LEFLUNOMIDE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NorthStar RxLLC

INN (Alþjóðlegt nafn):

LEFLUNOMIDE

Samsetning:

LEFLUNOMIDE 10 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LEFLUNOMIDE - LEFLUNOMIDE TABLET
NORTHSTAR RXLLC
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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, 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