Teriflunomide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat multiple sclerosis. Take it exactly as directed.
• Do not take this medicine if you are pregnant because it will seriously harm the baby.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: MS treatment

Generic and brand names: teriflunomide, oral; Aubagio

What is this medicine used for?

This medicine is taken by mouth to treat multiple sclerosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not take this medicine if you:

• Have severe liver problems
• Are of childbearing age and not using effective birth control
• Take a medicine called leflunomide

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergy to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• A bleeding or blood disorder such as anemia
• Breathing problems or lung disease
• Diabetes
• High blood pressure
• Kidney or liver disease
• Numbness or tingling in your hands or feet that is different from your MS symptoms
• You may need a TB skin test before you start treatment. Talk with your healthcare provider about this.

Tell your provider if you have any kind of infection or fever.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. You must use effective birth control while taking this medicine and until this medicine has been cleared from your body after your treatment ends. Talk with your healthcare provider about effective birth control. You must not get pregnant while you are using this medicine. If you think that you may be pregnant while taking this medicine or within 2 years after you stop taking it, contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: If you wish to father a child, stop taking this medicine. Talk with your healthcare provider about effective birth control. You must not father a child while you are using this medicine and until this medicine has been cleared from your body after your treatment ends.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

WARNING: Do not take this medicine if you are pregnant because it will seriously harm the baby. You will need to take a pregnancy test to be sure that you are not pregnant before taking this medicine. You must use a reliable method of birth control while taking this medicine. After you stop taking this medicine, do not become pregnant until you have completed a drug elimination procedure. Talk to your healthcare provider about this. After you start taking this medicine, if you have any sign of pregnancy such as a late period, stop taking this medicine and contact your healthcare provider right away. Do not breast-feed a baby while you are taking this medicine.

Severe liver injury is a rare, but serious side effect of this medicine. If you have itching, yellowing of your skin or eyes, severe stomach pain, dark urine, light-colored bowel movements, loss of appetite, unexplained nausea or vomiting, or unusual tiredness, contact your healthcare provider right away. These may be signs of severe liver injury.

This medicine may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine to help remove this medicine from your body more quickly. Talk with your provider about this.

You need to have blood tests and blood pressure checks regularly while taking this medicine. Keep all appointments for these tests.

Do not drink alcohol while taking this medicine. Alcohol can increase your risk of serious side effects.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines while you are taking this medicine and for 6 months after you stop taking this medicine without getting your healthcare provider's approval first.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes; dark colored urine; unexplained loss of appetite; severe stomach pain, nausea, or vomiting; unusual bruising or bleeding; unexplained tiredness or weakness; pale skin; chest pain; fast or irregular heartbeat; fever; sore throat; cough or shortness of breath; sores on the skin or in the mouth; numbness or tingling that is different from your MS symptoms; confusion; skin rash; itching, blistering or peeling skin; decreased urination.

Other: Hair loss, nausea, diarrhea, heartburn, weight loss, headache, dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alosetron (Lotronex)
• Antibiotics such as cefaclor, ciprofloxacin (Cipro), penicillin, and rifampin
• Antidepressants such as duloxetine (Cymbalta), fluvoxamine (Luvox), and mirtazapine (Remeron)
• Antipsychotic medicines such as asenapine (Saphris), clozapine (Clozaril, FazaClo), olanzapine (Zyprexa), pimozide (Orap), and trifluoperazine
• Bosentan (Tracleer)
• Cancer medicines such as enzalutamide (Xtandi), gefitinib (Iressa), paclitaxel (Abraxane, Taxol), pazopanib (Votrient), and topotecan (Hycamtin)
• Charcoal
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), ezetimibe (Zetia), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Diabetes medicines such as empagliflozin (Jardiance), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Eltrombopag (Promacta)
• Eluxadoline (Viberzi)
• Fingolimod (Gilenya)
• Furosemide (Lasix)
• Grazoprevir/elbasvir (Zepatier)
• Heart medicines such as amiodarone (Cordarone, Pacerone), mexiletine, olmesartan (Benicar), and valsartan (Diovan)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and mycophenolate (CellCept, Myfortic)
• Ketoprofen
• Leflunomide (Arava)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natalizumab (Tysabri)
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Selexipag (Uptravi)
• Theophylline
• Tizanidine (Zanaflex)
• Tofacitinib (Xeljanz)
• Tretinoin (Atralin, Renova, Retin-A)
• Vaccines
• Warfarin (Coumadin)
• Zidovudine (Retrovir)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.