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Black Box Warning
WARNINGS
See full prescribing information for complete Boxed Warning.
* Cardiac function should be monitored regularly in patients receiving DaunoXome (daunorubicin citrate liposome injection) because of the potential risk for cardiac toxicity and congestive heart failure. 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.
Severe myelosuppression may occur.
DaunoXome should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
Dosage should be reduced in patients with impaired hepatic function.
A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with DaunoXome in the Phase III clinical trial, 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.
Overview
Daunorubicin liposome is an anthracycline that is FDA approved for the treatment of advanced HIV-associated Kaposi's sarcoma. There is a Black Box Warning for this drug as shown here. Common adverse reactions include *Cardiotoxicity
Myelosuppression.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Daunorubicin liposome in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Daunorubicin liposome in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Daunorubicin liposome in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Daunorubicin liposome in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Daunorubicin liposome in pediatric patients.
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Daunorubicin liposome in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Daunorubicin liposome in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
Drug
Description
Use in Specific Populations
Pregnancy
Pregnancy Category
Labor and Delivery
There is no FDA guidance on use of Daunorubicin liposome during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Daunorubicin liposome with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Daunorubicin liposome with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Daunorubicin liposome with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Daunorubicin liposome with respect to specific gender populations.
Race
There is no FDA guidance on the use of Daunorubicin liposome with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Daunorubicin liposome in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Daunorubicin liposome in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Daunorubicin liposome in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Daunorubicin liposome in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Daunorubicin liposome in the drug label.
Description
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Daunorubicin liposome in the drug label.
