Parenteral Manual

CPX-351 (DAUNOrubicin & Cytarabine liposome) (Study supply; NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Vyxeos
Classification: 
Antineoplastic antimetabolite & antibiotic (anthracycline) - CYTOTOXIC
Original Date: 
December 2020
Indications: 
  • 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.

Reconstitution and Stability: 
  • 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.
  • 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.
Compatibility: 
  • Solutions Compatible: NS, D5W

Administration: 

(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

Do NOT administer through an in-line filter.

Flush the line after administration with NS or D5W.

IV Continuous Infusion NO

 

Dosage: 

(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

Potential hazards of parenteral administration: 
  • 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
  • Hypotension, hypertension, arrhythmias

- Treatment of unusual side effects are available through the study chair identified on the front page of the protocol and/or pharmacy

Notes: 
  • Have anaphylaxis kit at bedside.

  • Due to the long half-life of CPX-351, time to recovery of neutrophils and platelets may be prolonged

References: 
  • Children’s Oncology Group Protocol AAML1831. Version date: 28Feb2020. Accessed 30Nov2020.

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