Prab at 16:50, 22 March 2025

2025-03-22T16:50:55Z

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2025-03-17T05:57:24Z

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2025-02-10T09:19:22Z

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Deepika vegiraju at 13:59, 8 June 2022

2022-06-08T13:59:09Z

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== '''What is Calaspargase pegol?''' ==

* Calaspargase pegol ('''Asparlas''') is an '''asparagine specific enzyme''' used for the treatment of [[acute lymphoblastic leukemia]] in pediatric and young adult.

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== '''What are the uses of this medicine?''' ==

* This medicine is used as a component of a multi-agent [[chemotherapeutic]] regimen for the treatment of [[acute lymphoblastic leukemia]] in pediatric and young adult patients age 1 month to 21 years.

== '''How does this medicine work?''' ==

* (kal-AS-par-jays PEH-gol)A drug used with other drugs to treat [[Acute lymphoblastic leukemia|acute lymphoblastic lymphoma]] in children and young adults aged 1 month to 21 years.
* Calaspargase pegol is a form of the drug [[L-asparaginase]] that is linked to a substance called SC-PEG, which makes the drug stay in the body longer.
* L-asparaginase is an '''enzyme taken from the bacterium Escherichia coli''' (E. coli).
* It '''breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow'''.
* Calaspargase pegol is a type of protein synthesis inhibitor.
* Also called Asparlas, EZN-2285, and SC-PEG E. coli L-asparaginase.
* The pharmacological effect of Asparlas is thought to be based on '''selective killing of leukemic cells due to depletion of plasma L-asparagine'''.
* Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize L-asparagine, and therefore depend on an exogenous source of L-asparagine for survival.

== '''Who Should Not Use this medicine ?''' ==

* This medcine cannot be used in patients with:
* History of serious [[hypersensitivity]] reactions to pegylated L-asparaginase
* History of serious thrombosis during previous [[L-asparaginase]] therapy
* History of serious [[pancreatitis]] during previous L-asparaginase therapy
* History of serious hemorrhagic events during previous L-asparaginase therapy
* Severe hepatic impairment

== '''What drug interactions can this medicine cause?''' ==

* No clinically important drug interactions have been observed with Asparlas.

== '''Is this medicine FDA approved?''' ==

* It was approved for use in the United States in 2018.

== '''How should this medicine be used?''' ==

'''Recommended Dosage '''
The recommended dose of Asparlas is '''2,500 units/m2''' given intravenously no more frequently than every 21 days.

'''Administration'''
* Asparlas is a clear and colorless solution.
* Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration.
* If any of these are present, discard the vial. Do not administer if Asparlas has been shaken or vigorously agitated, frozen, or stored at room temperature for more than 48 hours.
* Dilute Asparlas in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP using sterile/aseptic technique.
* Discard any unused portion left in a vial.
* After dilution, administer immediately into a running infusion of either 0.9% sodium chloride or 5% dextrose, respectively.
* Administer the dose over a period of 1 hour.
* Do not infuse other drugs through the same intravenous line during administration of Asparlas.
* The diluted solution may be stored for up to 4 hours at room temperature (15°C to 25°C [59°F to 77°F]) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
* Protect from light.
* Do not shake or freeze.

== '''What are the dosage forms and brand names of this medicine?''' ==

This medicine is available in fallowing doasage form:
* '''As Injection:''' 3,750 units/5 mL (750 units/mL) in a single-dose vial

This medicine is available in fallowing brand namesː
*'''Asparlas'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
'''elevated transaminase
bilirubin increased
pancreatitis
abnormal clotting studies'''

==''' What special precautions should I follow?''' ==

* [[Hypersensitivity]] reactions including anaphylaxis have been reported in clinical trials with Asparlas. Observe patients for one hour after administration. Discontinue Asparlas in patients with serious hypersensitivity reactions.
* Cases of [[pancreatitis]] have been reported in clinical trials with Asparlas. Discontinue Asparlas in patients with pancreatitis. Monitor blood glucose.
* Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with Asparlas. Discontinue Asparlas for severe or life-threatening thrombosis.
* Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen. Discontinue Asparlas for severe or life-threatening hemorrhage. Evaluate for etiology and treat.
* [[Hepatotoxicity]] and abnormal liver function, including elevations of [[transaminase]], [[bilirubin]] (direct and indirect), reduced serum albumin, and plasma [[fibrinogen]] can occur. Monitor for toxicity through recovery from cycle. Discontinue Asparlas for severe liver toxicity.

== '''What to do in case of emergency/overdose?''' ==

* {{overdose}}

== '''Can this medicine be used in pregnancy?''' ==

* Asparlas can cause fetal harm when administered to a pregnant woman.
* There are no available data on Asparlas use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

=='''Can this medicine be used in children?'''==

* The safety and effectiveness of Asparlas in the treatment of ALL have been established in pediatric patients 1 month to < 17 years.

== '''What are the active and inactive ingredients in this medicine?''' ==

'''Active ingredient:'''
* CALASPARGASE PEGOL

Inactive ingredients:
* SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
* SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
* SODIUM CHLORIDE
* WATER

== '''Who manufactures and distributes this medicine?''' ==
* Servier Pharmaceuticals LLC
Boston, MA 02210
U.S. License No. 2125

== '''What should I know about storage and disposal of this medication?''' ==

* Store Asparlas refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
* Do not shake or freeze product.
* Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.

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[[Category:Antineoplastic drugs]]
[[Category:Engineered proteins]]
[[Category:Orphan drugs]]

Calaspargase pegol - Revision history

Prab at 16:50, 22 March 2025

Prab: CSV import

Prab: CSV import

Deepika vegiraju at 13:59, 8 June 2022