Rasburicase: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{RB}}
|genericName=Rasburicase
|aOrAn=a
|aOrAn=a
|drugClass=recombinant urate-oxidase
|indicationType=treatment
|indication=plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=vomiting, nausea, pyrexia, peripheral edema, anxiety, headache, abdominal pain, constipation, and diarrhea
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content


<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--Black Box Warning-->
|fdaLIADAdult======Condition1=====
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Dosing Information
* ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
Anaphylaxis


:* Dosage
Elitek® can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)].


=====Condition2=====
Hemolysis


* Dosing Information
Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)].


:* Dosage
Methemoglobinemia


=====Condition3=====
Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.3)].


* Dosing Information
Interference with Uric Acid Measurements


:* Dosage
Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection


=====Condition4=====
<!--Adult Indications and Dosage-->


* Dosing Information
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=====Indications====
:* Dosage
* Elitek® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.


<!--Off-Label Use and Dosage (Adult)-->
Limitation of use: Elitek is indicated only for a single course of treatment


<!--Guideline-Supported Use (Adult)-->
====Dosage====
* The recommended dose of Elitek is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Line 264: Line 267:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Intravenous infusion
 
=====Reconstitution Procedure=====
* Elitek must be reconstituted with the diluent provided in the carton.
Reconstitute the 1.5 mg vial of Elitek with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.
Inspect reconstituted Elitek visually for particulate matter and discoloration prior to administration. Discard solution if particulate matter is visible or product is discolored.


* Intravenous
=====Further Dilution and Administration=====
* Do not administer Elitek as a bolus injection.
* Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
* Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.
* Do not use filters during reconstitution or infusion of Elitek.
* Store reconstituted or diluted solution at 2–8°C.
* Discard unused product solution 24 hours following reconstitution.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


Revision as of 22:51, 28 January 2015

Rasburicase
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

Anaphylaxis

Elitek® can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)].

Hemolysis

Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)].

Methemoglobinemia

Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.3)].

Interference with Uric Acid Measurements

Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection

Overview

Rasburicase is a recombinant urate-oxidase that is FDA approved for the treatment of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. There is a Black Box Warning for this drug as shown here. Common adverse reactions include vomiting, nausea, pyrexia, peripheral edema, anxiety, headache, abdominal pain, constipation, and diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Elitek® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Limitation of use: Elitek is indicated only for a single course of treatment

Dosage

  • The recommended dose of Elitek is 0.2 mg/kg as a 30 minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.

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 Rasburicase in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS

Anaphylaxis

Elitek® can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek in patients who experience a serious hypersensitivity reaction [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)].

Hemolysis

Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)].

Methemoglobinemia

Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek in patients developing methemoglobinemia [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.3)].

Interference with Uric Acid Measurements

Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Intravenous infusion
Reconstitution Procedure
  • Elitek must be reconstituted with the diluent provided in the carton.

Reconstitute the 1.5 mg vial of Elitek with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex. Inspect reconstituted Elitek visually for particulate matter and discoloration prior to administration. Discard solution if particulate matter is visible or product is discolored.

Further Dilution and Administration
  • Do not administer Elitek as a bolus injection.
  • Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
  • Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.
  • Do not use filters during reconstitution or infusion of Elitek.
  • Store reconstituted or diluted solution at 2–8°C.
  • Discard unused product solution 24 hours following reconstitution.

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Rasburicase01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Rasburicase 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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