LEFLUNOMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

KVK-Tech, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide Tablets are contraindicated in: - Pregnant women. Leflunomide tablets may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1 and 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) ]. Risk Summary Leflunomide tablets are contraindicated for use in pregnant women because of the potential for fetal harm. In animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of

Product summary:

How Supplied Leflunomide Tablets

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEFLUNOMIDE- LEFLUNOMIDE TABLET
KVK-TECH, INC.
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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 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)
HE PATO TO XIC ITY
SEVERE LIVER INJURY AND FATAL LIVER FAILURE HAVE BEEN REPORTED. (5.2)
AVOID LEFLUNOMIDE TABLETS USE IN PATIENTS WITH PRE-EXISTING LIVER
DISEASE, OR THOSE WITH SERUM ALANINE
AMINOTRANSFERASE (ALT) >2XULN. (5.2, 8.6)
USE CAUTION WHEN LEFLUNOMIDE TABLETS ARE GIVEN WITH OTHER POTENTIALLY
HEPATOTOXIC DRUGS. (5.2)
MONITOR ALT LEVELS. INTERRUPT LEFLUNOMIDE TABLETS 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 are 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
tablets-associated hepatotoxicity and leflunomide tablets-
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) (2)
Screen patients for active and latent tub