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Indications - Leflunomide is indicated in adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as manifested by x-ray erosions and joint space narrowing.

Dosage & Administration - Leflunomide once-daily oral dosing for rheumatoid arthritis patients. After a loading dose of 100 mg once daily for 3 days, the maintenance dose is 20 mg once daily. Leflunomide does not require step wise dose increment over time. The dose may be decreased to 10 mg daily if tolerability issues arise.

Side Effects - Adverse reactions associated with the use of leflunomide include diarrhea, nausea, vomiting, abdominal pain, headache, respiratory infection, bronchitis, elevated liver enzymes, aggravation of pre-existing hypertension, alopecia, and rash.

Contraindications - Leflunomide is contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide, hepatic impairment, severe uncontrolled infections and bone marrow dysplasia.

Others - Pregnancy & Lactation: Leflunomide is not recommended for pregnant women. Pregnancy must be avoided during leflunomide treatment or prior to the completion of the drug elimination procedure after leflunomide treatment. Leflunomide should not be used by nursing mothers. It is not known whether leflunomide is excreted in human milk. Many drugs are excreted in human milk and there is a potential for serious adverse reactions in nursing infants from leflunomide. Therefore, a decision should be made whether to proceed with nursing or initiate treatment with leflunomide, taking into account the importance of the drug to the mother.