Generic Arava ™ ®: Leflunomide
Leflunomide is the chemical name of the active ingredient in Arava ™ ®

Tablets
Chemical Name: LEFLUNOMIDE (le-FLUN-o-mide)

Common uses : This medicine is a pyrimidine synthesis inhibitor used to treat rheumatoid arthritis. This medicine may be used to reduce the signs and symptoms of rheumatoid arthritis, slow the development of damage to the joints, and to improve physical function.

Before using : WARNING: This medicine can cause harm to the human fetus. For this reason a negative pregnancy test must be obtained before the start of treatment with leflunomide. This medicine must not be used during pregnancy, or by women who are able to become pregnant unless they are using a reliable form of birth control. Unless females who have taken leflunomide go through a certain process to remove this medicine from their body, pregnancy must be avoided for at least 2 years after this medicine has been stopped. Discuss the risks and the benefits of taking this medicine with your doctor. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking cholestyramine. DO NOT RECEIVE LIVE VACCINES WHILE YOU ARE TAKING THIS MEDICINE. Contact your doctor for more information. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other medicines that suppress the immune system. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of blood, bone marrow, or immune system disorders; liver disease; hepatitis B or C infection; or serious, uncontrolled infections. Use of this medicine in children under age 18 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

Directions : Follow the directions for using this medicine provided by your doctor. THIS MEDICINE CAN REMAIN IN THE BODY FOR UP TO 2 YEARS after you stop taking it. If your doctor decides that you are required to stop taking this medicine, a process exists that may help to remove the medicine from your body faster. Ask your doctor or pharmacist for more information. STORE THIS MEDICINE at room temperature below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.

Cautions : DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. It may take 4 weeks or more to notice any improvement while taking this medicine. DO NOT STOP USING THIS MEDICINE without first checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. Laboratory and/or medical tests such as complete blood counts may be done to monitor your progress or to check for side effects. This medicine rarely has caused serious liver problems, sometimes resulting in death. Problems usually occurred within the first 6 months of treatment and usually in patients with other conditions or taking other medicines that increased their risk for liver problems. CONTACT YOUR DOCTOR IMMEDIATELY if you experience any sign of liver problems including yellow eyes or skin, dark urine, or stomach pain, especially if you also have a fever. Liver function tests should be done before you start taking this medicine and regularly while you are taking this medicine to monitor for liver problems. Alcohol also increases your risk for liver problems. Talk with your doctor before drinking alcohol while taking this medicine. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. CHECK WITH YOUR DOCTOR BEFORE HAVING IMMUNIZATIONS (VACCINATIONS) for up to 2 years after stopping this medicine. If you develop a serious infection, your therapy may need to be stopped and you may need to complete the elimination procedure. Contact your doctor immediately if you experience any sign of infection including fever, usual tiredness, or sore throat. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR MEN: this medicine may cause birth defects in children of men taking this medicine at the time of conception. Talk with your doctor or pharmacist about the use of effective birth control such as condoms while taking this medicine. IF YOU PLAN ON FATHERING A CHILD, talk with your doctor to discuss your treatment plan. FOR WOMEN: THIS MEDICINE CAN CAUSE SEVERE BIRTH DEFECTS. DO NOT USE THIS MEDICINE if you are pregnant. You must have a negative pregnancy test before starting this medicine. Use a reliable form of birth control while taking this medicine and for 2 years after stopping this medicine. Ask your doctor or pharmacist if you have any questions about effective birth control options. IF YOU SUSPECT THAT YOU COULD BE PREGNANT or if your period is late, contact your doctor immediately. If you plan on becoming pregnant within 2 years of stopping this medicine, you may also need to follow the elimination procedure. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.

Possible side effects : SIDE EFFECTS that may occur while taking this medicine include nausea, diarrhea, headache, pain, back pain, muscle aches, runny or stuffy nose, weight loss, or hair loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain, blistering or peeling skin; skin rash; sores or blisters on the inside of eyes, nose, or mouth; fever, sore throat or any other sign of infection; feelings of numbness or tingling; pale skin; yellowing of skin or eyes; dark urine; pale stools; unusual tiredness; muscle cramps including leg cramps; vomiting; or easy bruising or bleeding. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions : Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions

If you take too much : If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional information : DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. KEEP THIS PRODUCT out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.