- Component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia
- Acute myeloid leukemia (off label)
Refrigerate. Do NOT freeze
- Available as a clear solution in a 5 mL vial containing 750 units/mL
- Single use vial. Preservative free.
- Dilute in 100 mL of 0.9% NaCl. Diluted solution should be stored refrigerated (2 - 8 degrees celcius). Storage of diluted solution should not exceed 48 hours from time of preparation to completion of administration
- Reconstitute vial with 1 mL 0.9% NaCl to give a 10 000 unit/mL concentration. Preservative free.
- Caution: vigorous shaking may result in loss of potency. To mix, direct 0.9% NaCl to the side of the vial, then gently rotate the vial.
- Withdraw from vial within 15 minutes of reconstitution. Filter needle must be used.
- Stable in syringe or a minibag at room temperature for 4 hours
- Do not refrigerate syringe
Recombinant Crisantaspase Pseudomonas Fluorescens (RC-P)
- Available as a clear to opalescent, slightly yellow solution in a 0.5 mL single use vial containing 10 mg of recombinant crisantaspase
- Store unopened vials in the fridge, in its supplied carton. Protect vials from light. Let vials sit at room temperature for 5-10 minutes prior to dose preparation
- Do NOT shake. Gently swirl vials.
- For IV administration: Dilute in 100 mL of 0.9% NaCl (Latex free, PVC free, DEHP free bag). Final product stable 4 hours at room temperature and does not need to be protected from light. Initiation of the fully diluted recombinant crisantaspase must be started within 2 hours of preparation. Administration should be completed within 4 hours of preparation.
- For AALL1931: Only ONE lot number should be used for each dose. More than one lot number can be used for each course.
- Solutions Compatible:
- Pegaspargase: D5W, 0.9% NaCl
- Erwinia-L-asparaginase: 0.9% NaCl
- Recombinant Crisantaspase (RC-P): 0.9% NaCl
- DO NOT mix with other drugs
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
Erwinia-L-asparaginase: YES, inject into a large muscle
Recombinant Crisantaspase (RC-P): YES, inject into a large muscle
|IV Intermittent Infusion||
Pegaspargase : YES, in 100 mL of 0.9% NaCl or D5W over 1-2 hours
Recombinant Crisantapase (RC-P): YES, in 100mL 0.9NaCl over 2 hours. Non-PVC bags and DEPH-free tubing must be used
|IV Continuous Infusion||NO|
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- 2500 units/m2/dose as part of a comboination chemotherapy regimen; do not administer more frequently than every 14 days
- 25 000 units/m2 , 3 times per week x 6 doses to replace each dose of pegaspargase
- Dosage may differ according to protocol
Recombinant Crisantaspase (RC-P):
Expected Investigational starting dosing:
- 25 mg/m2 IM 3 times per week x 6 doses to replace each dose of Pegaspargase
- 37.5 mg/m2 IV 3 times per week x 6 doses to replace each dose of Pegaspargase
- Refer to protocol for patient specific cohort dosing
Immediate (within a few minutes to hours)
- Anaphylaxis, other allergic reactions (6-43%) - urticaria, pruritus, respiratory distress, hypotension, chills, fever)
- Nausea and vomiting rare - more common with initial doses
- Pain/bruising at injection site (IM administration) - hold site at least 5 minutes after injection or until bleeding stops. Apply ice if platelet counts low.
Delayed (within a few days to weeks)
- Hemorrhagic and thrombotic cardiovascular events - decreased fibrinogen, clotting factors, antithrombin
- Hepatotoxicity - hypoalbuminemia, increased transaminases
- Hyperglycemia - monitor urine/blood glucose; hypoglycemia possible
- Pancreatitis - elevated serum amylase, assess for abdominal tenderness
- Have anaphylaxis kit at bedside. Out-patients should remain in the clinic for at least one hour following injection. NOTE: anaphylaxis may be delayed following IM injection.
- Insulin may be required for severe hyperglycemia.
- Pegaspargase is contraindicated with a history of severe pancreatitis with any prior asparaginase therapy, serious thrombosis with any prior asparaginase therapy, or serious hemorrhagic events with any prior asparaginase therapy.
- Pegaspargase may affect coagulation factors and predispose to bleeding and/or thrombosis. Caution should be used when administering any concurrent anticoagulant therapy
- Give asparaginase AFTER methotrexate, cytarabine and vincristine NOT BEFORE
- Erwinase Product Monograph (EUSA/Jazz Canada)
- Erwinase Product Monograph (Jazz-USA)
- COG Memo January 2, 2015 - Approval of IV route of Erwinia asparaginase
- Recombinant Crisantaspase Pseudomonas Fluorescens (RC-P) Pharmacy Manual (Jazz-USA) version 6.0 Version Date 10 Nov 2020
- Oncaspar – Pegaspargase Product Monograph. Servier Canada. Version 21 Jan 2021.
- Erwinia and Pegaspargase. Children’s Oncology Group. Parenteral and oral Chemotherapy Administration Guidelines used by the Children’s Oncology Group. Version 10.1 Version Date: 05/01/2020
- Erwinase Product Monograph (Jazz Pharmaceuticals France). Version 30 Aug 2016 (access 23 Feb2021 via HC product database website)
- Investigator’s Brochure for Recombinant Crisantaspase produced in Pseudomonas fluorescens. Version 3.0. Version date 20 Jan 2021