Deferasirox

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Deferasirox
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]

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Black Box Warning

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Renal Failure
  • Exjade can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
  • Measure serum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine [see Dosage and Administration (2.4, 2.5), Warnings and Precautions (5.1)].
  • Hepatic Failure
  • Exjade can cause hepatic injury including hepatic failure and death.
  • Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
  • Avoid use of Exjade in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)].
  • Gastrointestinal Hemorrhage
  • Exjade can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
  • Monitor patients and discontinue Exjade for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)].

Overview

Deferasirox is a 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 Deferasirox in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Renal Failure
  • Exjade can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
  • Measure serum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine [see Dosage and Administration (2.4, 2.5), Warnings and Precautions (5.1)].
  • Hepatic Failure
  • Exjade can cause hepatic injury including hepatic failure and death.
  • Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
  • Avoid use of Exjade in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)].
  • Gastrointestinal Hemorrhage
  • Exjade can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
  • Monitor patients and discontinue Exjade for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)].
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Deferasirox 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 Deferasirox 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 Deferasirox in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

{{#ask: Page Name::Deferasirox |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Deferasirox 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.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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