BlackBoxRX
 
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Daunorubicin (Liposomal)


Cardiotoxicity; Myelosuppression; Infusion Reaction

Cardiotoxicity

  • Cardiac function should be monitored regularly in patients receiving liposomal daunorubicin because of the potential risk for cardiac toxicity and CHF.
  • Cardiac monitoring is advised, especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart.
  • Dosage should be reduced in patients with impaired hepatic function.

Myelosupprression

  • Severe myelosuppression may occur

Prescribing

  • This agent should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapy.

Infusion Reaction

  • A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with this agent in phase III trials, and in 2.7% of treatment cycles (27/994). This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Careful hematological monitoring
  • Evaluate Cardiac function at baseline, before each course, at 320 mg/m2 cumulative dose and every 160 mg/m2 dose thereafter. Risk of cardiac toxicity increased with prior anthracycline use, pre-existing cardiac disease, or radiotherapy encompassing heart.
  • Infusion reaction usually occurs within first 5 minutes of infusion and subsides with infusion interruption. Does not usually recur if infusion restarted at slower rate. Appears to be related to lipid component.

Patient Counseling Information

Package Inserts

Daunorubicin

Additional Information

Updated January 2018