Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)
sanofi-aventis U.S. LLC
leflunomide
leflunomide 10 mg
ORAL
PRESCRIPTION DRUG
ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is contraindicated in: - Pregnant women. ARAVA may cause fetal harm. If a woman becomes pregnant while taking this drug, stop ARAVA, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1, 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 ARAVA. 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
How Supplied ARAVA (leflunomide) Tablets 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.
New Drug Application
ARAVA- LEFLUNOMIDE TABLET, FILM COATED SANOFI-AVENTIS U.S. LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ARAVA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARAVA. ARAVA (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 ARAVA 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 ARAVA 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 ARAVA USE IN PATIENTS WITH PRE-EXISTING LIVER DISEASE, OR THOSE WITH SERUM ALANINE AMINOTRANSFERASE (ALT) >2 × ULN. ( 5.2, 8.6) USE CAUTION WHEN ARAVA IS GIVEN WITH OTHER POTENTIALLY HEPATOTOXIC DRUGS. ( 5.2) MONITOR ALT LEVELS. INTERRUPT ARAVA 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 ARAVA is 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 ARAVA-associated hepatotoxicity and ARAVA-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 ARAVA. ( 2.2) DOSAGE FORM Lue koko asiakirja