Prescription medicine
Pegaspargase Brand names: Oncaspar
Pegaspargase (Oncaspar) is a prescription medicine with an FDA approval on record since 1994. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pegaspargase FDA label on DailyMed (effective October 7, 2024, Servier Pharmaceuticals LLC); the BLA 103411 record on Drugs@FDA; every pegaspargase label on DailyMed.
Highlights of the record
FDA label of October 7, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageONCASPAR 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 ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for th
Forms and strengths
Injection (solution).
On the market
- Earliest approval on file
- February 1, 1994 Oncaspar, Sigma Tau; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,172 through July 30, 2026
What is pegaspargase used for?
From the label: indications and usageONCASPAR 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 ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase. […]
Conditions named in the indications of pegaspargase's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Asparagine-specific Enzyme.
Source: FDA drug label (ONCASPAR), BLA103411 (Sigma Tau), as published by Servier Pharmaceuticals LLC, effective October 7, 2024 (SPL set ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce), via openFDA; the full label on DailyMed
Is there a generic for pegaspargase (Oncaspar)?
No generic pegaspargase is approved (Drugs@FDA, October 8, 2026).
- 1994 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pegaspargase label say about other medicines?
The pegaspargase label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | drug interactions | DRUG INTERACTIONS 7.1 Glucocorticoids Pegaspargase may increase the risk of glucocorticoid-induced toxicities, including osteonecrosis through a potential increase in exposure of dexamethasone [see Adverse Reactions (6.3) ]. |
| Epinephrine | warnings and precautions | Observe patients for 1 hour after administration of ONCASPAR in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines) [see Dosage and Administration (2.4) ]. |
Source: FDA drug label (ONCASPAR), BLA103411 (Sigma Tau), as published by Servier Pharmaceuticals LLC, effective October 7, 2024 (SPL set ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce), via openFDA; the full label on DailyMed
What do FAERS reports show for pegaspargase?
The FDA Adverse Event Reporting System holds 12,172 reports that list pegaspargase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,557 are coded as a death and 7,468 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (2,817, against a median of 810 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other asparagine-specific enzymes
- the pharmacologic class, with prices and generics
- Pegaspargase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other