Pegaspargase Injection
Pegaspargase (Oncaspar) is a chemotherapy enzyme used as part of combination treatment for acute lymphoblastic leukemia (ALL) in children and adults, including patients who have had allergic reactions to other asparaginase medicines.
🧬 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 →
📖 Pegaspargase Injection: Patient Information Guide
A plain-language walkthrough of Pegaspargase 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▾
Pegaspargase (Oncaspar) injection is approved for use in combination with other chemotherapy medicines to treat acute lymphoblastic leukemia (ALL). It covers the following specific situations:
- Oncaspar is used as part of a multi-drug chemotherapy regimen for the first-line (initial) treatment of ALL in both pediatric and adult patients.
- Oncaspar is used as part of a multi-drug chemotherapy regimen for ALL in pediatric and adult patients who have developed hypersensitivity (allergic reactions) to native forms of L-asparaginase — giving patients a treatment option when other asparaginase products are no longer tolerable.
⚙️How it works▾
Pegaspargase is an enzyme — a protein that drives a chemical reaction in the body. It works by breaking down L-asparagine, an amino acid (a protein building block) found in the bloodstream. Leukemia cells have a low ability to make their own asparagine, so they depend on grabbing it from the blood to survive and grow. By rapidly depleting asparagine levels in plasma (blood) and cerebrospinal fluid (the fluid around the brain and spine), pegaspargase essentially cuts off leukemia cells' fuel supply, causing them to die. Normal cells, which can produce asparagine on their own, are largely able to compensate.
💊How it's taken▾
Oncaspar is always given by a healthcare team in a clinical setting — never at home. It can be injected into a muscle (intramuscular) or infused into a vein (intravenous), with the route chosen by your care team. It is given no more frequently than every 14 days as part of a broader chemotherapy schedule.
- Before each dose, patients receive pre-medications (such as acetaminophen and antihistamines) to reduce the risk of allergic reactions.
- After each dose, patients are monitored for at least 1 hour in the clinical setting.
- Blood tests (liver enzymes, bilirubin, blood sugar, and clotting levels) are checked at least weekly during treatment cycles.
- Follow your care team's schedule exactly; your oncologist will manage any missed or adjusted doses.
🤒Side effects — in detail▾
The most common serious side effects seen in clinical studies with Oncaspar include:
- Elevated liver enzymes (transaminases) — a sign of liver stress
- Low albumin (hypoalbuminemia) — a blood protein that can drop during treatment
- High blood sugar (hyperglycemia) — sometimes requiring insulin; may be lasting in some patients
- High triglycerides (hypertriglyceridemia) — elevated blood fats
- Increased bilirubin — can cause yellowing of skin or eyes
- Abnormal clotting studies — affecting the blood's ability to clot properly
- Febrile neutropenia — fever combined with very low infection-fighting white blood cells
- Allergic reactions — ranging from rash and hives to serious anaphylaxis
- Blood clots and embolic events
- Pancreatitis — inflammation of the pancreas
Seek immediate medical help for severe belly pain, difficulty breathing, signs of a blood clot, unusual bleeding, or sudden high fever — these are signs of potentially life-threatening complications that need urgent attention.
⚠️Warnings & precautions▾
- Anaphylaxis and serious allergic reactions: Can occur during or after each dose. Patients are pre-medicated and observed for 1 hour in a setting with emergency equipment. The risk is higher in patients with prior reactions to E. coli-derived asparaginase. Discontinue Oncaspar permanently for severe reactions.
- Pancreatitis: Inflammation of the pancreas — including hemorrhagic (bleeding) and necrotizing (tissue-destroying) forms — has been fatal. Watch for worsening belly pain and seek care immediately. If pancreatitis is confirmed, Oncaspar must not be restarted.
- Thrombosis (blood clots): Serious clots, including in brain blood vessels (sagittal sinus thrombosis), have occurred. Discontinue Oncaspar permanently for severe thrombotic events.
- Hepatotoxicity and veno-occlusive disease (VOD): Serious, potentially fatal liver damage — including VOD, where blood flow through the liver is blocked — has been reported. Signs include rapid weight gain, swelling, and rising bilirubin. Liver tests are monitored throughout treatment and for 6 weeks after the last dose.
- Hemorrhage (serious bleeding): Clotting abnormalities can lead to dangerous bleeding. Clotting factors are monitored; the drug may need to be stopped for severe bleeding.
- Glucose intolerance: Blood sugar can rise significantly; in some patients this may not fully reverse after treatment ends. Blood glucose is monitored regularly.
🔀What it interacts with▾
Oncaspar has a known interaction with at least one class of drugs commonly used alongside it in chemotherapy regimens:
- Glucocorticoids (e.g., dexamethasone): Pegaspargase may increase how much dexamethasone the body is exposed to, potentially raising the risk of glucocorticoid-related side effects — including osteonecrosis (bone damage, especially in joints like the hip).
