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
新型抗癌药Vyxeos(Daunorubicin and Cytarabine for Injection)—是40多年来首个针对两种类型急性髓系白血病患者群体的全新化疗突破
2017年8月8日,FDA批准Daunorubicin/Cytarabine（商品名 Vyxeos，CelatorPharma公司）用于治疗两种类型的急性髓系白血病（AML）成人患者，即：1、新诊断为治疗相关性AML患者；2、骨髓增生异常相关改变的AML患者。
值得注意的是，Vyxeos是40多年来，针对这些患者群体的首个全新治疗突破。
AML是一种进展迅速的血液癌症，形成于骨髓，会导致血流中的白血细胞大量增加。据美国国家癌症研究所（NCI）统计，今年美国约有21,380人将被诊断为AML，10,590人会死于该病。其中，治疗相关性AML发生于8%-10%接受放化疗治疗癌症的患者，通常在治疗后五年内出现。而骨髓增生异常相关改变AML的特征就是患者有特定血液疾病病史以及其他癌细胞的重要突变。这两类患者的预后很差，预期寿命较短。
Vyxeos是一种由两种化疗药柔红霉素和阿糖胞苷组成的脂质体注射剂。“这是首个针对这两种高危AML的获批疗法，”FDA药物评价与研究中心血液和肿瘤产品办公室执行主任Richard Pazdur博士说，“Vyxeos将两种常用的化疗药按固定比例融合成一款药剂，相比单独接受两种药物治疗，使用Vyxeos治疗的患者生存期更长。”
Vyxeos的疗效和副作用
Vyxeos的安全性和有效性在一项试验中进行了验证。该试验纳入了309名新诊断为上述两种类型AML的患者，这些患者被随机分为2组，一组接受Vyxeos治疗，一组接受柔红霉素和阿糖胞苷单独治疗。研究发现，Vyxeos组中位总生存期为9.56个月，而单独接受柔红霉素和阿糖胞苷治疗的患者总生存期只有5.95个月。Vyxeos使患者的生存期显著延长。
Vyxeos的常见副作用包括出血、发热性中性粒细胞减少、皮疹、组织肿胀、恶性、黏膜炎、腹泻、便秘、肌骨痛、疲劳、腹痛、呼吸急促、头痛、咳嗽、食欲减退、心率异常、肺炎、菌血症、畏寒、睡眠紊乱及呕吐。
使用Vyxeos的注意事项
如果患者对柔红霉素和阿糖胞苷成分有严重过敏史，则不能使用Vyxeos。接受Vyxeos治疗的患者，应继续监测以防出现过敏反应或心脏功能降低。Vyxeos可能会导致严重甚至致命性的出血。还需注意如果在静脉输注中柔红霉素成分渗入皮肤或皮下组织，会导致严重的坏死。由于药物对胎儿及新生儿存在危害，因此妊娠期或哺乳期妇女不可使用Vyxeos。 |
