LEFLUNOMIDE - leflunomide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trigen Laboratories, LLC

INN (International Name):

LEFLUNOMIDE

Composition:

LEFLUNOMIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).  Leflunomide is contraindicated in: ·            Pregnant women. Leflunomide may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide, 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. 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 registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. Health care providers and patients are encouraged to report pr

Product summary:

How Supplied Leflunomide tablets USP, 10 mg are white to off white, circular, biconvex, film coated tablets debossed with ‘L115’ on one side and plain on the other side, and are supplied as follows: NDC 13811-677-30                 bottles of 30 tablets NDC 13811-677-60                 bottles of 60 tablets NDC 13811-677-10                 bottles of 100 tablets NDC 13811-677-50                 bottles of 500 tablets Leflunomide tablets USP, 20 mg are yellow colored, triangular, biconvex, film coated tablets debossed with ‘L116’ on one side and plain on the other side, and are supplied as follows: NDC 13811-678-30                 bottles of 30 tablets NDC 13811-678-60                 bottles of 60 tablets NDC 13811-678-10                 bottles of 100 tablets NDC 13811-678-50                 bottles of 500 tablets Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEFLUNOMIDE - LEFLUNOMIDE TABLET
TRIGEN LABORATORIES, LLC
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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)
HEPATOTOXICITY
· 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, pregna