Teriflunomide may seriously or even fatally damage the liver, necessitating a liver transplant. People who already have liver disease and those taking other drugs that are known to cause liver damage are at an increased risk of developing liver damage. In case you have liver problems, let your doctor know. Your physician might advise against taking teriflunomide. Give your doctor and pharmacist a complete list of all the medications you take so they can determine whether any of them could make you more likely to experience liver damage while receiving treatment with teriflunomide. Call your doctor right away if you have any of the following symptoms: gastrointestinal discomfort in the upper right portion, vomiting, unusual bruising or bleeding, excessive exhaustion, lack of energy, appetite loss, yellowing of the skin or eyes, dark urine, or flu-like symptoms. Your doctor may suspend your treatment with teriflunomide and give you a medicine that will hasten the removal of teriflunomide from your body if liver damage is suspected.

Keep all of your appointments with your physician and the lab. Before you start therapy and periodically throughout it, your doctor will order certain tests to monitor how well your body is responding to teriflunomide.

If you are trying to get pregnant or are already pregnant, avoid taking teriflunomide. The foetus could suffer from teriflunomide. Teriflunomide shouldn’t be started until after a pregnancy test has come back negative and your doctor has confirmed that you are not pregnant. Until blood tests demonstrate that you have low enough levels of teriflunomide in your blood, you must use an efficient method of birth control before you start taking teriflunomide, throughout your treatment with teriflunomide, and for up to 2 years after treatment. During your teriflunomide treatment or for two years following your treatment, call your doctor right away if your period is irregular, you miss a period, or you suspect you could be pregnant. Both you and your spouse should use reliable birth control while you are receiving therapy if you are a man and they are capable of getting pregnant. Ask your doctor about a treatment that will hasten the removal of teriflunomide from your body after stopping the medicine if you or your partner intend to become pregnant or are capable of doing so.

You will get the manufacturer’s patient information sheet (Medication Guide) from your physician or pharmacist when you start taking teriflunomide and each time you refill your prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of taking teriflunomide with your doctor.

Teriflunomide comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take teriflunomide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take teriflunomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking teriflunomide,

• Tell your doctor and pharmacist if you are allergic to teriflunomide (rash, hives, shortness of breath, swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs), leflunomide (Arava), any other medications, or any of the ingredients in teriflunomide tablets. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Informing your physician that you are taking leflunomide (Arava). If you are currently on this medicine, your doctor generally won’t advise you to use teriflunomide.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: Alosetron (Lotronex), anticoagulants (also known as “blood thinners”) such warfarin (Coumadin, Jantoven), atorvastatin (Lipitor, in Caduet), cefaclor, cimetidine (Tagamet), ciprofloxacin (Cipro), duloxetine (Cymbalta), eltrombopag (Promacta), furosemide (Lasix); gefitinib (Iressa); ketoprofen; medications that can cause nerve damage such as medications for cancer, HIV, or AIDS; other medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus XR, Prograf); methotrexate (Otrexup, Rasuvo, Trexall); mitoxantrone; nateglinide (Starlix); oral contraceptives (birth control pills); paclitaxel (Abraxane, Taxol); penicillin G; pioglitazone (Actos, in Actoplus Met, in Duetact); pravastatin (Pravachol); repaglinide (Prandin, in Prandimet); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); rosiglitazone (Avandia); rosuvastatin (Crestor); simvastatin (Zocor, in Vytorin); theophylline (Elixophyllin, Theo-24, Uniphyl, others); tizanidine (Zanaflex); and zidovudine (Retrovir, in Combivir, in Trizivir). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with teriflunomide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor if you have diabetes, breathing issues, cancer or any other conditions that affect the bone marrow or immune system, high blood pressure, peripheral neuropathy (numbness, burning, or tingling in the hands or feet that feels different from your MS symptoms), kidney disease, or any other current or past infections, including persistent infections that do not go away.
• Inform your doctor if you are nursing a baby. Teriflunomide should not be taken while nursing a baby.
• Talk to your doctor about discontinuing teriflunomide and getting a procedure to hasten the drug’s removal from your body if you or your partner intends to get pregnant. During your teriflunomide therapy and for up to two years after treatment, if your partner does not intend to become pregnant, you and your partner should use an efficient method of birth control until blood tests indicate that you have sufficiently low levels of teriflunomide in your blood.
• You should let your doctor or dentist know if you are taking teriflunomide if you are having surgery, including dental surgery.
• Even though you may already have a deadly lung infection called tuberculosis (TB), you could not yet be showing any signs of the illness. Inform your doctor if you currently have or previously had TB, if you’ve lived in or travelled to a country where TB is prevalent, or if you’ve come into contact with somebody who has. Your doctor will do a skin test to determine whether you have TB before you start your teriflunomide medication. Before you start taking
• While you are taking teriflunomide and for six months after you stop taking it, avoid getting any immunizations without first consulting your doctor.
• Teriflunomide may produce high blood pressure, so you should be aware of it. Before commencing treatment and on a frequent basis going forward, get your blood pressure tested.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Teriflunomide might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Hair fall
• Diarrhea
• Hazy vision
• Toothache
• Acne
• Itching
• Muscle or joint pain
• Anxiety
• Loss of weight

Some adverse effects can be very harmful. Call your doctor right away if you have any of these symptoms or any of those detailed in the IMPORTANT WARNING section and stop taking teriflunomide:

• A rapid, erratic, or slow heartbeat
• Headache
• Dizziness
• Pale skin
• Confusion
• Other symptoms of infection include chills, a fever, a cough, and sore throat
• Hands, arms, feet, or legs that are numb, burning, or tingly
• Muscle tone loss
• Leg heaviness or weakness
• Grey, cold skin
• Skin that is red, peeling, or blistered
• Rash
• Hives
• Itching
• Having trouble swallowing
• Swelling of the lips, face, throat, eyes, mouth, or tongue
• Breathing difficulty
• Rash that could accompany a fever, swollen glands, or facial swelling
• Back, side, or stomach pain

Other negative effects of teriflunomide are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.