML. It's possible that the natalizumab caused it.

If you switch to Aubagio after taking natalizumab, your doctor will screen you for PML.

Fatigue (not a side effect)

Fatigue (lack of energy) isn't a common side effect of Aubagio. However, fatigue is a common symptom of multiple sclerosis (MS). Fatigue may also be a sign of liver damage.

If you're concerned about fatigue while taking Aubagio, talk with your doctor. They can explore potential causes and suggest ways to boost your energy.

Weight loss or weight gain (not a side effect)

Weight loss and weight gain weren't side effects of Aubagio in clinical studies. You won't likely lose or gain weight while taking Aubagio.

However, one of the most common symptoms of multiple sclerosis (MS) is fatigue (lack of energy). When your energy level is low, you may not be as active. This can lead you to gain weight. If you also have depression, you may tend to eat too much or too little, which can lead to weight gain or weight loss.

If you're concerned about changes in your weight, talk with your doctor. They can suggest helpful diet tips or recommend a dietitian to help make sure you get the proper nutrition.

Cancer (not a side effect)

Taking medication that affects your immune system, such as Aubagio, may increase your risk for cancer. However, clinical trials for Aubagio didn't report an increase in the number of people who developed cancer.

If you're concerned about developing cancer, talk with your doctor.

Depression (not a side effect)

Depression isn't a side effect of Aubagio. However, depression is a common symptom of MS.

If you have symptoms of depression, let your doctor know. Several antidepressant drugs are available that may help ease your symptoms.

As with all medications, the cost of Aubagio can vary. To find current prices for Aubagio in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you would pay without insurance. The actual price you'll pay will depend on your insurance coverage, your location, and the pharmacy you use.

Financial assistance

If you need financial support to pay for Aubagio, help is available. Genzyme Corporation, the maker of Aubagio, offers the Aubagio Co-Pay Program. For more information and to find out if you're eligible for support, call 855-676-6326 or visit the program website.

The Food and Drug Administration (FDA) approves prescription drugs such as Aubagio to treat certain conditions.

Aubagio for MS

Aubagio is FDA-approved to treat adults with relapsing forms of multiple sclerosis (MS). MS is a chronic (long-term) disease that causes your immune system to attack the myelin (outer layer) on nerves in your eyes, brain, and spine. This creates scar tissue, which makes it hard for your brain to send signals to other parts of your body.

In a clinical trial, more than 1,000 people who had MS relapses (flare-ups) took Aubagio or a placebo (no treatment). In the Aubagio group, 57% of them stayed relapse-free while taking the drug. This was compared to 46% of the placebo group. People who took Aubagio also had 31% fewer relapses than people who took a placebo.

The same clinical trial showed that, compared with the placebo group, people who took Aubagio had:

• only one relapse every six years while taking the drug
• slower progression of disability (their physical disability didn't worsen as quickly)
• fewer new lesions (scar tissue) in the brain

Other studies have examined how effective Aubagio is:

• In one clinical trial, about 72% of people who took Aubagio stayed free of relapses during the study. This was compared to 62% of people who took a placebo.
• Two clinical studies looked at people with relapsing MS. In one study, those who took Aubagio had 31% fewer relapses than people who took a placebo. In the other study, that figure was 36%.
• In clinical trials, at least 80% of people who took Aubagio had no progression in their disability. This means that their physical disability didn't worsen as quickly. For most of these people, this effect lasted for up to 7.5 years.

In another clinical study, people took Aubagio in 14-mg or 7-mg doses. Researchers found that compared to people who took a placebo:

• 80% of people in the 14-mg dose group had fewer new lesions
• 57% of people in the 7-mg dose group had fewer new lesions

There's no known interaction between Aubagio and alcohol. However, drinking alcohol while taking Aubagio might increase your risk for some side effects, such as:

• nausea
• diarrhea
• headache

Drinking too much alcohol while taking Aubagio might also increase your risk for liver damage.

