Safety profile

Adverse reactions in ≥5% patients in any treatment group in Study DFCI 11-001^1§

	ASPARLAS^® 2500 IU/m² (All Grades) (N=118)	ONCASPAR^® 2500 IU/m² (All Grades) (N=119)	ASPARLAS^® 2500 IU/m² (≥Grade 3) (N=118)	ONCASPAR^® 2500 IU/m² (≥Grade 3) (N=119)
Blood and lymphatic system disorders
Febrile neutropenia	33.9%	40.3%	33.9%	40.3%
Gastrointestinal disorders
Stomatitis	25.4%	20.2%	25.4%	20.2%
Pancreatitis	11.9%	16.8%	10.2%	11.8%
Neutropenic colitis	6.8%	2.5%	6.8%	2.5%
Immune system disorders
Hypersensitivity	9.3%	5.9%	5.1%	3.4%
Drug hypersensitivity	5.1%	5.9%	0.8%	1.7%
Infections and infestations
Staphylococcal infection	5.9%	3.4%	5.9%	3.4%
Sepsis	5.1%	5.0%	5.1%	5.0%
Investigations
ALT increased	78.8%	77.3%	49.2%	60.5%
AST increased	53.4%	58.8%	26.3%	30.3%
Blood bilirubin increased	45.8%	43.7%	17.8%	17.6%
Bilirubin conjugated increased	22.0%	31.9%	8.5%	13.4%
Blood fibrinogen decreased	22.0%	26.9%	12.7%	17.6%
Amylase increased	17.8%	18.5%	11.0%	12.6%
Lipase increased	16.9%	24.4%	15.3%	21.0%
aPTT prolonged	11.9%	15.1%	5.9%	6.7%
INR increased	11.9%	5.9%	3.4%	0.8%
Blood ALP increased	8.5%	6.7%	3.4%	0.8%
Blood culture positive	5.1%	5.0%	5.1%	5.0%
Metabolism and nutrition disorders
Hypoalbuminemia	81.4%	82.4%	27.1%	27.7%
Hypokalemia	45.8%	39.5%	43.2%	36.1%
Hyperglycemia	33.9%	28.6%	23.7%	24.4%
Hypoglycemia	30.5%	36.1%	6.8%	11.8%
Hypertriglyceridemia	28.0%	36.1%	21.2%	30.3%
Hyponatraemia	22.0%	22.7%	19.5%	19.3%
Hyperkalaemia	7.6%	16.0%	0.8%	1.7%
Nervous system disorders
Seizure	5.1%	1.7%	0	0.8%
Vascular disorders
Hypertension	5.1%	11.8%	3.4%	5.9%

§ 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.

Safety profile

Adverse reactions in ≥5% patients in any treatment group in Study DFCI 11-0011§

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Adverse reactions in ≥5% patients in any treatment group in Study DFCI 11-001^1§