Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)
NorthStar RxLLC
LEFLUNOMIDE
LEFLUNOMIDE 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
LEFLUNOMIDE - LEFLUNOMIDE TABLET NORTHSTAR RXLLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEFLUNOMIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEFLUNOMIDE TABLETS. LEFLUNOMIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: EMBRYO-FETAL TOXICITY AND HEPATOTOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ EMBRYO-FETAL TOXICITY · TERATOGENICITY AND EMBRYO-LETHALITY OCCURRED IN ANIMALS ADMINISTERED LEFLUNOMIDE. (5.1, 8.1) · EXCLUDE PREGNANCY PRIOR TO INITIATING LEFLUNOMIDE THERAPY. (5.1, 8.3) · ADVISE USE OF EFFECTIVE CONTRACEPTION IN FEMALES OF REPRODUCTIVE POTENTIAL DURING TREATMENT AND DURING A DRUG ELIMINATION PROCEDURE. (5.1, 5.3, 8.3) · STOP LEFLUNOMIDE AND USE AN ACCELERATED DRUG ELIMINATION PROCEDURE IF THE PATIENT BECOMES PREGNANT. (5.1, 5.3, 8.1) HE PATO TO XIC ITY · SEVERE LIVER INJURY AND FATAL LIVER FAILURE HAVE BEEN REPORTED. (5.2) · AVOID LEFLUNOMIDE USE IN PATIENTS WITH PRE-EXISTING LIVER DISEASE, OR THOSE WITH SERUM ALANINE AMINOTRANSFERASE (ALT) >2XULN. (5.2, 8.6) · USE CAUTION WHEN LEFLUNOMIDE IS GIVEN WITH OTHER POTENTIALLY HEPATOTOXIC DRUGS. (5.2) MONITOR ALT LEVELS. INTERRUPT LEFLUNOMIDE TREATMENT IF ALT ELEVATION > 3 FOLD ULN. IF LIKELY LEFLUNOMIDE- INDUCED, START ACCELERATED DRUG ELIMINATION PROCEDURE AND MONITOR LIVER TESTS WEEKLY UNTIL NORMALIZED. (5.2, 5.3) INDICATIONS AND USAGE Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1) (1) 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) (2) · Maintenance dosage: 20 mg daily. (2.1) (2) Maximum recommended daily dosage: 20 mg once daily. (2.1) (2) If 20 mg once daily is not tolerated, may decrease dosage to 10 mg once daily. (2.1) (2) · Screen patients for active and latent tuberculosis, pregnancy t Прочитайте повний документ