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▾
- History of serious allergic reaction to Oncaspar or its ingredients: Do not use — this is a contraindication.
- History of serious blood clots with any prior asparaginase therapy: Do not use.
- History of pancreatitis, including from prior asparaginase treatment: Do not use.
- History of serious bleeding with prior asparaginase therapy: Do not use.
- Severe liver impairment: Do not use.
- Pregnancy: Oncaspar can harm a fetus. Pregnancy testing is recommended before starting treatment. Use effective non-hormonal contraception during treatment and for 3 months after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for 1 month after the last dose due to potential risk to the infant.
- Pediatric patients: Safety and effectiveness have been established in children; Oncaspar is commonly used in pediatric ALL treatment.
- Kidney or liver impairment (other than severe liver impairment): The effect of kidney or liver problems on how the body processes pegaspargase is not fully known; discuss your full medical history with your care team.
🚑If you take too much▾
In reported cases where patients received doses much higher than recommended, reactions included a mild rise in liver enzymes and, in one case, a rash that responded to antihistamine treatment and a slower infusion rate; one patient had no reaction at all. There is no specific antidote for a pegaspargase overdose. If too much is given, the healthcare team will monitor closely and treat any symptoms that arise with supportive care.
📡Pharmacodynamics — effects in the body▾
Oncaspar works by drastically lowering asparagine levels in the blood and spinal fluid. In clinical studies, asparagine in plasma was reduced below detectable levels for at least 11 days after a single dose during the induction phase of treatment. Levels in the cerebrospinal fluid (the fluid around the brain and spine) also dropped significantly within 4 days of dosing and stayed low for at least 25 days — important for reaching leukemia cells that may hide in the central nervous system.
🔬Pharmacokinetics — how your body processes it▾
After an intramuscular (IM) injection, pegaspargase is absorbed gradually, with peak enzyme activity reached around Day 5, and the drug remains active in the body for roughly 5–6 days on average (half-life of about 5.8 days). When given intravenously (IV), it reaches peak levels more quickly, with a similar half-life of about 5.3 days. Because of this long duration of action, doses are spaced at least 14 days apart. How kidney or liver disease affects the body's processing of this drug is not yet fully understood.
📦How to store it▾
Store ONCASPAR refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. stored at room temperature (15°C to 25°C ) for no more than 48 hours.
📄 Written from Pegaspargase 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 →
Supplements & herbs that interact with Pegaspargase Injection
17 supplements and herbal products have documented interactions with Pegaspargase Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pegaspargase Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Oncaspar treating, and why is it part of my chemotherapy? ▾
Why do I have to stay at the clinic for an hour after each dose? ▾
What side effects should I watch for at home and call about right away? ▾
I'm of childbearing age — what do I need to know about pregnancy during this treatment? ▾
I've had a bad reaction to asparaginase before — is Oncaspar safe for me? ▾
How will my doctors know if Oncaspar is affecting my liver or other organs? ▾
Is Pegaspargase Injection available over the counter? ▾
When was Pegaspargase Injection first available? ▾
💬 Answers drafted from Pegaspargase 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 Pegaspargase Injection comes
Pegaspargase 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
- Oncaspar is used as part of a multi-agent chemotherapy regimen for first-line treatment of acute lymphoblastic leukemia (ALL) in pediatric and adult patients
- Oncaspar is used as part of a multi-agent chemotherapy regimen for ALL in pediatric and adult patients who have had a hypersensitivity reaction to native L-asparaginase
- Oncaspar is given intramuscularly (into a muscle) or intravenously (into a vein) no more often than every 14 days
- When Oncaspar is given intramuscularly, the volume at any single injection site is limited to 2 mL; larger volumes require multiple injection sites
- When Oncaspar is given intravenously, it is diluted and infused over 1–2 hours through an already-running IV line; no other drugs should be infused through the same line at the same time
- Oncaspar must never be used if it has been frozen, left at room temperature for more than 48 hours, or shaken or vigorously agitated — discard the vial if any of those occurred
📊 Pegaspargase Injection across the U.S. market
How Pegaspargase 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.
🔍 Compare Pegaspargase Injection products
A representative set of FDA-listed product records for Pegaspargase 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 | ||||
| 750 [IU]/mL | Intramuscular, Intravenous | Servier Pharmaceuticals LLC | BLA | View NDC → |
| 750 [IU]/mL | Intramuscular; Intravenous | Servier Pharmaceuticals LLC × 2 listings | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Pegaspargase 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 Pegaspargase 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 Pegaspargase 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 Pegaspargase 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.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 34132 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1728058In current FDA listingsClinical drug / strength (SCD) 5 ML pegaspargase 750 UNT/MLRxCUI 240906
Look up RxCUI 34132 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pegaspargase 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
Pegaspargase 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. Servier Pharmaceuticals LLC 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.