Rheumatoid arthritis

Indication for Leflunomide

Population group: Suitable for both men and women, only adults (18 years old or older)

Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a “disease-modifying antirheumatic drug” (DMARD).

Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.

Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

For this indication, competent medicine agencies globally authorize below treatments:

10-100 mg once daily

Route of admnistration


Defined daily dose

10 - 100 mg

Dosage regimen

From 10 To 100 mg once every day

Loading dose

100 mg

Detailed description

Leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days. Omission of the loading dose may decrease the risk of adverse events.

The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.

Active ingredient

Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties. A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.

Read more about Leflunomide

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