Prescription medicine
Asparaginase Brand names: Rylaze; first approved as Elspar
Asparaginase (Rylaze) is a prescription medicine with an FDA approval on record since 1978. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the asparaginase FDA label on DailyMed (effective July 1, 2025); the BLA 101063 record on Drugs@FDA; every asparaginase label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E.
Forms and strengths
- 20 mg/ml
Injection.
On the market
- Earliest approval on file
- January 10, 1978 Elspar, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 309 through July 30, 2026
What is asparaginase used for?
From the label: indications and usageRYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase.
Conditions named in the indications of asparaginase's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Asparagine-specific Enzyme.
Source: FDA drug label (Rylaze), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 857e53aa-1098-4dad-b654-0276cdd43e03), via openFDA; the full label on DailyMed
Is there a generic for asparaginase (Rylaze)?
No generic asparaginase is approved (Drugs@FDA, October 8, 2026).
- 1978 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the asparaginase label say about other medicines?
The asparaginase label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name asparaginase. 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 |
|---|---|---|
| Epinephrine | warnings and precautions | Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer RYLAZE in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines) [see Dosage and Administration ( 2.3 )]. |
Other labels that name asparaginase
Source: FDA drug label (Rylaze), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 857e53aa-1098-4dad-b654-0276cdd43e03), via openFDA; the full label on DailyMed
What do FAERS reports show for asparaginase?
The FDA Adverse Event Reporting System holds 309 reports that list asparaginase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 98 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as asparaginase?
2 other medicines are given the same way (intramuscular) and in the same FDA class as asparaginase or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intramuscular) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pegaspargase | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Bleomycin | Leukemia, lymphoma and myeloma | 5 labelers | $26.45 per vial 15 unit vial | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other asparagine-specific enzymes
- the pharmacologic class, with prices and generics
- Asparaginase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other