英文药名：Vyxeos(Daunorubicin and Cytarabine for Injection)

中文药名：柔红霉素和阿糖胞苷复方注射剂

生产厂家：爵士制药
药品介绍
新型抗癌药Vyxeos(CPX-351)—是40多年来首个获批用于2种特定白血病
2017年8月8日，美国FDA正式批准药物Vyxeos用于2种成人初治急性髓性白血病：治疗相关性急性髓系白血病（t-AML）和伴骨髓增生异常相关改变的急性髓细胞白血病（AML-MRC）。Vyxeos是一种由化疗药物柔红霉素（daunorubicin）和阿糖孢苷（cytarabine）组成的固定剂量复方药物。这是首款针对特定类型急性髓性白血病（AML）的上市治疗药物，通过将两种常用化疗药组合使用，显着提高化疗效果，延长患者的生存时间。
作用机制
维克斯酮是柔红霉素，蒽环类拓扑异构酶抑制剂和阿糖胞苷（核苷代谢抑制剂）的脂质体组合。柔红霉素具有抗细胞毒性和细胞毒活性，其通过与DNA形成复合物，抑制拓扑异构酶II活性，抑制DNA聚合酶活性，影响基因表达调控和产生DNA损伤自由基来实现。阿糖胞苷是细胞周期相位特异性抗肿瘤药物，仅在细胞分裂的S期才影响细胞。阿糖胞苷主要通过抑制DNA聚合酶起作用。
推荐的剂量
Vyxeos专门用于治疗新诊断的治疗相关急性骨髓性白血病（t-AML）或具有骨髓增生异常相关变化的AML（AML-MRC）的成人。
Vyxos作为静脉内输注的脂质体提供。推荐的剂量方案如下：诱导：第1,3和5天以及第1和3天在90分钟内通过静脉内输注维甲酸（柔红霉素44mg/m 2和阿糖胞苷100mg/m 2）脂质体用于随后的诱导循环， 如果需要的话。巩固：在第1天和第3天通过静脉内输注90分钟，维肟（柔红霉素29mg /m 2和阿糖胞苷65mg /m 2）脂质体。
包装规格
单剂量瓶
440毫克/100毫克/瓶* 2瓶 5瓶
生产厂家：爵士制药
Vyxeos(Daunorubicin and Cytarabine for Injection)

VYXEOS
Generic Name and Formulations:
Daunorubicin, cytarabine 44mg/100mg (encapsulated in liposomes); per vial; lyophilized cake for IV infusion after reconstitution; contains copper; preservative-free.
Company:
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).
Adult:
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.
Children:
Not established.
Warnings/Precautions:
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).
Interactions:
Increased toxicity with concomitant cardiotoxic or hepatotoxic agents; monitor more frequently.
Pharmacological Class:
Anthracycline + antimetabolite.
Adverse Reactions:
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.
Generic Availability:
NO
How Supplied:
Single-dose vials—2, 5