Pronunciation:

ter-i-FLOO-noe-mide

Brand Names:

• Aubagio

Dosage Forms:

• Tablet

Warnings:

HepatotoxicityClinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting. Concomitant use of teriflunomide with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide and monitor ALT levels at least monthly for six months. If drug induced liver injury is suspected, discontinue teriflunomide and start accelerated elimination procedure.Embryofetal ToxicityTeratogenicity and embryolethality occurred in animals administered teriflunomide. Exclude pregnancy prior to initiating teriflunomide therapy. Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure. Stop teriflunomide and use an accelerated drug elimination procedure if the patient becomes pregnant .

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Dihydroorotate Dehydrogenase Inhibitor

Uses of This Medicine:

Teriflunomide is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of teriflunomide in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of teriflunomide in patients over the age of 65 years. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Leflunomide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acyclovir
• Adenovirus Vaccine
• Alpelisib
• Amiodarone
• Asciminib
• Atorvastatin
• Baricitinib
• Bosentan
• Cefaclor
• Ciprofloxacin
• Dabrafenib
• Daprodustat
• Dasabuvir
• Dengue Tetravalent Vaccine, Live
• Elagolix
• Eltrombopag
• Enzalutamide
• Furosemide
• Glyburide
• Grazoprevir
• Influenza Virus Vaccine, Live
• Irinotecan
• Letermovir
• Measles Virus Vaccine, Live
• Methotrexate
• Momelotinib
• Montelukast
• Mumps Virus Vaccine, Live
• Paclitaxel
• Pitavastatin
• Poliovirus Vaccine, Live
• Repaglinide
• Revefenacin
• Rosuvastatin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Selexipag
• Simvastatin
• Smallpox Vaccine
• Sulfasalazine
• Tenofovir Alafenamide
• Topotecan
• Tucatinib
• Valacyclovir
• Varicella Virus Vaccine, Live
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems or
• Carpal tunnel syndrome or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure) or
• Liver disease or
• Lung disease (eg, acute interstitial pneumonitis, interstitial lung disease) or
• Peripheral neuropathy (nerve problem) or
• Tuberculosis, history of or
• Weak immune system—Use with caution. May make these conditions worse.

• Diabetes—May increase risk of having nerve problems.

• Infection, active—Should be treated first before starting this medicine.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not suddenly stop using it, do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this with or without food.

Teriflunomide may stay in your blood for up to 2 years after your treatment. Your doctor may want you to use activated charcoal or cholestyramine (Questran®) to help remove this medicine from the body much faster if necessary. Talk to your doctor if you have questions about this.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For multiple sclerosis:
    • Adults—7 or 14 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women will receive a pregnancy test before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and after 2 years of stopping treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Teriflunomide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men taking teriflunomide should use condoms as a form of birth control during sexual intercourse. A man intending to father a child should stop taking this medicine and check with his doctor right away.

Do not use this medicine together with leflunomide (Arava®). Using these medicines together may cause serious unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Teriflunomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

While you are being treated with teriflunomide, for at least 6 months you stop using it, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccines should not be given while receiving this medicine.

Using this medicine may increase your risk of getting cancers, including blood cancer. Talk to your doctor if you have concerns about this risk.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, trouble breathing, trouble swallowing, fever or chills.

This medicine may cause serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have a black, tarry stools, blistering, peeling or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Tell your doctor right away if you or your child develop a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin after using this medicine. These may be symptoms of a serious and life-threatening condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

Check with your doctor right away if you have a cough with or without a fever or trouble breathing while taking this medicine.

You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

cough

cough producing mucus

diarrhea

difficulty breathing

ear congestion

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

loss of voice

muscle aches and pains

nausea

runny or stuffy nose

shivering

sneezing

sore throat

sweating

tightness in the chest

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Agitation

black, tarry stools

bloody or cloudy urine

blurred vision

burning, numbness, pain, or tingling in all fingers except smallest finger

clay colored stools

coma

confusion

dark urine

decreased appetite

decreased urine output

depression

diarrhea

difficult, burning, or painful urination

dizziness

fast, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

hostility

irritability

itching or skin rash

lethargy

loss of appetite

lower back or side pain

muscle twitching

pale skin

pounding in the ears

rapid weight gain

seizures

slow or fast heartbeat

stomach pain or tenderness

stupor

swelling of the feet or lower legs

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

weakness or heaviness of the legs

yellow eyes or skin

Rare

Blistering, peeling, or loosening of the skin

joint pain

red skin lesions, often with a purple center

red, irritated eyes

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Hair loss or thinning of the hair

Less common

Blemishes on the skin

bone pain

burning, dry, or itching eyes

difficulty with moving

discharge or excessive tearing

full or bloated feeling

muscle cramping or stiffness

pain in the lower back, bottom, or hips

pain in the upper leg

pimples

pressure in the stomach

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swelling of the stomach area

swollen joints

toothache

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.