Indications: Acute Lymphoblastic Leukemia (in combination with other chemotherapy) in patients with hypersensitivity to E. coli-derived asparagines.

Cautions: since its given intramuscularly, intravenously, or subcutaneously almost exclusively in acute lymphoblastic leukaemia. Facilities for the management of anaphylaxis should be available.

Contra-indications: History of serious hypersensitivity reactions, including anaphylaxis to asparaginase or any component of the formulation. history of serious pancreatitis, serious thrombosis, or serious hemorrhagic event with prior asparaginase treatment.

Pregnancy: Most cytotoxic drugs are teratogenic and should not be administered during pregnancy, especially during the first trimester. Exclude pregnancy before treatment with cytotoxic drugs. Considerable caution is necessary if a pregnant woman presents with cancer requiring chemotherapy, and specialist advice should always be sought. (Use during pregnancy only if clearly needed).

Breast-feeding: discontinue breast-feeding

Renal Impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Hepatic Impairment There are no dosage adjustments provided in the manufacturer’s labeling.

Pancreatitis: Pancreatitis reported during clinical trials: Discontinue drug for severe or hemorrhagic pancreatitis manifested by abdominal pain >72 hr and amylase elevation 2.0 x ULN or more. Mild pancreatitis: hold drug until signs and symptoms subside, and amylase levels return to normal; after resolution, treatment may resume.

Side Effects: Most common: Hypersensitivity: Hypersensitivity reaction (includes anaphylaxis, urticaria) Less common: Cardiovascular: Thrombosis. Endocrine & metabolic: Decreased glucose tolerance, hyperglycemia. Gastrointestinal: Pancreatitis, nausea, vomiting, abdominal pain, diarrhea. Hepatic: Abnormal transaminase, hyperbilirubinemia. Local: Injection site reaction. Miscellaneous: Fever. Rare: (Limited to important or life-threatening): Acute renal failure, anorexia, bone marrow depression (very rare), changes in serum lipids, disseminated intravascular coagulation, hemorrhage, hepatomegaly, hyperammonemia, increased alkaline phosphatase, malabsorption syndrome, seizure, transient ischemic attacks, weight loss.

Dose: Adult Acute lymphoblastic leukemia (ALL): IM: As a substitute for pegaspargase: 25, 000 units/m2 3 times weekly (Mon, Wed, Fri) for 6 doses for each planned pegaspargase dose. As a substitute for asparaginase (E. coli): 25, 000 units/m2 for each planned asparaginase (E. coli) dose ALL induction: Canadian labeling (not in the U.S. labeling): SubQ: 10, 000 units/m2 days 1, 3, and 5 of week 4 and day 1 of week 5 (in combination with prednisolone, vincristine, mercaptopurine, and methotrexate) or 10, 000 units/m2 3 times weekly (starting week 4) for 4 weeks (in combination with prednisolone, vincristine, and daunorubicin).

Acute lymphoblastic leukemia (ALL): IM: Refer to adult dosing. ALL induction: Canadian labeling (not in the U.S. labeling): Children <14 years: IM: 6000 units/m2 3 times weekly for 9 doses beginning day 4 of week 1 (in combination with vincristine, prednisone, methotrexate, and daunorubicin). Children >14 years:

SubQ: Refer to adult dosing