Servier Canada
Oncaspar®
ONCASPAR logo; ONCASPAR pegaspargase injection.

Safety profile

Adverse reactions (all grades) reported with ONCASPAR® therapy1

MedDRA Standard System Organ Class

Very common (≥1 in 10)

Blood and lymphatic system disorders

Febrile neutropenia

Gastrointestinal disorders

Pancreatitis, Diarrhea, Abdominal pain

Hepatobiliary disorders

Immune system disorders

Hypersensitivity, Urticaria, Rash, Anaphylactic reactions

Infections and infestations

Infections

Investigations

Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood fibrinogen decreased, Lipase increased, International normalized ratio increased, Amylase increased, Activated partial thromboplastin time prolonged

Metabolism and nutrition disorders

Hyperglycemia, Hypertriglyceridemia, Hypoalbuminemia

Musculoskeletal and connective tissue disorders

Nervous system disorders

Respiratory, thoracic and mediastinal disorders

Vascular disorders

Embolism

Adapted from the ONCASPAR® Product Monograph. Please see the ONCASPAR® Product Monograph for full safety information.

¶ The following were observed in clinical trial DFCI 11-001: Pulmonary embolism (common), venous thrombosis (common), venous thrombosis limb (uncommon), thrombophlebitis superficial (uncommon).

|| Including CNS Thrombosis.

Investigations reported as adverse events:1

  • Very common: ALT increased, AST increased, blood bilirubin increased, blood fibrinogen decreased, lipase increased, international normalized ratio increased, amylase increased, activated partial thromboplastin time prolonged.
  • Common: Neutrophil count decreased, platelet count decreased.

In patients with previously treated ALL and/or hypersensitivity to native E. coli asparaginase1

Adverse reaction information was obtained from clinical trials that enrolled a total of 174 patients with relapsed ALL who received ONCASPAR® as a single agent or in combination with multi-agent chemotherapy. In this group:

  • The most common adverse reactions of ONCASPAR® were clinical allergic reactions (bronchospasm, hypotension, laryngeal edema, local erythema or swelling, systemic rash, and urticaria), elevated transaminases, hyperbilirubinaemia, and coagulopathies.
  • The most common serious adverse events due to ONCASPAR® treatment were thrombosis (4%), hyperglycaemia requiring insulin therapy (3%), and pancreatitis (1%).

Immunogenicity1

As with all therapeutic proteins, with ONCASPAR® there is a potential for immunogenicity, defined as development of binding and/or neutralizing antibodies to the product.

In Study CCG-1962, ONCASPAR®-treated patients were assessed for evidence of binding antibodies using an enzyme-linked immunosorbent assay (ELISA) method. The incidence of protocol-specified “high-titer” antibody formation was 2% in Induction (n=48), 10% in Delayed Intensification 1 (n=50), and 11% in Delayed Intensification 2 (n=44).

There is insufficient information to determine whether the development of antibodies is associated with an increased risk of clinical allergic reactions, altered pharmacokinetics, or loss of anti-leukemic efficacy.

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: 

  1. ONCASPAR® Product Monograph. Servier Canada. August 20, 2024.
  2. ONCASPAR_CPID Redacted.
  3. ASPARLAS® Product Monograph. Servier Canada. March 8, 2024.
  4. RYLAZE™ Product Monograph. Jazz Pharmaceuticals Canada Inc.
  5. 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.
  6. 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.
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