- Acute myeloid leukemia
THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.
- Prepare in biohazard hood.
- CPX-351 is supplied as a preservative-free 50 mL vial that contains 44 mg of DAUNOrubicin and 100 mg of cytarabine.
- Store vials refrigerated at 5◦C (± 3◦C) in an upright position. Keep vial in original carton
- Allow vials to equilibrate to room temperature for 30 minutes prior to use.
- Reconstitute each vial with 19 mL of sterile water for injection.
- Carefully swirl the contents of the vial for 5 minutes, while gently inverting the vial every 30 seconds. Do NOT shake.
- After reconstitution, let rest for 15 minutes. The reconstituted product should be opaque, purple, homogenous dispersion.
- After reconstitution, each mL will contain 2.2 mg of DAUNOrubicin (and 5 mg of cytarabine).
- Gently invert each vial 5 times prior to withdrawing the reconstituted product for further dilution. If the reconstituted product is not diluted into an infusion bag immediately, it can be stored refrigerated at 2◦C to 8◦C for up to 4 hours.
- Further dilute with 0.9% NaCl to a final concentration of 0.044 to 0.58 mg of DAUNOrubicin/mL. Gently invert the bag to mix the solution. Do NOT shake. The final product will be a deep purple colour.
- Use the final diluted CPX-351 immediately after reconstitution. It may be stored refrigerated at 2◦C to 8◦C for up to 4 hours. If the reconstituted solution in the vial was stored for 4 hours at 2ºC to 8ºC, the diluted infusion solution must be used immediately and cannot be stored for an additional 4 hours. The reconstituted product in the vial and the reconstituted product which has been diluted into an infusion solution are stable for a total of 4 hours (not 4 hours each) when stored at 2ºC to 8ºC.
• The 4 hour stability period when reconstituted product diluted in the infusion bag is stored at 2°C to 8°C does not include the time required for reconstitution or the 90-minute infusion time
- Use the final diluted CPX-351 immediately after reconstitution. It may be stored refrigerated at 2◦C to 8◦C for up to 4 hours. If the reconstituted solution in the vial was stored for 4 hours at 2ºC to 8ºC, the diluted infusion solution must be used immediately and cannot be stored for an additional 4 hours. The reconstituted product in the vial and the reconstituted product which has been diluted into an infusion solution are stable for a total of 4 hours (not 4 hours each) when stored at 2ºC to 8ºC.
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Solutions Compatible: NS, D5W
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
Yes Usual dilution: 0.044-0.58 mg of DAUNOrubicin/mL Infusion Time: 90 minutes Flush the line after administration with NS or D5W. If diluted solution was refrigerated, gently invert the solution prior to administration |
| IV Continuous Infusion | NO |
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Please note: CPX-351 is dosed in terms of mg of DAUNOrubicin
50 to 60 mg/m2/dose of DAUNOrubicin
1.7 to 2 mg/kg/dose of DAUNOrubicin if BSA < 0.6 m2
CPX-351 is an investigational agent, so dosing may differ per protocol
- Infusion reactions are possible
- Myelosuppression, including neutropenia, thrombocytopenia, anemia, febrile neutropenia
- Nausea, vomiting, diarrhea/colitis, constipation, mucositis, decreased appetite, abdominal pain
- Rash, fever, chills, headache
- Visual impairment (photophobia, photosensitivity reaction, retinal tear, uveitis, blurred vision, reduced visual acuity, and vitreous floaters)
- Cough, dyspnea, chest pain, respiratory failure
- Hypotension, hypertension, arrhythmias, heart failure
- Insomnia, anxiety, dizziness, confusion, syncope
- Hyponatremia, hypokalemia, fluid overload, acute renal failure
- Bilirubin, ALT elevation
- Treatment of unusual side effects are available through the study chair identified on the front page of the protocol and/or pharmacy
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Have anaphylaxis kit at bedside.
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Due to the long half-life of CPX-351, time to recovery of neutrophils and platelets may be prolonged
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Each vial contains 100mg of copper gluconate, which corresponds to 14mg of elemental copper
- Children’s Oncology Group Protocol AAML1831 amendment 2B. Version date: 7 December 2021. Accessed 3June2022.