Safety profile
Adverse reactions in ≥5% patients in any treatment group in Study DFCI 11-0011§
ASPARLAS® | ||||
|---|---|---|---|---|
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 33.9% | |||
Gastrointestinal disorders | ||||
Stomatitis | 25.4% | |||
Pancreatitis | 11.9% | |||
Neutropenic colitis | 6.8% | |||
Immune system disorders | ||||
Hypersensitivity | 9.3% | |||
Drug hypersensitivity | 5.1% | |||
Infections and infestations | ||||
Staphylococcal infection | 5.9% | |||
Sepsis | 5.1% | |||
Investigations | ||||
ALT increased | 78.8% | |||
AST increased | 53.4% | |||
Blood bilirubin increased | 45.8% | |||
Bilirubin conjugated increased | 22.0% | |||
Blood fibrinogen decreased | 22.0% | |||
Amylase increased | 17.8% | |||
Lipase increased | 16.9% | |||
aPTT prolonged | 11.9% | |||
INR increased | 11.9% | |||
Blood ALP increased | 8.5% | |||
Blood culture positive | 5.1% | |||
Metabolism and nutrition disorders | ||||
Hypoalbuminemia | 81.4% | |||
Hypokalemia | 45.8% | |||
Hyperglycemia | 33.9% | |||
Hypoglycemia | 30.5% | |||
Hypertriglyceridemia | 28.0% | |||
Hyponatraemia | 22.0% | |||
Hyperkalaemia | 7.6% | |||
Nervous system disorders | ||||
Seizure | 5.1% | |||
Vascular disorders | ||||
Hypertension | 5.1% | |||
§ Adverse reactions are based on treatment-emergent adverse events observed with ASPARLAS® as a component of multi-agent combination chemotherapy regardless of causal relationship.
Adapted from the ASPARLAS® Product Monograph. Please consult the ASPARLAS® Product Monograph for full safety information.
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:
- ASPARLAS® Product Monograph. Servier Canada.
- Data on file. Servier Canada.
- ONCASPAR® Product Monograph. Servier Canada.
- RYLAZE™ Product Monograph. Jazz Pharmaceuticals Canada Inc.
- Government of Canada. Summary Basis of Decision for Asparlas. Available at https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718207489396.
- Government of Canada. ONCASPAR_CPID Redacted.
- Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J. 2017;7(6):e577.
- Mank V, Azhar W, Brown K. Leukocytosis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; April 21, 2024.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Acute Lymphoblastic Leukemia, version 4.2023 – February 05, 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.
- 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.
Stay Connected with Servier Canada
Stay up to date on disease information, treatment options, our products, and patient support programs.