Calaspargase pegol

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.

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 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?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

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.

• Dailymed label info on Calaspargase pegol
• FDA Calaspargase pegol

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