|
|
| (10 intermediate revisions by 2 users not shown) |
| Line 1: |
Line 1: |
| {{DrugProjectFormSinglePage
| | #REDIRECT [[L-Asparaginase]] |
| |authorTag=<!--Overview-->
| |
| |aOrAn=a
| |
| |indicationType=treatment
| |
| |indication=as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
| |
| |hasBlackBoxWarning=Yes
| |
| |adverseReactions=<!--Black Box Warning-->
| |
| |blackBoxWarningTitle=Title
| |
| |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
| |
| | |
| * Content
| |
| | |
| <!--Adult Indications and Dosage-->
| |
| | |
| <!--FDA-Labeled Indications and Dosage (Adult)-->
| |
| |fdaLIADAdult======Acute lymphoblastic leukemia (ALL)=====
| |
| *Asparaginase is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.
| |
| =====Recommended Dose=====
| |
| *To substitute for a dose of pegaspargase:
| |
| :*The recommended dose for each planned dose of pegaspargase is 25,000 International Units/m2 administered intramuscularly or intravenously three times a week (Monday/Wednesday/Friday) for six doses.
| |
| *To substitute for a dose of native E. coli asparaginase:
| |
| :*The recommended dose is 25,000 International Units/m2 administered intramuscularly or intravenously for each scheduled dose of native E. coli asparaginase within a treatment.
| |
| :*When administering ERWINAZE intravenously, consider monitoring nadir (pre-dose) serum asparaginase activity (NSAA) levels and switching to intramuscular administration if desired NSAA levels are not achieved [see Clinical Pharmacology (12.3)].
| |
| ===== Preparation and Handling Instructions=====
| |
| *Visually inspect the ERWINAZE powder for foreign particulate matter and discoloration prior to reconstitution. Discard vial if present.
| |
| *Reconstitute the contents of each vial by slowly injecting 1 or 2 mL of preservative free sterile sodium chloride (0.9%) injection (USP) against the inner vial wall.
| |
| *Do not forcefully inject solution for reconstitution directly onto or into the powder. When reconstituted with 1 mL the resultant concentration is 10,000 International Units per mL. When reconstituted with 2 mL the resultant concentration is 5,000 International Units per mL.
| |
| *Dissolve contents by gentle mixing or swirling. Do not shake or invert vial.
| |
| *When reconstituted, ERWINAZE should be a clear, colorless solution. Inspect the solution after reconstitution and discard if any visible particles or protein aggregates are present.
| |
| *Calculate the dose needed and the volume needed to obtain the calculated dose.
| |
| *Withdraw the volume containing the calculated dose from the vial into a polypropylene syringe within 15 minutes of reconstitution. For intravenous use, slowly inject the reconstituted ERWINAZE into an IV infusion bag containing 100 mL of normal saline acclimatized to room temperature. Do not shake or squeeze the IV bag.
| |
| *If partial vial is used, do not save or reuse the unused drug for later administration. Discard unused portions.
| |
| * Do not freeze or refrigerate reconstituted solution and administer within 4 hours or discard [see How Supplied/Storage and Handling (16)].
| |
| | |
| =====Administration Instructions=====
| |
| *ERWINAZE solution can be administered by intramuscular injection or by intravenous infusion.
| |
| *For intramuscular use, limit the volume of reconstituted ERWINAZE at a single injection site to 2 mL; if reconstituted dose to be administered is greater than 2 mL, use multiple injection sites.
| |
| *For intravenous use, infuse ERWINAZE in 100 mL of normal saline over 1 hour. Do not infuse other intravenous drugs through the same intravenous line while infusing ERWINAZE.
| |
| | |
| | |
| |offLabelAdultGuideSupport======Condition1=====
| |
| | |
| * Developed by:
| |
| | |
| * Class of Recommendation:
| |
| | |
| * Strength of Evidence:
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| |
| | |
| <!--Non–Guideline-Supported Use (Adult)-->
| |
| |offLabelAdultNoGuideSupport======Condition1=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| |
| | |
| <!--Pediatric Indications and Dosage-->
| |
| | |
| <!--FDA-Labeled Indications and Dosage (Pediatric)-->
| |
| |fdaLIADPed======Condition1=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
| |
| | |
| <!--Off-Label Use and Dosage (Pediatric)-->
| |
| | |
| <!--Guideline-Supported Use (Pediatric)-->
| |
| |offLabelPedGuideSupport======Condition1=====
| |
| | |
| * Developed by:
| |
| | |
| * Class of Recommendation:
| |
| | |
| * Strength of Evidence:
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| |
| | |
| <!--Non–Guideline-Supported Use (Pediatric)-->
| |
| |offLabelPedNoGuideSupport======Condition1=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| |
| | |
| <!--Contraindications-->
| |
| |contraindications=* History of serious hypersensitivity reactions to ERWINAZE, including anaphylaxis
| |
| *History of serious pancreatitis with prior L-asparaginase therapy
| |
| *History of serious thrombosis with prior L-asparaginase therapy
| |
| *History of serious hemorrhagic events with prior L-asparaginase therapy
| |
| <!--Warnings-->
| |
| |warnings======Hypersensitivity Reactions=====
| |
| *Grade 3 and 4 hypersensitivity reactions after the use of ERWINAZE have occurred in 5% of patients in clinical trials [see Adverse Reactions (6.1)].
