Generic Name and Formulations:
Daunorubicin, cytarabine 44mg/100mg (encapsulated in liposomes); per vial; lyophilized cake for IV infusion after reconstitution; contains copper; preservative-free.
Jazz Pharmaceuticals plc
Indications for VYXEOS:
Treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Calculate the prior cumulative anthracycline exposure before initiating each cycle. Give prophylactic antiemetics. Administer by IV infusion over 90mins. First induction: daunorubicin 44mg/m2 and cytarabine 100mg/m2 on Days 1, 3, and 5. Second induction (may give after 2–5 weeks if remission not achieved and no unacceptable toxicity): daunorubicin 44mg/m2 and cytarabine 100mg/m2 on Days 1 and 3. Consolidation (give 5–8 weeks after last induction): daunorubicin 29mg/m2 and cytarabine 65mg/m2 on Days 1 and 3. May give second consolidation 5–8 weeks after if no disease progression or unacceptable toxicity. Do not initiate consolidation until ANC recovers to >0.5Gi/L and platelet count >50Gi/L in the absence of unacceptable toxicity.
Do not interchange with other daunorubicin and/or cytarabine-containing products. Prior anthracycline therapy, pre-existing cardiac disease, or radiotherapy to mediastinum: increased risk of cardiotoxicity. Assess CBCs, cardiac, liver, and renal function prior to initiation. Discontinue if impaired cardiac function unless benefit outweighs risk. If LVEF below normal or max lifetime cumulative anthracycline exposure limit reached: not recommended. Monitor for hypersensitivity reactions; interrupt and reduce infusion rate if mild or moderate symptoms; permanently discontinue if severe/life-threatening reactions occur. Wilson's disease: use only if benefit outweighs risk. Monitor copper levels and serial neuropsychological exam; discontinue if signs/symptoms of acute copper toxicity develops. Avoid extravasation. Hepatic or severe renal impairment or ESRD: not studied. Embryo-fetal toxicity. Females of reproductive potential and males (with female partners) should use effective contraception during and for ≥6 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥2 weeks after last dose).
Increased toxicity with concomitant cardiotoxic or hepatotoxic agents; monitor more frequently.
Anthracycline + antimetabolite.
Hemorrhagic events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, vomiting; cardiotoxicity, copper overload, tissue necrosis.
Single-dose vials—2, 5