Pegaspargase
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From MedlinePlus, U.S. National Library of Medicine
Asparagine-specific Enzyme
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration Administer ONCASPAR in a healthcare setting with appropriate medical support and resuscitation equipment to manage hypersensitivity reactions, should they occur [see Warnings and Precautions ] . ONCASPAR is a clear and colorless solution. Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration.
If any of these are present, discard the vial. When ONCASPAR is administered intramuscularly: Limit the volume at a single injection site to 2 mL. If the volume to be administered is greater than 2 mL, use multiple injection sites. When ONCASPAR is administered intravenously: Dilute ONCASPAR with 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, using aseptic technique.
After dilution, administer immediately into a running infusion of either 0.9% Sodium Chloride, USP or 5% Dextrose Injection, USP, respectively. Administer over a period of 1-2 hours. Do not infuse other drugs through the same intravenous line during administration of ONCASPAR. The diluted solution should be used immediately.
If immediate use is not possible, the diluted solution should be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 48 hours. Protect infusion bags from direct sunlight. ONCASPAR does not contain a preservative. Use only one dose per vial; discard unused product.
| Adverse Reaction | SeverityGrade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening. | Action |
|---|---|---|
| Infusion Reaction/Hypersensitivity Reaction [see Warnings and Precautions (5.1)] | Grade 1 | Reduce the infusion rate by 50% |
| Grade 2 | Interrupt the infusion of ONCASPARTreat the symptomsWhen symptoms resolve, resume the infusion and reduce the infusion rate by 50% | |
| Grade 3 to 4 | Discontinue ONCASPAR permanently | |
| Thrombosis [see Warnings and Precautions (5.2)] | Uncomplicated deep vein thrombosis | Hold ONCASPARTreat with appropriate antithrombotic therapyUpon resolution of symptoms consider resuming ONCASPAR, while continuing antithrombotic therapy |
| Severe or life-threatening thrombosis | Discontinue ONCASPAR permanentlyTreat with appropriate antithrombotic therapy | |
| Pancreatitis [see Warnings and Precautions (5.3)] | Grades 3 to 4 | Hold ONCASPAR for elevations in lipase or amylase >3 × ULN until enzyme levels stabilize or are decliningDiscontinue ONCASPAR permanently if clinical pancreatitis is confirmed |
| Hemorrhage [see Warnings and Precautions (5.5)] | Grade 3 to 4 | Hold ONCASPAREvaluate for coagulopathy and consider clotting factor replacement as neededResume ONCASPAR with the next scheduled dose if bleeding is controlled |
| Hepatotoxicity [see Warnings and Precautions (5.6)] | Total bilirubin more than 3 times to no more than 10 times the ULN | Hold ONCASPAR until total bilirubin is ≤1.5 times the ULN |
| Total bilirubin more than 10 times the ULN | Discontinue ONCASPAR and do not make up for missed doses |
Drug interactions
Check pegaspargase against a medication listLabel text (2 paragraphs)
7 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) ] .
Contraindications
4 CONTRAINDICATIONS ONCASPAR is contraindicated in patients with a: History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see Warnings and Precautions (5.1) ] . History of serious thrombosis with prior L-asparaginase therapy [see Warnings and Precautions (5.2) ] . History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy [see Warnings and Precautions (5.3) ] . History of serious hemorrhagic events with prior L-asparaginase therapy [see Warnings and Precautions (5.5) ] . Severe hepatic impairment [see Warnings and Precautions (5.6) ] . History of serious hypersensitivity reactions to ONCASPAR.
( 4 ) History of serious thrombosis with prior L-asparaginase therapy. ( 4 ) History of pancreatitis with prior L-asparaginase therapy. ( 4 ) History of serious hemorrhagic events with prior L-asparaginase therapy. ( 4 ) Severe hepatic impairment. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for pegaspargase. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk summary Based on published literature studies with L-asparaginase in pregnant animals, ONCASPAR can cause fetal harm when administered to a pregnant woman. There are no available data on ONCASPAR use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see Data ) . Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with ONCASPAR to evaluate its effect on reproduction and fetal development. Published literature studies in which pregnant rabbits were administered L-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring.
Breastfeeding (LactMed)
No information is available on the clinical use of pegaspargase during breastfeeding. Because pegaspargase is a large protein molecule with a molecular weight of about 140,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Polyethylene glycol is not excreted into breastmilk. However, the manufacturer recommends that the drug not be used during breastfeeding and for 1 month after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.