Leflunomide (Oral Route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of leflunomide in the elderly. However, elderly patients are more likely to have age-related nerve problems, which may require caution in patients receiving leflunomide.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems, history of or
• Bone marrow dysplasia or
• Immune system problem or
• Infection, severe or uncontrolled or
• Tuberculosis, history of or
• Weak immune system—Use is not recommended in patients with these conditions.

• Diabetes or
• Nerve problems—May increase your risk for more serious side effects.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not be used in patients with these condition.

• Lung disease (eg, interstitial lung disease), history of—Use with caution. May make this condition worse.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For rheumatoid arthritis:
    • Adults—
      • For patients who are at low-risk for liver disease and bone marrow problems caused by Arava®: At first, 100 milligrams (mg) once a day for 3 days, then 20 mg once a day. Your doctor may adjust the dose as needed. Your doctor may adjust your dose as needed and tolerated.
      • For patients who are at high-risk for liver disease and bone marrow problems caused by Arava®: 20 mg once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.