How it is administered
Daunorubicin, when used in the combination liposomal formulation with cytarabine, is administered intravenously (IV) as an infusion. It is not given by mouth or as an injection into the muscle or under the skin. The medication comes as a sterile, preservative-free, purple, lyophilized cake in a single-dose vial, which is reconstituted and diluted before administration. The infusion is typically given over 90 minutes through a central venous catheter or a peripherally inserted central catheter.
How it works
Daunorubicin is an anthracycline topoisomerase inhibitor. In the liposomal combination with cytarabine, it is delivered at a fixed 1:5 molar ratio, which has been shown to have synergistic effects in killing leukemia cells. Daunorubicin works by forming complexes with DNA, inhibiting the activity of topoisomerase II, and interfering with DNA polymerase activity. This leads to disruption of DNA replication and repair, affecting the regulation of gene expression and producing DNA-damaging free radicals, ultimately resulting in cell death.
When encapsulated in liposomes, daunorubicin and cytarabine persist longer in the bone marrow and are taken up by leukemia cells more than by normal bone marrow cells. After the liposomes are internalized by the cells, they are degraded, releasing the active drugs inside the cell, where they exert their effects.
Common side effects
- Hemorrhagic events (bleeding)
- Febrile neutropenia (fever with low white blood cells)
- Rash
- Edema (swelling)
- Nausea
- Mucositis (mouth sores)
- Diarrhea
- Constipation
- Musculoskeletal pain
- Fatigue
- Abdominal pain
- Dyspnea (shortness of breath)
- Headache
- Cough
- Decreased appetite
- Arrhythmia (irregular heartbeat)
- Pneumonia
- Bacteremia (blood infection)
- Chills
- Sleep disorders
- Vomiting
All patients develop severe neutropenia, thrombocytopenia, and anemia during treatment.
Who Should take it
Daunorubicin, in combination with cytarabine as a liposomal formulation, is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and children 1 year and older.
This combination is specifically used for patients who have these subtypes of AML, as it has been shown to improve survival compared to standard chemotherapy. It is not indicated for other types of blood cancers or for cutaneous T-cell lymphoma.
Who should not take it
Patients who have a history of serious hypersensitivity reactions to daunorubicin, cytarabine, or any component of the formulation should not take this medication. It is also contraindicated in patients with severe cardiac dysfunction or those whose lifetime anthracycline exposure has reached the maximum cumulative limit, due to the risk of heart damage.
Pregnant women should avoid this medication, as it can cause harm to the unborn baby. Patients with Wilson’s disease or other copper-related metabolic disorders should only use it if the benefits outweigh the risks, due to the copper content in the formulation.
Commonly used with
Daunorubicin is commonly used in combination with cytarabine, especially in the liposomal formulation for certain types of AML. It may also be used alongside supportive medications such as anti-emetics to prevent nausea, antibiotics to prevent or treat infections, and transfusions to manage low blood counts.
Commonly tested with
Daunorubicin has been tested in combination with cytarabine as the standard of care for certain subtypes of AML. It is also compared to other chemotherapy regimens in clinical trials for leukemia. In some studies, it may be used with other agents that target leukemia cells or in combination with stem cell transplantation protocols.