LEFLUNOMIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Avera McKennan Hospital

INN (Tarptautinis Pavadinimas):

LEFLUNOMIDE

Sudėtis:

LEFLUNOMIDE 20 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LEFLUNOMIDE- LEFLUNOMIDE TABLET
AVERA MCKENNAN HOSPITAL
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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 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
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: