Vyxeos

Acute myeloid leukemia (AML) — newly diagnosed, therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults

Induction: Daunorubicin 44 mg/m² + cytarabine 100 mg/m² IV over 90 min on Days 1, 3, 5; may give second induction if needed
Consolidation (if CR/CRi): Daunorubicin 29 mg/m² + cytarabine 65 mg/m² IV over 90 min on Days 1, 3
Do NOT interchange with other daunorubicin or cytarabine products
Do NOT use in-line filter

For injection: Liposomal encapsulation of daunorubicin 44 mg and cytarabine 100 mg in a fixed 1:5 molar ratio per vial

History of serious hypersensitivity to any component.

• Hemorrhagic Events: Fatal and serious, including CNS hemorrhage. Occurred during induction and in setting of prolonged thrombocytopenia.
• Cardiotoxicity: Monitor cardiac function prior to and periodically during treatment. Total lifetime anthracycline exposure should be considered.
• Myelosuppression: Prolonged myelosuppression. Median time to neutrophil (ANC ≥500) recovery: 35 days; platelet (≥50K) recovery: 36 days.
• Hypersensitivity Reactions: Including serious. Monitor during infusion.
• Copper Overload: Contains copper gluconate; total copper exposure from 2 induction + 1 consolidation = 106 mg. Caution in Wilson disease or other copper disorders.

Hemorrhage (69%), febrile neutropenia (68%), rash (44%), edema (35%), nausea (33%), mucositis (32%), diarrhea (32%), constipation (28%), musculoskeletal pain (26%), fatigue (26%), abdominal pain (23%), dyspnea (23%), headache (21%), cough (19%), decreased appetite (21%), arrhythmia (18%), pneumonia (17%), bacteremia (17%)

Hemorrhagic events in 69% (Grade 3-5 in 12%, including fatal). Cardiotoxicity (monitor LVEF; do not use if LVEF below normal). Myelosuppression: prolonged count recovery (median 35-40 days). Hypersensitivity: serious reactions including anaphylaxis.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Hemorrhagic events in 69% (Grade 3-5 in 12%, including fatal). Cardiotoxicity (monitor LVEF; do not use if LVEF below normal). Myelosuppression: prolonged count recovery (median 35-40 days). Hypersensitivity: serious reactions including anaphylaxis.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Vyxeos is a liposomal formulation that encapsulates daunorubicin and cytarabine in a fixed 1:5 molar ratio within bilamellar liposomes. This ratio was selected to maximize synergistic anti-leukemic activity in vitro and in vivo. The liposomal formulation maintains this synergistic drug ratio in plasma and bone marrow for over 24 hours after administration, improving drug delivery to leukemia cells. Daunorubicin intercalates DNA and inhibits topoisomerase II; cytarabine inhibits DNA polymerase through incorporation of its triphosphate form into DNA.

Daunorubicin half-life: 31.5 hours; Cytarabine half-life: 40.4 hours. Liposomal encapsulation maintains 5:1 molar ratio (cytarabine:daunorubicin) in plasma and bone marrow. Vd: 4.8 L (daunorubicin), 6.6 L (cytarabine). Limited renal excretion.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• Study 301 — CPX-351 vs. 7+3 in newly diagnosed therapy-related AML or AML with MDS-related changes (age 60-75). Phase III, n=309.
  🔬 NCT01696084 ↗ 📄 Primary Publication ↗

Vyxeos has FDA-approved indications across the following cancer types covered on PipelineEvidence: