How it is administered
Daunorubicin, when used for Acute Myeloid Leukemia (AML) in combination with cytarabine, is administered as part of a liposomal formulation for intravenous (IV) infusion. The medication is supplied as a sterile, preservative-free, purple, lyophilized cake in a single-dose vial. Each vial contains a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio, encapsulated in liposomes. The infusion is given over 90 minutes via a central venous catheter or a peripherally inserted central catheter. The dosing schedule varies depending on whether it is used for induction or consolidation therapy.
How it works
Daunorubicin is an anthracycline topoisomerase inhibitor. It works by forming complexes with DNA, which inhibits the activity of topoisomerase II and DNA polymerase. This action disrupts the regulation of gene expression and produces DNA-damaging free radicals, leading to cell death. When combined with cytarabine in a liposomal formulation, the two drugs are delivered together at a specific ratio that has been shown to have synergistic effects against leukemia cells.
The liposomes help the drugs persist in the bone marrow, where they are taken up by leukemia cells more than normal cells. Once inside the cells, the liposomes break down and release daunorubicin and cytarabine, allowing them to act directly within the leukemia cells to inhibit their growth and cause cell death.
Common side effects
- Hemorrhagic events (bleeding)
- Febrile neutropenia (fever with low white blood cell count)
- 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 (bacterial infection in the blood)
- Chills
- Sleep disorders
- Vomiting
All patients will experience low blood counts (neutropenia, thrombocytopenia, anemia) during treatment.
Who Should take it
Daunorubicin, in combination with cytarabine as a liposomal formulation, is indicated for adults and pediatric patients (1 year and older) with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
This treatment is specifically for patients who have these subtypes of AML, as it has been shown to improve overall survival compared to standard chemotherapy. The decision to use this medication should be made by a healthcare provider experienced in treating blood cancers.
Who should not take it
Daunorubicin should not be used in patients with a history of serious hypersensitivity reactions to daunorubicin, cytarabine, or any component of the formulation. It is also not recommended for patients with impaired cardiac function unless the benefits outweigh the risks, as daunorubicin can cause heart damage.
Patients who have reached the maximum lifetime cumulative dose of anthracyclines or who have certain copper-related metabolic disorders (such as Wilson’s disease) should avoid this medication unless closely monitored. It should not be used during pregnancy due to the risk of harm to the fetus.
Commonly used with
Daunorubicin is most commonly used in combination with cytarabine, especially in the treatment of AML. In the liposomal formulation, both drugs are delivered together at a fixed ratio for optimal efficacy.
It may also be used with supportive medications such as anti-emetics (to prevent nausea) and antibiotics (to prevent or treat infections) during treatment.
Commonly tested with
Daunorubicin has been tested in combination with cytarabine in clinical trials for AML, particularly in the liposomal formulation. It may also be studied with other agents that are used in the management of AML or other blood cancers, but the primary combination is with cytarabine.