If you take Aubagio, talk with your doctor about whether it's safe to drink alcohol.

Aubagio can interact with several other medications. It can also interact with certain supplements and foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Aubagio and other medications

Below is a list of medications that can interact with Aubagio. This list does not contain all drugs that may interact with Aubagio.

Before taking Aubagio, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Aubagio and flu vaccine

It's safe to get a flu shot while you take Aubagio. The flu vaccine is inactive, which means it's made from a germ that's been killed.

A live vaccine, on the other hand, is one that contains a weakened form of a germ. If you have a weakened immune system, you're typically advised against receiving live vaccines. This is because on very rare occasions, live vaccines can change back to the full-strength germ that causes a disease. If this happens, people with weakened immune systems would have a much higher risk for developing the disease that the vaccine is meant to prevent.

If you're taking Aubagio, you shouldn't get live vaccines. Aubagio may weaken your immune system, so getting a live vaccine may put you at risk for the illness the vaccine is supposed to protect you from.

If you have any questions about getting vaccines while taking Aubagio, talk with your doctor.

Aubagio and leflunomide

Arava (leflunomide) is a drug that's used to treat rheumatoid arthritis (RA). Taking Aubagio with leflunomide may increase the amount of Aubagio in your body. This can harm your liver. Don't take Aubagio and leflunomide together.

If you're taking Arava and need to take Aubagio, talk with your doctor. They may suggest a different RA medication.

Aubagio and warfarin

Taking Aubagio with warfarin may make warfarin less effective (not work as well in your body). As a result, your blood may be more likely to clot.

If you're taking warfarin, talk with your doctor. They'll test your blood before and during your treatment with Aubagio.

Aubagio and immunosuppressants

Certain medications, such as cancer drugs, can weaken your immune system. They're called immunosuppressants. Aubagio may weaken your immune system, too. If you take a cancer drug along with Aubagio, your immune system may not be strong enough to fight germs. This can increase your risk for infections.

Examples of these medications include:

• bendamustine (Bendeka, Treanda, Belrapzo)
• cladribine (Mavenclad)
• erlotinib (Tarceva)

If you're taking a cancer drug or another drug that suppresses your immune system, talk with your doctor. They may consider changing your treatment plan.

Aubagio and oral contraceptives

Oral contraceptives (birth control pills) are medications that help prevent pregnancy. Taking Aubagio with certain birth control pills may increase your body's levels of the hormones in the birth control pills. This could cause an imbalance in your hormone levels.

Examples of these medications include:

• ethinyl estradiol
• levonorgestrel(Plan B One-Step, Mirena, Skyla)
• ethinyl estradiol/levonogestrel (Lutera, Vienva)

If you're taking birth control pills, talk with your doctor. They can recommend a type that won't react as strongly with Aubagio.

Aubagio and cholesterol-lowering medications

Taking Aubagio with certain cholesterol-lowering medications may increase the levels of these medications in your body. This can cause increased side effects from the cholesterol medication.

Examples of these medications include:

• atorvastatin (Lipitor)
• pravastatin (Pravachol)
• simvastatin (Zocor, FloLipid)
• rosuvastatin

If you're taking a medication to lower your cholesterol, talk with your doctor. They'll likely check your dosage of each drug and ensure that they're safe to take together.

Aubagio and other drugs

Aubagio can interact with many different medications. And some of these medications can affect how Aubagio works. This is because your body metabolizes (breaks down) Aubagio and many other drugs in a similar way. When medications are broken down together, they can sometimes interact with each other.

Aubagio can cause your body to break down some drugs quickly or slowly. This can increase or decrease the levels of those drugs in your body. If it increases the levels, it can raise your risk of side effects. If it decreases the levels, the drug may not work as well.

