TERIFLUNOMIDE

(ter i FLOO noe mide) Brand: Aubagio

What is the most significant information I must know about teriflunomide?

• Teriflunomide is used to reduce flare-ups in people with relapsing multiple sclerosis (MS). Teriflunomide is not a cure for MS.

• You must not use this medication if you have severe liver malady, or if you are also taking leflunomide (Arava).

• Teriflunomide can harm an unborn child or reason birth defects. Do not use teriflunomide if you are pregnant. Speak your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

• Use birth control to prevent pregnancy while you are using teriflunomide, whether you are a man or a woman. Teriflunomide use by either parent may reason birth defects.

• Teriflunomide can lower blood cells that help your body fight infections. This can create it easier for you to get sick from being near others who are ill. While using teriflunomide, you may need blood trials each 6 months. Your blood pressure will also need to be checked often.

• After you stop taking teriflunomide, the drug could remain in your body for up to 2 years. You may need to be treated with another medications to help your body eliminate teriflunomide quickly. Follow your doctor's instructions.

What is teriflunomide?

• Teriflunomide affects the immune system and reduces swelling and inflammation in the nervous system.

• Teriflunomide is used to reduce flare-ups in people with relapsing multiple sclerosis (MS). Teriflunomide is not a cure for MS.

• Teriflunomide may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking teriflunomide?

• Your doctor may need to test your liver function up to 6 months till you start taking teriflunomide. While using teriflunomide, you may need frequent blood trials at your doctor's office.

• You must not use this medication if you are allergic to teriflunomide , if you have severe liver malady, or if you are also taking leflunomide (Arava).

• To create certain teriflunomide is safety for you, speak your doctor if you have:

· tall blood pressure;

· liver disease;

· kidney disease;

· diabetes;

· breathing problems;

· tall levels of potassium in your blood; or

· if you have ever had serious skin problems caused by taking medicine.

• Till you start treatment with teriflunomide, your doctor may perform trials to create certain you do not have tuberculosis or another infections.

• FDA pregnancy category X. This medicine can reason birth defects. Do not use teriflunomide if you are pregnant. Your doctor may want you to have a pregnancy test to create certain you are not pregnant till you start taking teriflunomide.

• Stop taking teriflunomide if you miss a period or think you might be pregnant. Speak your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends. If you get pregnant while taking teriflunomide, you will need to receive medications to help your body eliminate the drug quickly, to lower the risk of harm to your unborn child. You may also need to go through this drug elimination procedure if you get pregnant within 2 years after you stop taking teriflunomide.

• Use birth control to prevent pregnancy while you are taking teriflunomide. After you stop taking teriflunomide, continue using birth control before you have received blood trials to create certain the drug has been eliminated from your body.

• If a man fathers a baby during or after teriflunomide treatment, the child may have birth defects. Use a condom to prevent pregnancy while you are taking teriflunomide. After your treatment ends, continue using condoms before you have received the medications to help your body eliminate teriflunomide, or before you have received blood trials to create certain the drug has been eliminated from your body.

• It is not known whether teriflunomide passes into breast milk or if it could harm a nursing child. You must not breast-feed while using this medicine.

How must I take teriflunomide?

• Teriflunomide is generally taken once for day. Follow all directions on your prescription label. Do not take this medication in larger or less amounts or for longer than recommended.

• You may take teriflunomide with or without food.

• Teriflunomide can lower blood cells that help your body fight infections. This can create it easier for you to get sick from being near others who are ill.

• While using teriflunomide, you may need blood trials each 6 months. Your blood pressure will also need to be checked often.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking teriflunomide?

• Do not receive a "live" vaccine while using teriflunomide, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from malady. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of teriflunomide?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Stop using teriflunomide and call your doctor at once if you have:

· fever, chills, body aches, flu symptoms, sores in your mouth and throat;

· nausea, upper stomach pain, itching, weary feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· quick or racing heartbeats;

· numbness or tingling in your hands or foots that feels various from your regular MS symptoms;

· pain in your side or lower back, confusion, few or no urinating;

· chest pain, dry cough, wheezing, feeling short of breath;

· skin redness or peeling;

· swelling, rapid weight gain; or

· severe skin reaction -- fever, sore throat, swelling in your person or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the person or upper body) and causes blistering and peeling.

• General side effects may include:

· diarrhea;

· thinning hair; or

· burning or prickly feeling in your skin.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect teriflunomide?

• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with teriflunomide, especially:

· acetaminophen (Tylenol);

· alosetron;

· duloxetine;

· melatonin;

· methotrexate;

· ramelteon;

· paclitaxel;

· pioglitazone, rosiglitazone;

· repaglinide;

· tacrine;

· theophylline;

· tizanidine;

· warfarin, Coumadin;

· an antibiotic, antifungal medication, sulfa drug, or tuberculosis medicine;

· birth control pills or hormone replacement therapy;

· cholesterol-lowering medications--Crestor, Lipitor, Pravachol, Simcor, Vytorin, Zocor, and others;

· gout or arthritis medications (including gold injections);

· HIV or AIDS medications;

· medication to treat mental illness;

· an NSAID (non-steroidal anti-inflammatory drug)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, others;

· seizure medication--carbamazepine, phenytoin, and others; or

· steroids (prednisone and others).

• This list is not complete. Another drugs may interact with teriflunomide, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your pharmacist can provide more information about teriflunomide.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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