Asparaginase Erwinia Chrysanthemi Injection
Asparaginase Erwinia Chrysanthemi Injection is an enzyme-based cancer medicine used as part of combination chemotherapy to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients who have had an allergic reaction to E. coli-derived asparaginase.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Asparaginase Erwinia Chrysanthemi Injection: Patient Information Guide
A plain-language walkthrough of Asparaginase Erwinia Chrysanthemi Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Rylaze (asparaginase erwinia chrysanthemi injection) is an enzyme used as part of combination chemotherapy for certain blood cancers in patients who can no longer receive E. coli-based asparaginase due to an allergic reaction.
- Rylaze is indicated for the treatment of acute lymphoblastic leukemia (ALL) in adults and pediatric patients 1 month of age or older who have developed hypersensitivity to E. coli-derived asparaginase
- Rylaze is indicated for the treatment of lymphoblastic lymphoma (LBL) in adults and pediatric patients 1 month of age or older who have developed hypersensitivity to E. coli-derived asparaginase
- Rylaze is used as a replacement for long-acting asparaginase products (such as pegaspargase or calaspargase pegol products) within a patient's overall chemotherapy plan
⚙️How it works▾
Rylaze is an enzyme that breaks down L-asparagine — an amino acid — in the bloodstream, converting it into aspartic acid and ammonia. Leukemic cells have low levels of an enzyme called asparagine synthetase, meaning they cannot manufacture their own asparagine and must pull it from the blood to survive. By rapidly depleting blood asparagine levels, Rylaze cuts off this critical supply, causing cancer cells to die. Normal cells are less affected because they can make their own asparagine internally.
💊How it's taken▾
Rylaze is given only by intramuscular injection (a shot into the muscle) in a healthcare setting — never at home or by IV. There are two approved dosing schedules: one where it is given every 48 hours, and one where it is given on a Monday, Wednesday, and Friday pattern (with the Friday dose being larger and given in the afternoon). The number of doses needed depends on which long-acting asparaginase product Rylaze is replacing and for how long. Your oncology team will determine your exact schedule. Never adjust your schedule without guidance from your care team.
- Always given by a healthcare professional in a clinical setting
- Injection sites are rotated with each dose to minimize local reactions
- If a dose volume is large, it may be split into multiple injection sites
- Premedication is given 30–60 minutes before each dose to reduce the risk of allergic reactions
🤒Side effects — in detail▾
Most patients receiving Rylaze as part of chemotherapy experience some side effects. Common ones include:
- Abnormal liver tests (elevated enzymes or bilirubin)
- Nausea or vomiting
- Musculoskeletal pain (muscle or joint aches)
- Fatigue or weakness
- Headache
- Infections (including febrile neutropenia — fever with low white blood cell counts)
- Fever
- Bleeding or bruising (including nosebleeds and easy bruising)
- Decreased appetite, stomach pain, or diarrhea
- High blood sugar (hyperglycemia) and low potassium (hypokalemia)
Serious reactions — including severe allergic reactions, pancreatitis, blood clots, significant bleeding, and liver toxicity — require immediate medical attention. All patients in clinical trials experienced some degree of low blood counts (neutropenia, anemia, or low platelets).
⚠️Warnings & precautions▾
- Serious allergic reactions (hypersensitivity): Occurred in 29% of patients in trials, with severe reactions in 6% and anaphylaxis in 2%. Every dose must be given in a setting equipped to treat anaphylaxis, and patients are premedicated before each injection. Rylaze must be permanently stopped for severe (Grade 3–4) allergic reactions.
- Pancreatitis: Occurred in 20% of patients; severe in 8%. Hemorrhagic or necrotizing (tissue-destroying) pancreatitis has been reported with this class of drugs and can be fatal. Rylaze must be held or permanently discontinued depending on severity.
- Thrombosis (blood clots): Serious clotting events — including clots in the brain's venous sinuses and lungs — were reported in 1% of patients. Severe or life-threatening clots require permanent discontinuation and anticoagulation therapy.
- Hemorrhage (bleeding): Occurred in 25% of patients; severe in 2%. Bleeding may be linked to clotting factor abnormalities. Severe bleeding requires Rylaze to be held and may require clotting factor replacement.
- Hepatotoxicity (liver toxicity), including hepatic veno-occlusive disease (VOD): Elevated liver enzymes occurred in 75% of patients; severe elevations in 26%. Rare but potentially fatal VOD has been reported. Liver tests must be monitored before each treatment cycle and at least weekly during treatment. Rylaze must be discontinued in severe liver toxicity.
🔀What it interacts with▾
The FDA label for Rylaze does not specify individual drug-drug, food, or supplement interactions. However, because it is part of a multi-drug chemotherapy regimen, your oncology pharmacist and care team should review all medications — prescription, over-the-counter, and supplements — before and during treatment.
