How it is administered

Daunorubicin, when used in the combination liposomal formulation with cytarabine, is administered as an intravenous (IV) infusion. The medication comes as a sterile, preservative-free, purple, lyophilized cake in a single-dose vial. It is reconstituted and diluted before being given via a central venous catheter or a peripherally inserted central catheter. The infusion is typically given over 90 minutes.

The dosing schedule depends on the treatment phase:

• Induction: Daunorubicin 44 mg/m² (with cytarabine 100 mg/m²) on days 1, 3, and 5 for the first cycle, and on days 1 and 3 for a second cycle if needed.
• Consolidation: Daunorubicin 29 mg/m² (with cytarabine 65 mg/m²) on days 1 and 3.

This medication is not interchangeable with non-liposomal daunorubicin or cytarabine products.

How it works

Daunorubicin is an anthracycline topoisomerase inhibitor. In the liposomal formulation, it is combined with cytarabine at a fixed 1:5 molar ratio, which has been shown to have synergistic effects against leukemia cells.

Daunorubicin works by forming complexes with DNA, inhibiting the enzyme topoisomerase II, and interfering with DNA polymerase activity. This leads to the inhibition of DNA synthesis and repair, disruption of gene expression, and production of DNA-damaging free radicals. These actions result in the death of rapidly dividing leukemia cells.

When encapsulated in liposomes, daunorubicin and cytarabine are delivered more efficiently to the bone marrow, where leukemia cells are located. The liposomes are taken up by leukemia cells, and once inside, they release the drugs, maximizing their cancer-killing effects while potentially reducing exposure to healthy tissues.

Who Should take it

Daunorubicin (in combination with cytarabine as a liposomal injection) 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 pediatric patients 1 year and older.

It is not specifically indicated for Acute Lymphoblastic Leukemia (ALL), but is used in certain blood cancers, particularly specific subtypes of AML. Patients who have been diagnosed with these forms of AML and are eligible for intensive chemotherapy may be prescribed this medication as part of their treatment regimen.

Who should not take it

Daunorubicin (in the liposomal combination) should not be used in patients with:

• A history of serious hypersensitivity reactions to daunorubicin, cytarabine, or any component of the formulation.
• Cardiac function that is less than normal, as daunorubicin carries a risk of cardiotoxicity.

It is also not recommended for patients whose lifetime cumulative anthracycline exposure has reached the maximum limit, or those with certain copper-related metabolic disorders (such as Wilson’s disease) unless the benefits outweigh the risks. Pregnant women should not take this medication due to the risk of harm to the fetus.

Commonly used with

Daunorubicin (in the liposomal formulation) is always used in combination with cytarabine. This combination is specifically formulated and should not be substituted with other forms of daunorubicin or cytarabine.

It may also be used alongside supportive care medications such as anti-emetics, antibiotics, antifungals, and blood transfusions as needed.

Commonly tested with

Daunorubicin (liposomal) is tested in combination with cytarabine for the treatment of certain types of AML. In clinical studies, it is compared to the standard combination of cytarabine and daunorubicin (known as the 7+3 regimen) for efficacy and safety.

It is not typically tested with other chemotherapy agents outside of this specific combination for the approved indications.