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Molecule

Pegaspargase

Asparagine-specific Enzyme
Available on requestBiologicOrphanCold chainOncology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Pegaspargase is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with first-line acute lymphoblastic leukemia, among other approved uses. MedsAcross supplies Pegaspargase 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

Key facts

Pharmacological class
Asparagine-specific Enzyme
ATC classification
L01XX24 Pegaspargase · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XX
US FDA first approval
1 February 1994
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intramuscular, Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 7D96IR0PPMRxCUI 34132CAS 130167-69-0DrugBank DB00059Q7160547

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia. Acute lymphoblastic leukemia and hypersensitivity to asparaginase

Source: US FDA prescribing information

How it works

L-asparaginase is an enzyme that catalyzes the conversion of the amino acid L-asparagine into aspartic acid and ammonia. The pharmacological effect of ONCASPAR 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

Dosing overview

Administered intramuscularly or intravenously no more frequently than every 14 days. Patients ages 21 years and younger: 2,500 International Units/m 2. Patients ages over 21 years: 2,000 International Units/m 2. For intramuscular administration, limit the volume at a single injection site to 2 mL, if greater than 2 mL, use multiple injection sites. For intravenous administration, give over a period of 1 to 2 hours in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP through an infusion that is already running. Do not administer ONCASPAR if drug has been frozen, stored at room temperature for more than 48 hours, or shaken or vigorously agitated.

Source: US FDA prescribing information

Contraindications

ONCASPAR is contraindicated in patients with a: History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients. History of serious thrombosis with prior L-asparaginase therapy. History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy. History of serious hemorrhagic events with prior L-asparaginase therapy. Severe hepatic impairment. History of serious hypersensitivity reactions to ONCASPAR. History of pancreatitis with prior L-asparaginase therapy.

Source: US FDA prescribing information

Warnings and precautions

Anaphylaxis or serious hypersensitivity reactions: Observe patients for 1 hour after administration. Discontinue ONCASPAR in patients with serious hypersensitivity reactions. Thrombosis: Discontinue ONCASPAR in patients with serious thrombotic events. Pancreatitis: Evaluate patients with abdominal pain for pancreatitis. Discontinue ONCASPAR in patients with pancreatitis. Glucose intolerance: Monitor serum glucose. Hemorrhage: Discontinue ONCASPAR 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 ONCASPAR for severe liver toxicity.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and serious hypersensitivity reactions Thrombosis Pancreatitis Glucose intolerance Hemorrhage Hepatotoxicity, including VOD The most common (>5%) grade > 3 adverse reactions with ONCASPAR are hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections.

Source: US FDA prescribing information

Interactions

Glucocorticoids Pegaspargase may increase the risk of glucocorticoid-induced toxicities, including osteonecrosis through a potential increase in exposure of dexamethasone.

Source: US FDA prescribing information

Storage

Store ONCASPAR 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.

All presentations

1 presentations of Pegaspargase, sorted by availability.

MedicineManufacturerRegisterAvailability
Oncaspar 750 IU/mL injectionIntramuscular, intravenous Cold chainServier PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 1 February 1994Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Pegaspargase in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Pegaspargase available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Pegaspargase and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Pegaspargase have?

The catalogue lists 1 brand names for Pegaspargase, including Oncaspar.

Is Pegaspargase approved by the US FDA?

Yes. The US FDA first approved Pegaspargase on 1 February 1994, according to Drugs@FDA.

Is Pegaspargase authorised in the European Union?

Yes. Pegaspargase has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Pegaspargase need cold chain shipping?

At least one listed presentation of Pegaspargase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Pegaspargase in?

Pegaspargase is classified under ATC code L01XX24 (Pegaspargase).

References

  1. ONCASPAR prescribing information (Servier Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 7 October 2024
  2. Oncaspar: European public assessment report (EPAR). European Medicines Agency. Retrieved 7 May 2026

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