Examples of these medications include:

• amodiaquine
• asunaprevir
• Bacillus Calmette-Guerin (BCG)
• elagolix (Orilissa)
• grazoprevir
• natalizumab (Tysabri)
• pazopanib (Votrient)
• pimecrolimus (Elidel)
• revefenacin (Yupelri)
• topical tacrolimus
• topotecan (Hycamtin)
• voxilaprevir

If you're taking any of these medications, talk with your doctor. They'll monitor the levels of these drugs in your body while you take Aubagio.

The Aubagio dosage your doctor prescribes will depend on several factors. These may include:

• the type and severity of the condition you're taking Aubagio for
• your age
• the form of Aubagio you take
• other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they'll adjust it over time to reach the dosage that's right for you. They'll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Aubagio comes as a tablet that you swallow. It's available in two strengths: 7 mg and 14 mg.

Dosage for relapsing forms of MS

Your doctor may start you on 7 mg, once a day. If this starting dose doesn't work for you, they may increase the dosage to 14 mg, once a day.

What if I miss a dose?

If you miss a dose, take your missed dose as soon as you remember. If you're close to the time for your next dose, skip the missed dose and go back to your normal time. Don't take two doses at the same time or any extra doses.

Will I need to use this drug long term?

Aubagio is meant to be used as a long-term treatment for relapsing forms of multiple sclerosis. If you and your doctor determine that Aubagio is safe and effective for you, you'll likely take it long term. Be sure to take the medication exactly as your doctor tells you to.

Other drugs are available that can treat relapsing forms of multiple sclerosis (MS). Some may be better suited for you than others. If you're interested in finding an alternative to Aubagio, talk with your doctor to learn more about other medications that may work well for you.

Examples of other drugs that may be used to treat relapsing forms of MS include:

• beta interferons (Rebif, Avonex)
• ocrelizumab (Ocrevus)
• dimethyl fumarate (Tecfidera)
• glatiramer acetate (Copaxone)
• fingolimod (Gilenya)
• natalizumab (Tysabri)
• alemtuzumab (Lemtrada)
• mitoxantrone

You may wonder how Aubagio compares to other medications that are prescribed for similar uses. Here we look at how Aubagio and Tecfidera are alike and different.

Ingredients

Aubagio contains the active ingredient teriflunomide. It belongs to the pyrimidine synthesis inhibitor drug class.

Tecfidera contains a different active ingredient, dimethyl fumarate. It belongs to the disease-modifying therapy drug class.

Uses

The Food and Drug Administration (FDA) has approved both Aubagio and Tecfidera to treat relapsing forms of multiple sclerosis (MS).

Drug forms and administration

Aubagio comes as a tablet. You take it by mouth (you swallow it) once a day.

Tecfidera comes as a capsule. You take it by mouth (you swallow it) twice a day.

Side effects and risks

Aubagio and Tecfidera work in different ways but have some similar side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

These lists contain examples of more common side effects that can occur with Aubagio, with Tecfidera, or with both drugs (when taken individually).

• Can occur with Aubagio:
  • alopecia (hair thinning or hair loss)
  • increased levels of liver enzymes (can be a sign of liver damage)
  • headache
  • decreased phosphate levels
  • numbness or tingling in your hands or feet
  • joint pain
• Can occur with Tecfidera:
  • flushing (warmth and redness in your skin)
  • skin rash
  • pain in your abdomen
• Can occur with both Aubagio and Tecfidera:
  • nausea
  • diarrhea

Serious side effects

These lists contain examples of serious side effects that can occur with Aubagio, with Tecfidera, or with both drugs (when taken individually).

• Can occur with Aubagio:
  • other serious skin reactions, such as Stevens-Johnson syndrome (painful sores on your mouth, throat, eyes, or genitals)
  • increased blood pressure
• Can occur with Tecfidera:
  • progressive multifocal leukoencephalopathy (PML), a viral disease of the central nervous system
• Can occur with both Aubagio and Tecfidera:
  • liver damage
  • liver failure
  • low levels of white blood cells
  • severe allergic reaction

Effectiveness

Multiple sclerosis (MS) is the only condition that both Aubagio and Tecfidera are used to treat.

