Leflunomide: Difference between revisions

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Revision as of 15:15, 28 October 2014

Leflunomide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

PREGNANCY AND HEPATOTOXICITY
See full prescribing information for complete Boxed Warning.
  • PREGNANCY
  • PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH LEFLUNOMIDE.LEFLUNOMIDE IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMWN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING LEFLUNOMIDE TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINAT PROCEDURE AFTER LEFLUNOMIDE TREATMENT.
  • HEPATOTOXICITY
  • SEVERE LIVER INJURY, INCLUDING FATAL LIVER FAILURE, HAS BEEN REPORTED IN SOME PATIENTS TREATED WITH LEFLUNOMIDE. PATIENTS WITH PRE-EXISTING ACUTE OR CHRONIC LIVER DISEASE, OR THOSE WITH SERUM ALANINE AMINOTRANSFERADE (ALT) >2xULN BEFORE INITIATING TREATMENT, SHOULD NOT BE TREATED WITH LEFLUNOMIDE. USE CAUTION WHEN LEFLUNOMIDE IS GIVEN WITH OTHER POTENTIALLY HEPATOTOXIC DRUGS.
  • MONITORING OF ALT LEVELS IS RECOMMENDED AT LEAST MONTHLY FOR SIX MONTHS AFTER STARTING LEFLUNOMIDE, AND THEREAFTER EVERY SIX TO EIGHT WEEKS. IF ALTELEVATION > 3 FOLD ULN OCCURS, INTERRUPT LEFLUNOMIDE THERAPY WHILE INVESTIGATING THE PROBABLE CAUSE OF THE ALT ELEVATION BY CLOSE OBSERVATION AND ADDITIONAL TESTS. IF LIKELY LEFLUNOMIDE-INDUCED, START CHOLESTYRAMINE WASHOUT AND MONITOR LIVER TESTS WEEKLY UNTIL NORMALIZED. IF LEFLUNOMIDE-INDUCED LIVER INJURY IS UNLIKELY BECAUSE SOME OTHER PROBABLE CAUSE HAS BEEN FOUND, RESUMPTION OF LEFLUNOMIDE THERAPY MAY BE CONSIDERED.

Overview

Leflunomide is a pyrimidine synthesis inhibitor that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Leflunomide in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Leflunomide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Leflunomide in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Leflunomide in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Leflunomide in pediatric patients.

Contraindications

  • Condition1

Warnings

PREGNANCY AND HEPATOTOXICITY
See full prescribing information for complete Boxed Warning.
  • PREGNANCY
  • PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH LEFLUNOMIDE.LEFLUNOMIDE IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMWN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING LEFLUNOMIDE TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINAT PROCEDURE AFTER LEFLUNOMIDE TREATMENT.
  • HEPATOTOXICITY
  • SEVERE LIVER INJURY, INCLUDING FATAL LIVER FAILURE, HAS BEEN REPORTED IN SOME PATIENTS TREATED WITH LEFLUNOMIDE. PATIENTS WITH PRE-EXISTING ACUTE OR CHRONIC LIVER DISEASE, OR THOSE WITH SERUM ALANINE AMINOTRANSFERADE (ALT) >2xULN BEFORE INITIATING TREATMENT, SHOULD NOT BE TREATED WITH LEFLUNOMIDE. USE CAUTION WHEN LEFLUNOMIDE IS GIVEN WITH OTHER POTENTIALLY HEPATOTOXIC DRUGS.
  • MONITORING OF ALT LEVELS IS RECOMMENDED AT LEAST MONTHLY FOR SIX MONTHS AFTER STARTING LEFLUNOMIDE, AND THEREAFTER EVERY SIX TO EIGHT WEEKS. IF ALTELEVATION > 3 FOLD ULN OCCURS, INTERRUPT LEFLUNOMIDE THERAPY WHILE INVESTIGATING THE PROBABLE CAUSE OF THE ALT ELEVATION BY CLOSE OBSERVATION AND ADDITIONAL TESTS. IF LIKELY LEFLUNOMIDE-INDUCED, START CHOLESTYRAMINE WASHOUT AND MONITOR LIVER TESTS WEEKLY UNTIL NORMALIZED. IF LEFLUNOMIDE-INDUCED LIVER INJURY IS UNLIKELY BECAUSE SOME OTHER PROBABLE CAUSE HAS BEEN FOUND, RESUMPTION OF LEFLUNOMIDE THERAPY MAY BE CONSIDERED.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Leflunomide in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Leflunomide in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Leflunomide in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Leflunomide during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Leflunomide with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Leflunomide with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Leflunomide with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Leflunomide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Leflunomide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Leflunomide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Leflunomide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Leflunomide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Leflunomide in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Leflunomide in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Leflunomide in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Leflunomide in the drug label.

Pharmacology

There is limited information regarding Leflunomide Pharmacology in the drug label.

Mechanism of Action

  • Leflunomide is an isoxazole immunomodulatory agent which inhibits dihydroorotate dehydrogenase (an enzyme involved in de novo pyrimidine synthesis) and has antiproliferative activity. Several in vivo and in vitro experimental models have demonstrated an anti-inflammatory effect.

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Leflunomide in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Leflunomide in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Leflunomide in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Leflunomide in the drug label.

How Supplied

Storage

There is limited information regarding Leflunomide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Leflunomide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Leflunomide in the drug label.

Precautions with Alcohol

  • Alcohol-Leflunomide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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