ARAVA- leflunomide tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

LEFLUNOMIDE (UNII: G162GK9U4W) (LEFLUNOMIDE - UNII:G162GK9U4W)

Disponible depuis:

sanofi-aventis U.S. LLC

DCI (Dénomination commune internationale):

leflunomide

Composition:

leflunomide 10 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

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.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

ARAVA- LEFLUNOMIDE TABLET, FILM COATED
SANOFI-AVENTIS U.S. LLC
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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