LEFLUNOMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

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)]. 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 pregnancies by calli

Product summary:

How Supplied Leflunomide Tablets   USP, 10 mg are white to off-white, round biconvex film-coated tablets debossed  with ‘LF’ on one side and ‘10’ on other side. They are supplied as follows: Bottles of 30                                       NDC 59651-348-30 Leflunomide Tablets   USP, 20 mg are light yellow to yellow, round biconvex film-coated tablets debossed  with ‘LF’ on one side and ‘20’ on other side. They are supplied as follows: Bottles of 30                                       NDC 59651-349-30 Store at  20° to  25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEFLUNOMIDE - LEFLUNOMIDE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
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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)
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)
Screen patients for active and latent tuberculosis, pregnancy test
(females), bloo