A clinical study directly compared how effective Aubagio and Tecfidera were in treating MS. Researchers looked at magnetic resonance imaging (MRI) scans of people who took either drug. Of the people who took Aubagio, 30% had new or larger lesions (scar tissue). This was compared to 40% of people who took Tecfidera.

The two medications were similarly effective. However, when looking at how the drugs affected the brain overall, Aubagio had better results than Tecfidera.

That said, because there were only 50 people in the study, more research is needed to make a definitive comparison between the two drugs.

Costs

Aubagio and Tecfidera are both brand-name drugs. They don't have generic forms. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Tecfidera generally costs more than Aubagio. The actual cost you pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

In addition to Tecfidera (above), Gilenya is also used to treat multiple sclerosis. Here we look at how Aubagio and Gilenya are alike and different.

Uses

The Food and Drug Administration (FDA) has approved both Aubagio and Gilenya to treat adults with relapsing forms of multiple sclerosis (MS). But Gilenya has also been approved to treat MS in children as young as age 10 years.

Aubagio contains the active ingredient teriflunomide. Gilenya contains a different active ingredient, fingolimod hydrochloride. These two medications aren't in the same drug class, so they work in different ways to treat MS.

Drug forms and administration

Aubagio comes as a tablet that you swallow. You take the drug once a day. Gilenya comes as a capsule that you swallow. You take the drug once a day.

Side effects and risks

Aubagio and Gilenya work in different ways but have some similar side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

These lists contain examples of more common side effects that can occur with Aubagio, with Gilenya, or with both drugs (when taken individually).

• Can occur with Aubagio:
  • alopecia (hair thinning or hair loss)
  • nausea
  • numbness or tingling in your hands or feet
  • joint pain
  • decreased phosphate levels
• Can occur with Gilenya:
  • pain in your abdomen
  • flu
  • backache
  • cough
• Can occur with both Aubagio and Gilenya:
  • diarrhea
  • increased levels of liver enzymes (which can be a sign of liver damage)
  • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Aubagio, with Gilenya, or with both drugs (when taken individually).

• Can occur with Aubagio:
  • serious skin reactions, such as Stevens-Johnson syndrome (painful sores on your mouth, throat, eyes, or genitals)
  • birth defects
  • low levels of white blood cells
  • allergic reactions
• Can occur with Gilenya:
  • skin cancer
  • vision problems
  • sudden confusion
• Can occur with both Aubagio and Gilenya:
  • increased blood pressure
  • breathing problems
  • liver damage
  • liver failure

Effectiveness

In a clinical study, Aubagio was directly compared to Gilenya in people with multiple sclerosis (MS). People who took Gilenya had 0.18 MS relapses each year, while people who took Aubagio had 0.24 MS relapses each year. But the two drugs were similarly effective in slowing the progression of disabilities. This means that people's physical disability didn't worsen as quickly.

Costs

Aubagio and Gilenya are both brand-name drugs. They don't have generic forms. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Gilenya generally costs more than Aubagio. The actual cost you pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

You should take Aubagio as your doctor or healthcare provider tells you to.

Timing

Take Aubagio once a day at about the same time each day.

Taking Aubagio with food

You can take Aubagio with or without food. Taking this medication with food won't affect how the drug works in your body.

Can Aubagio be crushed, chewed, or split?

It is not recommended that Aubagio be crushed, split, or chewed. There haven't been any studies done to determine if doing these things would change how Aubagio works in the body.

The active drug in Aubagio, teriflunomide, is known to carry a bitter taste, so it's highly recommended that you take Aubagio whole.

What tests will I need before starting treatment?

