leflunomide – oral, Arava
WARNING: Leflunomide must not be used during pregnancy because it may cause serious harm to an unborn baby. Women of childbearing age must have a negative pregnancy test before starting this medication. They must also use reliable forms of birth control before starting leflunomide, while taking it, and after stopping it until they have finished taking another drug that helps leflunomide leave the body and confirmed through 2 blood tests that the leflunomide levels are very low. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug may rarely cause serious liver disease. Most cases occur within 6 months of taking this drug. If you already have liver disease (such as hepatitis B or C), leflunomide should not be used. Liver function tests must be performed periodically while taking leflunomide. Tell your doctor immediately if you notice dark urine, persistent nausea/vomiting, light-colored stools, stomach/abdominal pain, yellowing eyes/skin. See Drug Interactions section.
USES: This medication is used to treat rheumatoid arthritis, a condition in which the body’s defense system fails to recognize the body as itself and attacks the healthy tissues around the joints. Leflunomide helps to reduce the joint damage/pain/swelling and helps you to move better. It works by weakening your immune system and decreasing inflammation.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your healthcare professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your healthcare professional.This drug may also be used to prevent rejection of organ transplant.
HOW TO USE: Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Take this medication exactly as prescribed. You may be instructed to take a higher dose for the first 3 days of treatment. Dosage is based on your medical condition and response to therapy. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. After treatment is stopped, a different drug (cholestyramine) may be given as directed to help remove leflunomide from your body. Consult your doctor or pharmacist for more details. Inform your doctor if your symptoms persist or worsen.
SIDE EFFECTS: Diarrhea, nausea, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: cough, numbness/tingling of hands/feet, hair loss, chest pain, fast/pounding heartbeat, increased thirst/urination, muscle cramp/pain, mental/mood changes, vision changes. Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, unusual growths/lumps, swollen glands, unexplained weight loss, unusual tiredness. Leflunomide may increase blood pressure. Your blood pressure should be checked regularly while you are taking this medication. This medication can lower the body’s ability to fight an infection. Tell your doctor immediately if you develop any signs of an infection such as fever, chills, or persistent sore throat. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling, severe dizziness, trouble breathing. Leflunomide can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada.
PRECAUTIONS: Before taking leflunomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system disorder, current/recent infection, cancer, bone marrow/blood disorder, kidney disease, liver disease, alcohol abuse, heart disease, high blood pressure, lung disease. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they can make you dizzy and also cause liver disease. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others. This medication must not be used during pregnancy. It may harm an unborn baby. Before starting this medication, women of childbearing age must have a negative pregnancy test before starting this medication. Men and women must use effective forms of birth control while taking this medication. Consult your doctor for more details and to discuss reliable forms of birth control. It is not known whether this medication affects the sperm. To minimize any possible risk, the manufacturer recommends that men wishing to father a child should consider stopping the medication and using another drug as directed to help this drug leave the body before attempting to father a child. Consult your doctor for more details. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use Section. Drug interactions may change how your medications work or increase your risk for serious side effects. Keep a list of all the products you use and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: warfarin, rifamycins, drugs affecting the liver, cholestyramine, other drugs that weaken the immune system. Because teriflunomide is very similar to this medication, do not take it while you are taking leflunomide.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others. A skin test to check for tuberculosis should be performed before you start this medication. While taking this medication, laboratory and/or medical tests should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Brief storage between 59-86 degrees F is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088. Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
