Pegaspargase: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|genericName=generic name
|authorTag={{AP}}
|aOrAn=a
|genericName=Pegaspargase
|drugClass=Adrenergic receptor agonist
|aOrAn=an
|indication=a list of indications, separated by commas.
|drugClass=[[asparginase]]
|hasBlackBoxWarning=Yes
|indicationType=treatment
|adverseReactions=a list of adverse reactions, separated by commas.
|indication=[[acute lymphoblastic leukemia]] ([[ALL]]) and [[acute lymphoblastic leukemia]] and hypersensitivity to [[asparaginase]]
|adverseReactions=allergic reactions (including [[anaphylaxis]]), [[central nervous system thrombosis]], [[coagulopathy]], [[elevated transaminases]], [[hyperbilirubinemia]], [[hyperglycemia]], and [[pancreatitis]]
|blackBoxWarningTitle=Warning Title
|blackBoxWarningTitle=Warning Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
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:* (Dosage)
:* (Dosage)
|contraindications=* Condition 1
|contraindications=*History of serious [[allergic reactions]] to Oncaspar.
* Condition 2
*History of serious [[thrombosis]] with prior [[L-asparaginase]] therapy.
* Condition 3
*History of [[pancreatitis]] with prior [[L-asparaginase]] therapy.
* Condition 4
*History of serious [[hemorrhagic events]] with prior [[L-asparaginase]] therapy.
* Condition 5
|warnings=====Anaphylaxis and Serious Allergic Reactions====
|warnings======Conidition 1=====
*[[Anaphylaxis]] and serious [[allergic reactions]] can occur in patients receiving Oncaspar®. The risk of serious allergic reactions is higher in patients with known [[hypersensitivity]] to other forms of [[L-asparaginase]]. Observe patients for 1 hour after administration of Oncaspar® in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, [[epinephrine]], [[oxygen]], intravenous [[steroids]], [[antihistamines]]). Discontinue Oncaspar® in patients with serious [[allergic reactions]].


(Description)
====Thrombosis====
*Serious [[thrombotic events]], including [[sagittal sinus thrombosis]] can occur in patients receiving Oncaspar®. Discontinue Oncaspar® in patients with serious [[thrombotic events]].
 
====Pancreatitis====
*[[Pancreatitis]] can occur in patients receiving Oncaspar®. Evaluate patients with abdominal pain for evidence of [[pancreatitis]]. Discontinue Oncaspar® in patients with [[pancreatitis]].
 
====Glucose Intolerance====
*[[Glucose intolerance]] can occur in patients receiving Oncaspar®. In some cases, [[glucose intolerance]] is irreversible. Monitor serum [[glucose]].
 
====Coagulopathy====
*Increased [[prothrombin time]], increased partial [[thromboplastin time]], and [[hypofibrinogenemia]] can occur in patients receiving Oncaspar®. Monitor coagulation parameters at baseline and periodically during and after treatment. Initiate treatment with fresh-frozen plasma to replace coagulation factors in patients with severe or symptomatic coagulopathy.


====Hepatotoxicity and Abnormal Liver Function====
*Hepatotoxicity and abnormal liver function, including elevations of [[AST]] ([[SGOT]]), [[ALT]] ([[SGPT]]), [[alkaline phosphatase]], [[bilirubin]] (direct and indirect), and depression of serum [[albumin]], and plasma [[fibrinogen]] can occur. Perform appropriate monitoring.
|clinicalTrials=======Central Nervous System======
|clinicalTrials=======Central Nervous System======


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|othersTitle=Others
|othersTitle=Others
|useInOthers=(Description)
|useInOthers=(Description)
|administration=(Oral/Intravenous/etc)
|administration=(Oral/Intravenous/etc)
|monitoring======Condition 1=====
|monitoring======Condition 1=====
Line 440: Line 452:
|howSupplied=(Description)
|howSupplied=(Description)
|fdaPatientInfo=(Patient Counseling Information)
|fdaPatientInfo=(Patient Counseling Information)
|nlmPatientInfo=(Link to patient information page)
|alcohol=Alcohol-Pegaspargase interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|nlmPatientInfo=(Link to patient information page)
|drugShortage=Drug Shortage
|drugShortage=Drug Shortage
}}
}}

Revision as of 13:45, 17 February 2015

Pegaspargase
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: Alberto Plate [2]

Disclaimer

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Overview

Pegaspargase is an asparginase that is FDA approved for the treatment of acute lymphoblastic leukemia (ALL) and acute lymphoblastic leukemia and hypersensitivity to asparaginase. Common adverse reactions include allergic reactions (including anaphylaxis), central nervous system thrombosis, coagulopathy, elevated transaminases, hyperbilirubinemia, hyperglycemia, and pancreatitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

Warnings

Anaphylaxis and Serious Allergic Reactions

Thrombosis

Pancreatitis

Glucose Intolerance

Coagulopathy

  • Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Oncaspar®. Monitor coagulation parameters at baseline and periodically during and after treatment. Initiate treatment with fresh-frozen plasma to replace coagulation factors in patients with severe or symptomatic coagulopathy.

Hepatotoxicity and Abnormal Liver Function

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Pegaspargase
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

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

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

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

Brand Names

There is limited information regarding Pegaspargase Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

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

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