Leflunomide

【Indications】

This product is indicated for adult rheumatoid arthritis, serving to improve disease progression. It is also indicated for the treatment of lupus nephritis.

【Recommended Dosage】

(1) Adult Rheumatoid Arthritis:

Oral administration. Due to the long half-life of Leflunomide, dosing should be spaced 24 hours apart. To rapidly achieve steady-state plasma concentration, a loading dose of 50 mg once daily is recommended for the first three days, followed by a maintenance dose of 10 mg or 20 mg once daily based on the patient's condition. Nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose corticosteroids may be continued during treatment.

(2) Lupus Nephritis:

Oral administration. The recommended dose is 20-40 mg once daily, adjusted according to the disease status. The dosage may be appropriately reduced after remission. It can be used in combination with glucocorticoids, or strictly as directed by a physician.

【Adverse Reactions】

The most frequently reported adverse reactions include: mild elevation of blood pressure, leukopenia, paresthesia, headache, dizziness, diarrhea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, oral ulcers), abdominal pain, increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin, tenosynovitis, increased CPK (creatine phosphokinase), anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions, and elevated liver parameters [transaminases (especially alanine aminotransferase ALT), γ-glutamyl transpeptidase (γ-GT), alkaline phosphatase, and less commonly, bilirubin].

【Pharmacological Action】

Leflunomide is an isoxazole-class immunosuppressant with antiproliferative activity. It primarily inhibits dihydroorotate dehydrogenase activity, thereby interfering with pyrimidine synthesis in activated lymphocytes. Some in vivo and in vitro studies indicate that this product possesses anti-inflammatory properties.

【Storage】

Protect from light, store in a sealed container in a dry place.