INDICATIONS

ARAVA is indicated in adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as evidenced by X-ray erosions and joint space narrowing (see CLINICAL PHARMACOLOGY: CLINICAL STUDIES).

Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with ARAVA (see DRUG INTERACTIONS: NSAIDs). The combined use of ARAVA with antimalarials, intramuscular or oral gold, D penicillamine. azathioprine, or methotrexate has not been adequately studied (see WARNINGS: Immunosuppression Potential).

DOSAGE AND ADMINISTRATION

Loading Dose

Due to the long half-life in patients with RA and recommended dosing interval (24 hours), a loading dose is needed to provide steady-state concentrations more rapidly. It is recommended that ARAVA therapy be initiated with a loading dose of one 100 mg tablet per day for 3 days.

Maintenance Therapy

Daily dosing of 20 mg is recommended for treatment of patients with RA. A small cohort of patients (n=104), treated with 25 mg/day, experienced a greater incidence of side effects; alopecia, weight loss, liver enzyme elevations. Doses higher than 20 mg/day are not recommended. If dosing at 20 mg/day is not well tolerated clinically, the dose may be decreased to 10 mg daily. Liver enzymes should be monitored and dose adjustments may be necessary (see WARNINGS: Hepatotoxicity). Due to the prolonged half-life of the active metabolite of leflunomide, patients should be carefully observed after dose reduction, since it may take several weeks for metabolite levels to decline.

HOW SUPPLIED

ARAVA Tablets in 10 and 20 mg strengths are packaged in bottles ARAVA Tablets 100 mg strength are packaged in blister packs.

ARAVA™ (leflunomide) Tablets

Strength	Quantity	NDC Number	DESCRIPTION
10 mg	30 count bottle 100 count bottle	0088-2160-30 0088-2160-47	White round film-coated tablet embossed with ''ZBN'' on one side.
20 mg	30 count bottle 100 count bottle	0088-2161-30 0088-2161-47	Light yellow, triangular filmcoated tablet embossed with "7130'' on one side.
100 mg	3 count blister pack	0088-2162-30	White, round film-coated tablet embossed with ''ZBP'' on one side.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.

Rx only.