Calaspargase pegol

What is Calaspargase pegol?[edit | edit source]

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

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.

(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.

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.

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

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

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.

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.

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.

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

Active ingredient:

Inactive ingredients:

Boston, MA 02210 U.S. License No. 2125

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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