Before you take Aubagio, your doctor will run tests to make sure the drug is safe for you. These include:

• Blood tests to see whether your liver is healthy enough.
• A tuberculosis (TB) skin test or blood test to check for TB.
• A complete blood count to check for disease, including progressive multifocal leukoencephalopathy (PML). (See the 'Side effect details' section above to learn more about PML.)
• A pregnancy test. You shouldn't take Aubagio if you're pregnant.
• A blood pressure check. Taking Aubagio may increase your blood pressure, so your doctor will see if you already have high blood pressure.
• Magnetic resonance imaging (MRI) before and while you take Aubagio. Your doctor will check your brain for any changes in lesions (scar tissue).

While you take Aubagio, your doctor will give you monthly blood tests to check your liver. They'll also keep track of your blood pressure.

Multiple sclerosis (MS) is a chronic (long-term) disease. It causes your immune system to attack the myelin (outer layer) on nerves in your eyes, brain, and spine. This creates scar tissue, which makes it hard for your brain to send signals to these parts of your body.

Aubagio works differently from other medications for MS. It's the only pyrimidine synthesis inhibitor for treating MS.

How Aubagio exactly works isn't fully understood. It's thought that teriflunomide, the active drug in Aubagio, blocks a certain enzyme. Immune cells need this enzyme to quickly multiply. When the enzyme is blocked, the immune cells can't spread and attack the myelin.

How long does it take to work?

Aubagio starts to work right away after you take it. However, you may not notice a difference in your symptoms even after the drug starts working. That's because it works to help prevent relapses and new lesions, which are actions that may not be directly noticeable.

Taking Aubagio when you're pregnant may cause major birth defects. Don't take this drug if you're pregnant. If you might become pregnant and aren't using reliable birth control, you shouldn't take Aubagio.

If you do become pregnant while using Aubagio, stop taking the drug and tell your doctor right away. Also tell your doctor if you want to become pregnant within two years. In this case, they can start you on therapy to quickly remove Aubagio from your system (see 'Common questions about Aubagio' below).

Aubagio can stay in your blood for a long time, possibly up to two years after you stop treatment. The only way to know if Aubagio is still in your system is to do a blood test. Work with your doctor to have your levels tested to ensure that becoming pregnant is safe. Until you know that Aubagio is out of your system, it's important to keep using birth control.

You can also sign up for a registry that helps collect information about your experience. Pregnancy exposure registries help doctors learn more about how certain drugs affect women and their pregnancies. To sign up, call 800-745-4447 and press option 2.

If you're concerned about becoming pregnant while taking Aubagio, talk with your doctor. They can suggest effective methods of birth control.

For males: Males taking Aubagio should also use effective contraception. They should also let their doctor know if their partner plans on becoming pregnant.

It's not known whether Aubagio passes into breast milk.

Before taking Aubagio, tell your doctor if you're breastfeeding your child or plan to breastfeed. They can discuss with you the risks and benefits of taking the drug while breastfeeding.

Here are answers to some frequently asked questions about Aubagio.

Is Aubagio an immunosuppressant?

Aubagio is not classified as an immunosuppressant, but it may still weaken your immune system. If your immune system isn't strong enough to fight germs, you're more likely to get an infection.

If you're concerned about possible infections while taking Aubagio, talk with your doctor.

How do I do a 'washout' of Aubagio?

If you're taking Aubagio and become pregnant or want to become pregnant, tell your doctor right away. They can work to quickly remove Aubagio from your body.

Aubagio can remain in your system for up to two years after you stop taking it. To find out if you still have Aubagio in your system, you'll need to have a blood test.

For a 'washout,' or rapid elimination, of Aubagio, your doctor will give you either cholestyramine or activated charcoal powder.

Should I use birth control while taking Aubagio?

Yes, you should use contraception (birth control) while taking Aubagio.

If you're a female who can become pregnant, your doctor will give you a pregnancy test before you start Aubagio treatment. It's important that you don't become pregnant while taking Aubagio because the drug can cause birth defects.

Males taking Aubagio should also use effective contraception. They should also let their doctor know if their partner plans on becoming pregnant.

Does Aubagio cause flushing?

