Servier Canada
Asparlas®
ASPARLAS logo; ASPARLAS calaspargase pegol for injection

Hypersensitivity and infusion-related reactions

CTCAE 4.0 grading for hypersensitivity reactions11

Adverse event

Grade 1

Allergic reaction

Transient flushing or rash, drug fever <38 degrees C (<100.4 degrees F); intervention not indicated

Anaphylaxis

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Adapted from the National Institutes of Health.

Definitions:11

  • Allergic reaction: A disorder characterized by an adverse local or general response from exposure to an allergen.
  • Anaphylaxis: A disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis, and loss of consciousness, and may lead to death.

Mitigating, identifying, and managing hypersensitivity with ASPARLAS®1

Premedication prior to administration
Premedicate patients with acetaminophen, an H-1 receptor blocker and an H-2 receptor blocker 30-60 minutes prior to administration of ASPARLAS® to decrease the risk and severity of both infusion and hypersensitivity reactions. Steroid administration may also be considered in the premedication regimen.

Grade 1
  • Reduce infusion rate by 50%
Grade 2
  • Interrupt the infusion
  • Treat the symptoms
  • When symptoms resolve, resume the infusion and reduce the infusion rate by 50%
Grade 3 or 4
  • Discontinue ASPARLAS® permanently

Please consult the ASPARLAS® Product Monograph for full guidance on responding to hypersensitivity reactions.

Learn more about ASPARLAS®

aBFM: augmented Berlin-Frankfurt-Münster; AE: adverse event; ALL: acute lymphoblastic leukemia; ALP: alkaline phosphatase; ALT: alanine aminotransferase; aPTT: activated partial thromboplastin time; AST: aspartate aminotransferase; BFM: Berlin-Frankfurt-Munster; BSA: body surface area; CSF: cerebrospinal fluid; CTCAE: Common Terminology Criteria for Adverse Events; DFCI: Dana-Farber Cancer Institute; IM: intramuscular; IV: intravenous; NCCN: National Comprehensive Cancer Network®; NPAA: nadir plasma arparaginase activity; NSAA: nadir serum asparaginase activity; NSAID: non-steroidal anti-inflammatory drug; PD: pharmacodynamics; PK: pharmacokinetics; TDM: therapeutic drug monitoring.

* Comparative clinical significance has not been established.

† Fictitious cases. May not be representative of all patients.

‡ Clinical significance has not been established.

References: 

  1. ASPARLAS® Product Monograph. Servier Canada.
  2. Data on file. Servier Canada.
  3. ONCASPAR® Product Monograph. Servier Canada.
  4. RYLAZE™ Product Monograph. Jazz Pharmaceuticals Canada Inc.
  5. Government of Canada. Summary Basis of Decision for Asparlas. Available at https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396.
  6. Government of Canada. ONCASPAR_CPID Redacted.
  7. Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J. 2017;7(6):e577.
  8. Mank V, Azhar W, Brown K. Leukocytosis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; April 21, 2024.
  9. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Acute Lymphoblastic Leukemia, version 4.2023 – February 05, 2024.
  10. Vrooman LM et al. Efficacy and toxicity of pegaspargase and calaspargase pegol in childhood acute lymphoblastic leukemia: Results of DFCI 11-001. J Clin Oncol. 2021;39(31):3496–3505.
  11. National Institutes of Health. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE): Version 4.0. Available at: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5×11.pdf. Accessed December 11, 2024.
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