RVP

Drug Catalog - Product Detail

LEFLUNOMIDE TB 10MG 30

NDC Mfr Size Str Form
00955-1735-30 WINTHROP, US 30 10MG TABLET
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PACKAGE FILES

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Generic Name
LEFLUNOMIDE
Substance Name
LEFLUNOMIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA020905
Description
11 DESCRIPTION Leflunomide is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C 12 H 9 F 3 N 2 O 2 , a molecular weight of 270.2 and the following structural formula: Leflunomide is available for oral administration as tablets containing 10 or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, talc, titanium dioxide, and yellow ferric oxide (20 mg tablet only). Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Leflunomide Tablets Strength Quantity NDC Number Description 10 mg 30 count bottle 0955-1735-30 White, round film-coated tablet embossed with "ZBN" on one side. 20 mg 30 count bottle 0955-1737-30 Light yellow, triangular film-coated tablet embossed with "ZBO" on one side. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Leflunomide is indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Loading dosage for patients at low risk for leflunomide-associated hepatotoxicity and leflunomide-associated myelosuppression: 100 mg daily for 3 days. ( 2.1 ) Maintenance dosage: 20 mg daily. ( 2.1 ) Maximum recommended daily dosage: 20 mg once daily. ( 2.1 ) If 20 mg once daily is not tolerated, may decrease dosage to 10 mg once daily. ( 2.1 ) Screen patients for active and latent tuberculosis, pregnancy test (females), blood pressure, and laboratory tests before starting leflunomide. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of leflunomide is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of leflunomide-associated hepatotoxicity and leflunomide-associated myelosuppression. The loading dose provides steady-state concentrations more rapidly. For patients who are at low risk for leflunomide-associated hepatotoxicity and leflunomide-associated myelosuppression, the recommended leflunomide loading dose is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily. For patients at high risk for leflunomide-associated hepatotoxicity (e.g., those taking concomitant methotrexate) or leflunomide-associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended leflunomide dosage is 20 mg once daily without a loading dose [see Warnings and Precautions (5.2 , 5.4) ]. The maximum recommended daily dose is 20 mg once per day. Consider dosage reduction to 10 mg once daily for patients who are not able to tolerate 20 mg daily (i.e., for patients who experience any adverse events listed in Table 1). Monitor patients carefully after dosage reduction and after stopping therapy with leflunomide, since the active metabolite of leflunomide, teriflunomide, is slowly eliminated from the plasma [see Clinical Pharmacology (12.3) ] . After stopping leflunomide treatment, an accelerated drug elimination procedure is recommended to reduce the plasma concentrations of the active metabolite, teriflunomide [see Warnings and Precautions (5.3) ] . Without use of an accelerated drug elimination procedure, it may take up to 2 years to reach undetectable plasma teriflunomide concentrations after stopping leflunomide [see Clinical Pharmacology (12.3) ] . 2.2 Evaluation and Testing Prior to Starting Leflunomide Prior to starting leflunomide treatment, the following evaluations and tests are recommended: Evaluate patients for active tuberculosis and screen patients for latent tuberculosis infection [see Warnings and Precautions (5.4) ] Laboratory tests including serum alanine aminotransferase (ALT); and white blood cell, hemoglobin or hematocrit, and platelet counts [see Warnings and Precautions (5.2 , 5.4) ] For females of reproductive potential, pregnancy testing [see Warnings and Precautions (5.1) ] Check blood pressure [see Warnings and Precautions (5.10) ]