| |
| *Administer this product in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. If a serious hypersensitivity reaction occurs, discontinue ERWINAZE and initiate appropriate therapy.
| |
| =====Pancreatitis=====
| |
| *Pancreatitis has been reported in 4% of patients in clinical trials.
| |
| *Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Discontinue ERWINAZE for severe or hemorrhagic pancreatitis manifested by abdominal pain > 72 hours and amylase elevation ≥ 2.0 x ULN. Severe pancreatitis is a contraindication to additional asparaginase administration. In the case of mild pancreatitis, hold ERWINAZE until the signs and symptoms subside and amylase levels return to normal. After resolution, treatment with ERWINAZE may be resumed.
| |
| ===== Glucose Intolerance=====
| |
| *Glucose intolerance has been reported in 5% of patients receiving ERWINAZE in clinical trials [see Adverse Reactions (6.1)]. In some cases glucose intolerance may be irreversible. Monitor glucose levels in patients at baseline and periodically during treatment. Administer insulin therapy as necessary in patients with hyperglycemia.
| |
| =====Thrombosis and Hemorrhage=====
| |
| *Serious thrombotic events, including sagittal sinus thrombosis and pulmonary embolism have been reported with both E. coli and Erwinia-derived L-asparaginase therapy. The following coagulation proteins were decreased in the majority of patients after a 2-week course of ERWINAZE by intramuscular administration: fibrinogen, protein C activity, protein S activity, and anti-thrombin III. *Discontinue ERWINAZE for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, treatment with ERWINAZE may be resumed.
| |
| | |
| | |
| | |
| <!--Adverse Reactions-->
| |
| | |
| <!--Clinical Trials Experience-->
| |
| |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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-->
| |
| |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
| |
| |drugInteractions=* Drug
| |
| :* Description
| |
| | |
| <!--Use in Specific Populations-->
| |
| |useInPregnancyFDA=* '''Pregnancy Category'''
| |
| |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
| |
| | |
| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
| |
| |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
| |
| |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
| |
| |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
| |
| |useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
| |
| |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
| |
| |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
| |
| |useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
| |
| |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
| |
| |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
| |
| |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
| |
| | |
| <!--Administration and Monitoring-->
| |
| |administration=* Oral
| |
| | |
| * Intravenous
| |
| |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
| |
| | |
| * Description
| |
| | |
| <!--IV Compatibility-->
| |
| |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Overdosage-->
| |
| |overdose====Acute Overdose===
| |
| | |
| ====Signs and Symptoms====
| |
| | |
| * Description
| |
| | |
| ====Management====
| |
| | |
| * Description
| |
| | |
| ===Chronic Overdose===
| |
| | |
| There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Pharmacology-->
| |
| | |
| <!--Drug box 2-->
| |
| |drugBox=<!--Mechanism of Action-->
| |
| |mechAction=*
| |
| | |
| <!--Structure-->
| |
| |structure=*
| |
| | |
| : [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
| |
| | |
| <!--Pharmacodynamics-->
| |
| |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Pharmacokinetics-->
| |
| |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Nonclinical Toxicology-->
| |
| |nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Clinical Studies-->
| |
| |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--How Supplied-->
| |
| |howSupplied=*
| |
| | |
| <!--Patient Counseling Information-->
| |
| |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Precautions with Alcohol-->
| |
| |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
| |
| | |
| <!--Brand Names-->
| |
| |brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
| |
| | |
| <!--Look-Alike Drug Names-->
| |
| |lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
| |
| | |
| <!--Drug Shortage Status-->
| |
| |drugShortage=
| |
| }}
| |
| {{PillImage
| |
| |fileName=No image.jpg
| |
| }}
| |
| {{LabelImage
| |
| |fileName={{PAGENAME}}11.png
| |
| }}
| |
| {{LabelImage
| |
| |fileName={{PAGENAME}}11.png
| |
| }}
| |
| <!--Pill Image-->
| |
| | |
| | |
| | |
| <!--Label Display Image-->
| |
| | |
| | |
| | |
| | |
| | |
| <!--Category-->
| |
| | |
| [[Category:Drug]]
| |