Dosing and Monitoring

A nurse administers IV treatment to an acute lymphoblastic leukemia patient.

Recommended dose1

For patients aged 22 years and older, the recommended ONCASPAR dose is 2000 IU/m2 given intramuscularly or intravenously no more than every 14 days.

IV bag for intravenous administration of ONCASPAR

When given intravenously

  • Administer over a period of 1 to 2 hours
  • Administer into an infusion line that is already running
  • Do not infuse other drugs through the same intravenous line during administration of ONCASPAR
syringe for intermuscularly injection of ONCASPAR

When given 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

Administer ONCASPAR in a healthcare setting with appropriate medical support and resuscitation equipment to manage hypersensitivity reactions, should they occur.


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.

Preparing ONCASPAR for IV administration

  • 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

  • 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

Premedication

A proven asparaginase therapy.

A safer way to administer with premedication

Take measures to prevent or limit the severity of hypersensitivity and infusion reactions by

Pill Bottle

Premedicating with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of ONCASPAR1

Clock

Slowing the infusion rate to ≥2 hours2,3

IV bag

Infusing normal saline concurrently2,3

Therapeutic Drug Monitoring (TDM)

TDM helps you make informed treatment decisions

TDM measures serum asparaginase activity levels, helping clinicians distinguish between true allergic reactions, nonallergic infusion reactions, and hyperammonemia to determine when switching asparaginase formulations may be warranted.4,5

Not All Reactions Are Created Equal

Some patients treated with asparaginase may have the following responses:

Nonallergic Reactions

Infusion Reaction

Non–antibody mediated6

When misdiagnosed as an allergic reaction, can lead to unnecessary contraindication to and switching or discontinuation of asparaginase treatment4,7

Premedication can reduce the risk of nonallergic reactions2,3

Hyperammonemia

Non–antibody mediated, results from spikes in serum ammonia levels4

If misdiagnosed as an allergic reaction, can lead to unnecessary contraindication to and switching or discontinuation of asparaginase treatment4,7

TDM can help distinguish between allergic reactions and hyperammonemia4

Allergic Reactions

Allergic Reaction

(Hypersensitivity)

Antibody mediated; antibodies inactivate asparaginase, reducing asparaginase activity4,6,8

Nonallergic reactions usually cannot be distinguished from allergic reactions based on clinical symptoms or grade2,4,9

TDM can help distinguish between allergic and nonallergic reactions4

Silent Inactivation

(Subclinical Hypersensitivity)

Patients develop anti-asparaginase antibodies without clinical signs of hypersensitivity4

If unrecognized, patients are often continued on the same asparaginase formulation with no therapeutic benefit4

TDM will help to establish whether a patient has silent inactivation4

For more information about available assay testing or to order a test measuring asparaginase activity level, please contact one of the laboratories listed below.

Quest Diagnostics
(Granger Genetics)

1-866-MYQUEST questdiagnostics.com 844-347-2643 grangergenetics.com info@grangergenetics.com

Next Molecular Analytics

844-812-7415 nextmolecular.com info@nextmolecular.com

Staying on Asparaginase

Studies show a significant drop in ALL survival when asparaginase is discontinued from treatment regimens

Lower Disease-Free Survival (DFS) When Asparaginase Is Discontinued10
DFS

Studies: Children's Oncology Group (COG) AALL0331 and COG AALL0232

Patients (combined): 8386 patients
aged 1 to 30 years.

There was a 50% decrease in the likelihood of DFS in high-risk and standard-risk patients with slow early response who discontinued asparaginase treatment.

Higher 5-Year Event-Free Survival (EFS) With 26+ Weeks of Treatment11
5-year EFS rate

Study: Dana-Farber Cancer Institute 91-01

Patients: 377 patients aged 0 to 18 years experienced 90% ± 2% 5-year EFS when receiving asparaginase for at least 26 weeks compared with 73% ± 7% 5-year EFS in those receiving fewer than 25 weeks of asparaginase.

TDM and premedication can help your patients stay on ONCASPAR

Marini and colleagues reported on a center that reduced the rate of switching from ONCASPAR to Erwinia-based asparaginase from 21% without premedication to 7% with premedication and TDM12

Another Center Showed That Premedication and TDM Reduced the Risk of Drug Substitution and the Rate of Clinical Reactions to ONCASPAR (Cooper, 2019)13
A chart showing a reduction in drug substitutions from 17.2% to 7.4%

57% Reduction in Substitutions

Before a policy of TDM and premedication was implemented, 21 of 122 patients (17.2%) were switched to asparaginase Erwinia chrysanthemi (Erwinia) compared with 5 of 68 patients (7.4%) after policy implementation (P=0.028)

A chart showing a reduction in adverse events from 17.2% to 5.9%

66% Reduction in Adverse Events

Before policy implementation, 21 of 122 patients (17.2%) had clinically significant reactions compared with 4 of 68 patients (5.9%) after policy (P=0.017)

Zero grade 4 adverse events or intensive care unit admissions with premedication vs 15% without premedication13

Study design: A retrospective chart review compared the rate of adverse events among patients receiving IV ONCASPAR and the rate of switching to Erwinia before and after implementation of a policy of universal premedication and TDM. Efficacy was assessed using a serum asparaginase activity assay that was performed 1 week after IV ONCASPAR administration. Of these patients, 109 were treated prior to the implementation of the universal premedication policy and 55 were treated following implementation. An additional 13 patients received ONCASPAR, both without and with premedication, and were therefore included in both groups.13

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION Section

CONTRAINDICATIONS

  • History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR (pegaspargase) or to any of the excipients.
  • History of serious thrombosis with prior L-asparaginase therapy.
  • History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy.
  • History of serious hemorrhagic events with prior L-asparaginase therapy.
  • Severe hepatic impairment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR (pegaspargase) or to any of the excipients.
  • History of serious thrombosis with prior L-asparaginase therapy.
  • History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy.
  • History of serious hemorrhagic events with prior L-asparaginase therapy.
  • Severe hepatic impairment.

WARNINGS and PRECAUTIONS 

Anaphylaxis and Serious Hypersensitivity Reactions: Anaphylaxis and serious hypersensitivity reactions can occur. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to (E.) coli derived L-asparaginase formulations. Premedicate patients 30-60 minutes prior to administration of ONCASPAR. Observe patients for 1 hour after administration in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Discontinue ONCASPAR in patients with serious hypersensitivity reactions.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, can occur. Discontinue ONCASPAR in patients with serious thrombotic events.

Pancreatitis: Pancreatitis can occur. Fatal outcomes have been reported. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR. 

Glucose Intolerance: Glucose intolerance can occur and, in some cases, be irreversible. Monitor serum glucose. 

Hemorrhage: Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia can occur. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy. Discontinue ONCASPAR for severe or life-threatening hemorrhage. 

Hepatotoxicity: Hepatotoxicity and abnormal liver function can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment through at least 6 weeks after the last dose. In the event of serious liver toxicity, discontinue ONCASPAR and provide supportive care.

ADVERSE REACTIONS

The most common grade 3 and 4 adverse reactions with ONCASPAR (>5%) included hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. 

INDICATIONS AND USAGE

ONCASPAR® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with:

  • First-line acute lymphoblastic leukemia (ALL)
  • ALL and hypersensitivity to native forms of L-asparaginase
Please see Full Prescribing Information.