- Rylaze is used alongside other chemotherapy drugs; the full regimen should be reviewed by your oncology team for potential combined toxicities
- Hormonal contraceptives may be less reliable during treatment — non-hormonal birth control is recommended
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use Rylaze if you have had a serious allergic reaction (including anaphylaxis) to Erwinia asparaginase in the past
- Do not use if you have a history of serious pancreatitis, serious blood clots, or serious bleeding events caused by asparaginase therapy
- Do not use if you have severe liver (hepatic) impairment
- Tell your doctor if you are pregnant — Rylaze can cause fetal harm based on animal studies; pregnancy testing is recommended before starting treatment
- Use effective non-hormonal contraception during treatment and for 3 months after the last dose if you are able to become pregnant
- Do not breastfeed during treatment or for 1 week after the last dose
- Rylaze is approved for patients as young as 1 month of age; it has not been studied in infants younger than 1 month
- There is limited safety data in adults 65 years of age and older
- The effects of kidney or liver impairment on how your body handles Rylaze have not been fully studied; severe liver impairment is a contraindication
📡Pharmacodynamics — effects in the body▾
The relationship between Rylaze exposure levels and its pharmacodynamic response (how it affects the body over time) has not been fully characterized. The drug's therapeutic effect is based on depletion of asparagine from the plasma (blood), which is necessary for leukemic cell survival. The precise exposure-response relationship and the time course of this response remain under study.
🔬Pharmacokinetics — how your body processes it▾
After an intramuscular injection of Rylaze, peak drug activity in the blood is reached at a median of about 12 hours. The drug's apparent half-life — the time it takes for the body to clear half of it — is approximately 16 hours, and it is expected to be broken down into small peptides through normal protein-clearing (catabolic) pathways. Absorption from the muscle is about 37% in healthy subjects. There were no clinically significant differences in how the drug is processed based on age (1.4 to 25 years), weight, or sex when the dose is adjusted for body surface area; however, Black or African American patients showed approximately 29% lower clearance, which may result in higher drug exposure. The effects of kidney or liver impairment have not been formally studied.
📦How to store it▾
Store RYLAZE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
📄 Written from Asparaginase Erwinia Chrysanthemi Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Asparaginase Erwinia Chrysanthemi Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why am I getting Rylaze instead of the asparaginase I was on before? ▾
What should I watch out for after getting my injection? ▾
Will I feel sick from this medication? ▾
Is it safe to use Rylaze if I'm pregnant or trying to get pregnant? ▾
Can I breastfeed while on Rylaze? ▾
How long will I be on Rylaze, and how often do I have to come in for injections? ▾
Is Asparaginase Erwinia Chrysanthemi Injection available over the counter? ▾
When was Asparaginase Erwinia Chrysanthemi Injection first available? ▾
Who makes Asparaginase Erwinia Chrysanthemi Injection? ▾
💬 Answers drafted from Asparaginase Erwinia Chrysanthemi Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Asparaginase Erwinia Chrysanthemi Injection comes
Asparaginase Erwinia Chrysanthemi Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Rylaze is used as part of a multi-agent chemotherapy regimen to treat acute lymphoblastic leukemia (ALL) in adults and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase
- Rylaze is used as part of a multi-agent chemotherapy regimen to treat lymphoblastic lymphoma (LBL) in adults and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase
- Rylaze serves as a replacement for long-acting asparaginase products (such as pegaspargase or calaspargase pegol) when those can no longer be used due to allergic reactions
- Rylaze is administered by intramuscular injection only; the intravenous (IV) route is not approved
- Rylaze injection sites should be rotated and should never be in areas that are scarred, reddened, inflamed, or swollen
- Rylaze can be given on two schedules — every 48 hours, or on a Monday/Wednesday/Friday schedule — as directed by your oncology team
- Rylaze must be given in a medical setting with emergency equipment available to treat serious allergic reactions; patients receive premedication (acetaminophen, antihistamines) 30–60 minutes before each dose
📊 Asparaginase Erwinia Chrysanthemi Injection across the U.S. market
How Asparaginase Erwinia Chrysanthemi Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Asparaginase Erwinia Chrysanthemi Injection is used
A general measure of how commonly Asparaginase Erwinia Chrysanthemi Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Asparaginase Erwinia Chrysanthemi Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Asparaginase Erwinia Chrysanthemi Injection prescribed? Of the 1,594 medications we measure, Asparaginase Erwinia Chrysanthemi Injection ranks #1,295 by Medicaid prescriptions — more than 19% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Asparaginase Erwinia Chrysanthemi Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Asparaginase Erwinia Chrysanthemi Injection NDCs with Medicaid activity.
🔍 Compare Asparaginase Erwinia Chrysanthemi Injection products
A representative set of FDA-listed product records for Asparaginase Erwinia Chrysanthemi Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 20 mg/mL | Intramuscular | Jazz Pharmaceuticals, Inc. × 3 listings | BLA | View NDC → |
| 20 mg/mL | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Asparaginase Erwinia Chrysanthemi Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Asparaginase Erwinia Chrysanthemi Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Asparaginase Erwinia Chrysanthemi Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Asparaginase Erwinia Chrysanthemi Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Asparaginase Erwinia Chrysanthemi Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Asparaginase Erwinia Chrysanthemi Injection belongs to the Asparagine-specific Enzyme class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Jazz Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.