How does this medication work? What will it do for me?

Teriflunomide belongs to the class of medications called immunomodulators. This medication is used to treat adults with relapsing remitting multiple sclerosis (RRMS).

Multiple sclerosis (MS) is believed to be an autoimmune disorder, meaning it occurs because the person's immune system attacks their own tissues. In the case of MS, the immune system sees the protective covering on the nerves and attacks it. Teriflunomide works by changing how the body's immune system works, reducing the number of MS flare-ups and delaying physical disability because of the disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each pale blue to pastel blue, pentagonal, film-coated tablet, with dose strength imprint on one side given as number 14 and engraved with corporate logo on the other side, contains teriflunomide 14 mg. Nonmedicinal ingredients: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. Film coating: hypromellose, titanium dioxide, talc, polyethylene glycol, and indigo carmine aluminum lake.

How should I use this medication?

The recommended adult dose is 14 mg taken once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

Teriflunomide may be taken with food or on an empty stomach.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Discard any tablets remaining in the bottle 90 days after opening.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take teriflunomide if you:

  • are allergic to teriflunomide or any ingredients of the medication
  • are allergic to leflunomide
  • are currently taking leflunomide
  • have severely reduced liver function
  • are pregnant or may become pregnant, unless you use reliable birth control
  • have an immunodeficiency condition (e.g., AIDS, transplant recipients taking medications that suppress the immune system)
  • have an impaired bone marrow function or other blood disorders due to causes other than rheumatoid arthritis
  • have serious active infections

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • cold sores
  • diarrhea
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • hair loss
  • muscle aches
  • nausea
  • toothache
  • upset stomach
  • weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • frequent urination
  • numbness or tingling of hands and feet
  • prolonged menstrual bleeding (e.g., longer than 7 days)
  • rash
  • shortness of breath
  • signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of lung inflammation (interstitial lung disease; shortness of breath, difficulty breathing, cough)
  • symptoms of colitis (inflammation in the bowel; abdominal pain, bloody diarrhea, cramping, weight loss, fatigue)
  • symptoms of high blood pressure (e.g., headache, vision changes, nausea, vomiting)
  • symptoms of psoriasis (e.g., dry cracked skin, red patches of skin covered with silvery scales, sore, swollen, or stiff joints)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Birth defects: Medications similar to teriflunomide can cause major birth defects in children whose fathers or mothers were using it at the time of conception. For men or women taking teriflunomide, pregnancy must be avoided during and for up to two years after you stop taking teriflunomide. Talk to your doctor about when it is safe to get pregnant or father a child.

If either partner is taking teriflunomide, a reliable method of birth control should always be used throughout the course of treatment with teriflunomide.

Blood counts: In addition to decreasing the number of neutrophils (a type of white blood cell that helps fight infection), teriflunomide may cause decreased numbers of red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, or unexpected fatigue and weakness, contact your doctor immediately.

Galactose intolerance/glucose malabsorption: Teriflunomide is prepared with lactose. If you have lactose or galactose intolerance you should not take this medication.

Hypersensitivity reactions: In rare cases, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) may occur. This reaction involves symptoms including fever, swollen glands, yellowing of the skin or eyes, flu-like symptoms with skin rash or blistering, or other symptoms affecting the organs. Get immediate medical attention if you have symptoms of a severe allergic reaction. If you experience any unusual symptoms, contact your doctor.

Infection: Teriflunomide works on the immune system to help reduce the damage that parts of the immune system cause to the body. It can reduce the number of cells that fight infection in the body (white blood cells). As a result, teriflunomide may reduce the body's ability to fight severe infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do regular blood tests to monitor the number of specific types of blood cells in your blood.

Liver function: Teriflunomide can cause severe damage to the liver, including fatal liver failure. People with reduced liver function or liver disease may be more likely to experience additional liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Lung inflammation: Rarely, some people taking teriflunomide have experienced lung inflammation (interstitial lung disease), causing difficulty breathing. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking teriflunomide, contact your doctor immediately.

Pancreatitis: Teriflunomide can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Vaccines: Live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella) should not be given when you are taking teriflunomide.

Pregnancy: This medication is likely to cause serious harm and birth defects to the unborn baby if it is taken by a pregnant mother. It is important that teriflunomide is not used during pregnancy or by women who may become pregnant. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if teriflunomide passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors who use teriflunomide may be more likely to experience side effects. Discuss with your doctor whether this medication is right for you.

What other drugs could interact with this medication?

There may be an interaction between teriflunomide and any of the following:

  • activated charcoal
  • alcohol
  • bacillus Calmette-Guérin (BCG)
  • baricitinib
  • birth control pills
  • bosentan
  • caffeine and caffeine-containing products
  • cholestyramine
  • cimetidine
  • ciprofloxacin
  • cladribine
  • clofarabine
  • clomipramine
  • clozapine
  • colesevelam
  • colestipol
  • denosumab
  • desloratadine
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide)
  • duloxetine
  • echinacea
  • elagolix
  • eluxadoline
  • empagliflozin
  • enzalutamide
  • ezetimibe
  • estrogens (estradiol, conjugated/equine, esterified, estropipate)
  • fexofenadine
  • fingolimod
  • hepatitis C antivirals (e.g., glecaprevir and pibrentasvir, grazoprevir, voxilaprevir)
  • irinotecan
  • leflunomide
  • lidocaine
  • melatonin
  • methotrexate
  • mexiletine
  • mycophenolate
  • natalizumab
  • non-steroidal anti-inflammatory drugs (NSAIDs; diclofenac, ibuprofen, ketorolac, naproxen)
  • ocrelizumab
  • olanzapine
  • olmesartan
  • ozanimod
  • paclitaxel
  • penicillin
  • pimecrolimus
  • pioglitazone
  • pirfenidone
  • pomalidomide
  • propranolol
  • protein kinase inhibitors (e.g., dabrafenib, erlotinib, gefitinib, pazopanib, tofacitinib)
  • rasagiline
  • repaglinide
  • rifampin
  • riluzole
  • roflumilast
  • ropinirole
  • siponimod
  • "statin" cholesterol mediations (e.g., atorvastatin, fluvastatin, pravastatin, rosuvastatin)
  • sulfasalazine
  • tacrolimus
  • theophyllines (e.g., aminophylline, theophylline)
  • tizanidine
  • topotecan
  • trastuzumab
  • vaccines
  • valsartan
  • warfarin
  • zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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