No. Studies of Aubagio didn't report flushing (warmth and redness in your skin) as a side effect of taking the drug.

However, flushing may be a side effect of other drugs that treat multiple sclerosis (MS), such as Tecfidera.

Will I have withdrawal effects if I stop taking Aubagio?

Withdrawal effects weren't reported in studies of Aubagio. So it isn't likely that you'll have withdrawal symptoms when you stop Aubagio treatment.

However, your multiple sclerosis (MS) symptoms may get worse when you stop taking Aubagio. That might seem like a withdrawal response, but it's not the same thing.

Don't stop taking Aubagio without talking to your doctor first. They can help you manage any worsening of your MS symptoms.

Can Aubagio cause cancer? Has it been associated with any deaths?

In clinical studies of Aubagio, cancer was not a side effect that occurred. However, in a case report, a woman with multiple sclerosis developed follicular lymphoma after taking Aubagio for eight months. The report did not claim that Aubagio was the cause of the cancer, but it didn't rule out that possibility.

In Aubagio clinical studies, four people died from heart problems. This was out of about 2,600 people taking the drug. But it wasn't shown that taking Aubagio caused these deaths.

This drug comes with several warnings.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

• Severe liver damage. Aubagio can cause severe liver problems, including liver failure. Taking Aubagio with other drugs that can affect your liver can increase the amount of Aubagio in your body. This can damage your liver. One of these drugs is Arava (leflunomide), which is prescribed to treat rheumatoid arthritis. Your doctor will give you blood tests before and while you take Aubagio to check your liver.
• Birth defects. If you're pregnant, you shouldn't take Aubagio because it may cause major birth defects. If you might become pregnant and aren't using reliable birth control, you shouldn't take Aubagio. If you become pregnant while taking Aubagio, stop taking it and tell your doctor right away.

Other warnings

Before taking Aubagio, talk with your doctor about your health history. Aubagio may not be right for you if you have certain medical conditions. These include:

• Liver disease. Aubagio can cause severe liver damage. If you have liver disease, Aubagio might make it worse.
• Previous allergic reactions. Avoid taking Aubagio if you've had an allergic reaction to:
  • teriflunomide
  • leflunomide
  • any other ingredients in Aubagio

There's limited information about using more than the recommended dosage of Aubagio.

What to do in case of overdose

If you think you've taken too much Aubagio, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if you think you're having a medical emergency, call 911 or go to the nearest emergency room right away.

When you get Aubagio from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Store Aubagio tablets at room temperature between 68°F and 77°F (20°C and 25°C).

Disposal

If you no longer need to take Aubagio and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indication

Aubagio is indicated to treat individuals with relapsing forms of multiple sclerosis (MS).

Mechanism of action

Aubagio contains the active ingredient teriflunomide. Teriflunomide inhibits a mitochondrial enzyme called dihydroorotate dehydrogenase, which is involved in de novo pyrimidine synthesis. Aubagio may also work by reducing the number of activated lymphocytes in the central nervous system.

Pharmacokinetics and metabolism

After oral administration, maximum concentration occurs within four hours. Aubagio primarily undergoes hydrolysis and is metabolized to minor metabolites. Secondary pathways of metabolism include conjugation, oxidation, and N-acetylation.

Aubagio is a CYP1A2 inducer and inhibits CYP2C8, efflux transporter breast cancer resistance protein (BCRP), OATP1B1, and OAT3.

Aubagio has a half-life of 18 to 19 days and is primarily excreted through feces (approximately 38%) and urine (approximately 23%).

Contraindications

Aubagio is contraindicated in patients who have:

• severe hepatic impairment
• a history of hypersensitivity to teriflunomide, leflunomide, or any other components of the drug
• concomitant use with leflunomide
• the potential for pregnancy without the use of contraceptives or are pregnant

Storage

Aubagio should be stored at room temperature between 68°F and 77°F (20°C and 25°C).

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.