Molecule
Calaspargase pegol is an asparagine-specific enzyme indicated 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. MedsAcross supplies Calaspargase pegol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ASPARLAS is an asparagine specific enzyme indicated 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.
Source: US FDA prescribing information
L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ASPARLAS is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine, and therefore depend on an exogenous source of asparagine for survival.
Source: US FDA prescribing information
Recommended Dosage: 2,500 units/m 2 intravenously no more frequently than every 21 days. See Full Prescribing Information for important details regarding dosing modifications and preparation and administration.
Source: US FDA prescribing information
ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy History of serious pancreatitis during previous L-asparaginase therapy History of serious thrombosis during previous L-asparaginase therapy History of serious hemorrhagic events during previous L-asparaginase therapy Severe hepatic impairment History of serious hypersensitivity reactions to pegylated L-asparaginase. History of serious thrombosis during L-asparaginase therapy. History of serious pancreatitis related to previous L-asparaginase treatment. History of serious hemorrhagic events during previous L-asparaginase therapy.
Source: US FDA prescribing information
Hypersensitivity: Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions. Pancreatitis: Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose. Thrombosis: Discontinue ASPARLAS for severe or life-threatening thrombosis. Hemorrhage: Discontinue ASPARLAS for severe or life-threatening hemorrhage. Evaluate for etiology and treat. Hepatotoxicity, including hepatic veno-occlusive disease (VOD): Monitor for toxicity through recovery from cycle. Discontinue ASPARLAS for severe liver toxicity.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Pancreatitis Thrombosis Hemorrhage Hepatotoxicity, including VOD The most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Calaspargase pegol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| asparlas 750 units/mL injectionIntravenous Cold chain | Servier Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 20 December 2018 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Calaspargase pegol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Calaspargase pegol, including asparlas.
Yes. The US FDA first approved Calaspargase pegol on 20 December 2018, according to Drugs@FDA.
At least one listed presentation of Calaspargase pegol must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.