Miscellaneous antineoplastics
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Oncaspar Dosage

Drug Detail:Oncaspar (Pegaspargase [ peg-ah-spar-jase ])

Generic Name: PEGASPARGASE 750[iU] in 1mL

Dosage Form: injection, solution

Drug Class: Miscellaneous antineoplastics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage

Patients 21 Years of Age or Younger

The recommended dose of ONCASPAR for patients up to and including 21 years of age is 2,500 International Units/m2 intramuscularly or intravenously no more frequently than every 14 days.

Patients More Than 21 Years of Age

The recommended dose of ONCASPAR for adult patients more than 21 years of age is 2,000 International Units/m2 intramuscularly or intravenously no more frequently than every 14 days.

Recommended Premedication

Premedicate patients 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 ONCASPAR to decrease the risk and severity of both infusion and hypersensitivity reactions [see Warnings and Precautions (5.1)].

Recommended Monitoring and Dosage Modifications for Adverse Reactions

Monitor patients at least weekly, with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1.

Table 1. Dosage Modifications
Adverse Reaction Severity* Action
*
Grade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening.
Infusion Reaction/Hypersensitivity Reaction [see Warnings and Precautions (5.1)] Grade 1
  • Reduce the infusion rate by 50%
Grade 2
  • Interrupt the infusion of ONCASPAR
  • Treat the symptoms
  • When 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 ONCASPAR
  • Treat with appropriate antithrombotic therapy
  • Upon resolution of symptoms consider resuming ONCASPAR, while continuing antithrombotic therapy
Severe or life-threatening thrombosis
  • Discontinue ONCASPAR permanently
  • Treat 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 declining
  • Discontinue ONCASPAR permanently if clinical pancreatitis is confirmed
Hemorrhage [see Warnings and Precautions (5.5)] Grade 3 to 4
  • Hold ONCASPAR
  • Evaluate for coagulopathy and consider clotting factor replacement as needed
  • Resume 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

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 (5.1)].

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.

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