When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to leflunomide, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using teriflunomide.
• Some medicines can affect how leflunomide works. Tell your doctor if you are using any of the following:
  
  • Alosetron, cefaclor, cimetidine, ciprofloxacin, duloxetine, furosemide, ketoprofen, methotrexate, mitoxantrone, paclitaxel, penicillin G, pioglitazone, rifampin, rosiglitazone, theophylline, tizanidine, warfarin, zidovudine
  • Birth control pills
  • Medicines that weaken your immune system, including a steroid or cancer medicines
  • Statin medicine (including atorvastatin, nateglinide, pravastatin, repaglinide, simvastatin)
• Ask your doctor before you get a flu shot or any other vaccines. You should not receive live virus vaccines while you are taking this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have kidney disease, liver disease, diabetes, any infection, lung disease, or a history of tuberculosis or blood or bone marrow problems.
• This medicine may cause the following problems:
  
  • Liver problems
  • Serious skin reactions, including drug reaction with eosinophilia and systemic reaction which can cause organ damage
  • Possible increased risk of cancer
  • Nerve problems
  • Lung problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor will also check your blood pressure.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Chest pain or discomfort, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow eyes or skin
• Fever, chills, cough, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Hair loss

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088