Quick answers
- What is Calaspargase pegol used for?
- The FDA-approved label (Asparlas, Servier Pharmaceuticals LLC, October 8, 2024) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Calaspargase pegol have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Calaspargase pegol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calaspargase pegol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Calaspargase pegol?
- 1 company lists prescription products of Calaspargase pegol in the FDA NDC Directory, including Servier Pharmaceuticals LLC.
What Calaspargase pegol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Asparlas, Servier Pharmaceuticals LLC, effective October 8, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Asparlas |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Servier Pharmaceuticals LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761102 ASPARLAS | Servier Pharma LLC | December 20, 2018 | 4, latest November 29, 2023 2023: Labeling · 2021: Labeling · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2121421, 2121426 |
|---|---|
| SPL set ID of the quoted label | 6585bd0d-bd78-4341-9e87-0f7664821f05 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761102 |
| Active ingredients (FDA) | CALASPARGASE PEGOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Asparlas, Servier Pharmaceuticals LLC, effective October 8, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →