Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
LEFLUNOMIDE
LEFLUNOMIDE 10 mg
ORAL
PRESCRIPTION DRUG
Leflunomide tablets, USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablets are contraindicated in: •Pregnant women. Leflunomide may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1and 5.3) and Use in Specific Populations (8.1)]. •Patients with severe hepatic impairment [see Warnings and Precautions (5.2)] . •Patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. Known reactions include anaphylaxis [see Adverse Reactions (6.1)] . •Patients being treated with teriflunomide [see Drug Interactions (7)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. Health care providers and patients are encouraged to report pregnancies by calling 1-877-3
How Supplied Leflunomide Tablets, USP Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
LEFLUNOMIDE - LEFLUNOMIDE TABLET HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEFLUNOMIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEFLUNOMIDE TABLETS, USP. LEFLUNOMIDE TABLETS, USP 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 TABLETS 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 TABLETS AND USE AN ACCELERATED DRUG ELIMINATION PROCEDURE IF THE PATIENT BECOMES PREGNANT. (5.1, 5.3, 8.1) HEPATOTOXICITY 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 tablets, USP are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (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) 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 activ Læs hele dokumentet