Hypersensitivity and infusion-related reactions
Measures to decrease the risk of hypersensitivity and infusion-related reactions with ONCASPAR® treatment1
Premedication
- Premedicate patients with acetaminophen, an H-1 receptor blocker (e.g., diphenhydramine), and an H-2 receptor blocker (e.g., famotidine) 30-60 minutes prior to administration of ONCASPAR® to decrease the risk and severity of both infusion and hypersensitivity reactions.
- Steroid administration may also be considered in the premedication regimen.
- If premedication is administered, therapeutic drug monitoring should be considered to assess for silent inactivation.
Managing infusion or hypersensitivity reactions
- Mild (Grade 1): Reduce the infusion rate by 50%
- Moderate (Grade 2): Interrupt the infusion of ONCASPAR® and treat symptoms. When symptoms resolve, resume the infusion and reduce the infusion rate by 50%
- Severe (Grade 3 to 4): Discontinue ONCASPAR® permanently
Therapeutic drug monitoring
- If premedication is administered, therapeutic drug monitoring should be considered to assess for silent inactivation.
- Treatment may be monitored based on the trough serum L-asparaginase activity measured before the next administration of ONCASPAR®.
- If L-asparaginase activity values fail to reach target levels, a switch to a different L-asparaginase preparation could be considered
Please consult the ONCASPAR® Product Monograph for full recommendations on reducing hypersensitivity risk.
aBFM: augmented Berlin-Frankfurt-Münster; ALL: acute lymphoblastic leukemia; BSA: body surface area; CNS: central nervous system; CSF: cerebrospinal fluid; DFCI: Dana-Farber Cancer Institute; ELISA: enzyme-linked immunosorbent assay; IM: intramuscular; IV: intravenous; PD: pharmacodynamics; PK: pharmacokinetics; NCCN: National Comprehensive Cancer Network®; TDM: therapeutic drug monitoring.
* Clinical significance has not been established.
† Comparative clinical significance has not been established.
‡ Fictitious cases. May not be representative of all patients.
§ Native E. coli L-asparaginase is not available in Canada.
References:
- ONCASPAR® Product Monograph. Servier Canada. August 20, 2024.
- ONCASPAR_CPID Redacted.
- ASPARLAS® Product Monograph. Servier Canada. March 8, 2024.
- RYLAZE™ Product Monograph. Jazz Pharmaceuticals Canada Inc.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed November 8, 2024.
- 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.
