Label: LEFLUNOMIDE tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 10, 2025

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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 ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY

    Embryo-Fetal Toxicity

    Leflunomide tablet is contraindicated for use in pregnant women because of the potential for fetal harm. Teratogenicity and embryo-lethality occurred in animals administered leflunomide at doses lower than the human exposure level. Exclude pregnancy before the start of treatment with leflunomide tablets in females of reproductive potential. Advise females of reproductive potential to use effective contraception during leflunomide tablets treatment and during an accelerated drug elimination procedure after leflunomide tablets treatment. Stop leflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant. [see Contraindications ( 4), Warnings and Precautions ( 5.1, 5.3), Use in Specific Populations ( 8.1, 8.3)], and Clinical Pharmacology ( 12.3)].

    Hepatotoxicity

    Severe liver injury, including fatal liver failure, has been reported in patients treated with leflunomide tablets. Leflunomide tablet is contraindicated in patients with severe hepatic impairment. Concomitant use of leflunomide tablets with other potentially hepatotoxic drugs may increase the risk of liver injury. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) >2xULN before initiating treatment, are at increased risk and should not be treated with leflunomide tablets. Monitor ALT levels at least monthly for six months after starting leflunomide tablets, and thereafter every 6 to 8 weeks. If leflunomide-induced liver injury is suspected, stop leflunomide tablets treatment, start an accelerated drug elimination procedure, and monitor liver tests weekly until normalized. [see Contraindications ( 4), Warnings and Precautions ( 5.2, 5.3), Use in Specific Populations ( 8.6)].

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  • 1 INDICATIONS AND USAGE
    Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended dosage of leflunomide tablets USP is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Leflunomide tablets are available in two strengths: Tablets: 10 mg, supplied as white to off-white, round film coated tablet, debossed with "L" on one side and "A4" on the other side. Tablets ...
  • 4 CONTRAINDICATIONS
    Leflunomide tablet is contraindicated in: Pregnant women. Leflunomide tablets may cause fetal harm.  If a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Embryo-Fetal Toxicity - Leflunomide tablets may cause fetal harm when administered to a pregnant woman.  Teratogenicity and embryo-lethality occurred in animal reproduction studies with ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the labeling: Hepatotoxicity - [see Warnings and Precautions ( 5.2)] Immunosuppression - [see Warnings ...
  • 7 DRUG INTERACTIONS
    Following oral administration, leflunomide is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of leflunomide's - in vivoactivity.  Drug interaction ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Leflunomide tablet is contraindicated for use in pregnant women because of the potential for fetal harm.  In animal reproduction studies, oral administration of ...
  • 10 OVERDOSAGE
    There have been reports of chronic overdose in patients taking leflunomide tablets at daily dose up to five times the recommended daily dose and reports of acute overdose in adults and children ...
  • 11 DESCRIPTION
    Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide.  It has an empirical formula C - 12H ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Leflunomide is an isoxazole immunomodulatory agent that inhibits dihydroorotate dehydrogenase (a mitochondrial enzyme involved in de novo pyrimidine synthesis) and has ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No evidence of carcinogenicity was observed in a 2-year bioassay in rats at oral doses of leflunomide up to the maximally tolerated ...
  • 14 CLINICAL STUDIES
    The efficacy of leflunomide tablets in the treatment of rheumatoid arthritis (RA) was demonstrated in three controlled trials showing reduction in signs and symptoms, and inhibition of structural ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Leflunomide Tablets USP; 10 mg - StrengthQuantityNDC NumberDescription - 10 mg90 count bottle68071-3763-9White to off-white, round film coated tablet, debossed with ...
  • 17 PATIENT COUNSELING INFORMATION
    Embryo-Fetal Toxicity - Advise females of reproductive potential: Of the potential for fetal harm if leflunomide tablets are taken during pregnancy. To notify their healthcare provider ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108 - United States. Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, India. Revised: October 2024 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    pdp
  • INGREDIENTS AND APPEARANCE
    Product Information