柔红霉素/阿糖胞苷,柔红霉素/阿糖胞苷复方冻干粉注射剂(Vyxeos 44mg/100mg)

药店国别:

产地国家:美国

处方药:

所属类别: 440毫克/100毫克/瓶 2瓶/盒

包装规格: 440毫克/100毫克/瓶 2瓶/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Jazz Pharmaceuticals

原产地英文商品名:Vyxeos Injection 44mg/100mg/Vial 2Vial/box

原产地英文药品名:daunorubicin and cytarabine

中文参考商品译名:Vyxeos复方冻干粉注射剂 440毫克/100毫克/瓶 2瓶/盒

中文参考药品译名:柔红霉素和阿糖胞苷

曾用名:

简介

新型抗癌药Vyxeos(CPX-351)—是40多年来首个获批用于2种特定白血病近日,美国FDA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。

批准日期:2017年8月8日

公司:爵士制药VYXEOS™(柔红霉素和阿糖胞苷脂质体 daunorubicin and cytarabine)注射,静脉内使用

初始美国批准:2017年

警告:不要与其它柔红霉素和/或阿糖胞苷的含汞产品互换见完整的黑框警告完整处方信息。•VYXEOS具有比盐酸柔红霉素注射,注射阿糖胞苷,柔红霉素柠檬酸盐脂质体注射液,和阿糖胞苷脂质体注射液不同剂量的建议。验证药物名称和剂量。

作用机制

用于注射的VYXEOS(柔红霉素和阿糖胞苷)脂质体是柔红霉素和阿糖胞苷的脂质体制剂,其固定的摩尔比为1:5。已显示柔红霉素:阿糖胞苷的1:5摩尔比在体外和鼠模型中杀死白血病细胞具有协同作用。

柔红霉素具有抗有丝分裂和细胞毒活性,其特征在于DNA形成,抑制拓扑异构酶II活性,抑制DNA聚合酶活性,影响基因表达的调节和DNA损伤自由基。阿糖胞苷是细胞周期阶段特异性抗肿瘤剂,仅在细胞分裂的S期期间影响细胞。阿糖胞苷通过抑制DNA聚合酶起作用。基于动物数据,脂质体进入并持续存在于骨髓中,在那里它们被骨髓细胞完整地取出。

在携带白血病的小鼠中,脂质体被白血病细胞摄取的程度大于正常骨髓细胞。细胞内化后,脂质体经历降解,在细胞内环境中释放出阿糖胞苷和柔红霉素。

适应症和用法

VYXEOS是柔红霉素对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,也被指示用于治疗与新诊断的治疗相关的急性髓细胞性白血病(T-AML)或AML成人脊髓发育不良有关的变化(AML-MRC)。

剂量和用量

•诱导:通过脂质体在第1天,3静脉内输注在90分钟内,和5以及第1天和第3 VYXEOS(2柔红霉素44mg /平方米和100阿糖胞苷毫克/平方米),用于如果需要感应的连续循环。

(2)•整合:VYXEOS(柔红霉素29毫克/米2和65阿糖胞苷毫克/米2),通过静脉内输注第1天和第3的脂质体在90分钟内剂量形式和强度对于注射:44毫克柔红霉素和阿糖胞苷100毫克脂质体封装为在单剂量小瓶用于重构的冻干饼。

禁忌症

•严重过敏柔红霉素,阿糖胞苷或制剂中任何成分的历史。

警告和注意事项

与相关的延长血小板减少•严重或致命的出血事件发生与VYXEOS。定期监测血液计数直至恢复。

•心脏:在患者的心脏功能不建议VYXEOS治疗确实偏少。患者中止VYXEOS除非有继续治疗的大于风险利益受损的心脏功能。

•如果发生严重或危及生命的过敏反应的,应停止VYXEOS,治疗gemäß的护理标准,并监测直至症状和体征解决。

•柔红霉素与当地组织坏死的药物外渗的网站被相关。小心管理VYXEOS。

•胚胎胎儿毒性:可导致胎儿伤害。建议的潜在风险胎儿的生殖潜力的女性,使用有效避孕。

不良反应

最常见的不良反应(发生率≥25%)为出血事件,发热性中性粒细胞减少,皮疹,水肿,恶心,黏膜炎,腹泻,便秘,肌肉骨骼疼痛,乏力,腹痛,呼吸困难,头痛,咳嗽,食欲减退,心律失常,肺炎,菌血症,寒战,睡眠障碍和呕吐。

药物相互作用

•与心脏毒性药物共同给药时,更频繁地监测心脏功能。

•与肝毒性药物共同给药时,更频繁地监测肝功能。

用于特定人群哺乳期:建议不要母乳喂养。

如何提供/存储和处理

如何提供用于注射的VYXEOS(柔红霉素和阿糖胞苷)脂质体是单剂量小瓶中的无菌,无防腐剂,紫色,冻干饼。 每个VYXEOS小瓶(NDC 68727-745-01)含有44mg柔红霉素和100mg阿糖胞苷。NDC 68727-745-02:装有2瓶VYXEOS的纸箱NDC 68727-745-05:装有5瓶VYXEOS的纸箱存储将未重构的VYXEOS样品瓶存放在冰箱中,温度为2°C至8°C(36°F至46°F),直立。 小瓶应存放在其原始纸箱中以防光。处理和处置VYXEOS是一种细胞毒性药物。 遵循适用的特殊处理和处理程序。

英文版说明

(cytarabine/ daunorubicin liposomal)IndicationVYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).Important Safety InformationWARNING:DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTSVYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.ContraindicationsVYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.Warnings and PrecautionsHemorrhageSerious or fatal hemorrhage events, including fatal CNS hemorrhages, associated with prolonged thrombocytopenia, have occurred with VYXEOS. The overall incidence (grade 1-5) of hemorrhagic events was 74% in the VYXEOS arm and 56% in the control arm. The most frequently reported hemorrhagic event was epistaxis (36% in VYXEOS arm and 18% in control arm). Grade 3 or greater events occurred in 12% of VYXEOS-treated patients and in 8% of patients in the control arm. Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and in 0.7% of patients in the control arm. Monitor blood counts regularly and administer platelet transfusion support as required.CardiotoxicityVYXEOS contains daunorubicin, which has a known risk of cardiotoxicity. This risk may be increased in patients with prior anthracycline therapy, preexisting cardiac disease, previous radiotherapy to the mediastinum, or concomitant use of cardiotoxic drugs. Assess cardiac function prior to VYXEOS treatment and repeat prior to consolidation and as clinically required. Discontinue VYXEOS in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk. VYXEOS is not recommended in patients with cardiac function that is less than normal.Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m2 have been associated with an increased incidence of drug-induced congestive heart failure. The tolerable limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS. VYXEOS is not recommended in patients whose lifetime anthracycline exposure has reached the maximum cumulative limit.Hypersensitivity ReactionsSerious or fatal hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine. Monitor patients for hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, interrupt or slow the rate of infusion with VYXEOS and manage symptoms. If a severe or life-threatening hypersensitivity reaction occurs, discontinue VYXEOS permanently, treat the symptoms, and monitor until symptoms resolve.Copper OverloadVYXEOS contains copper. Consult with a hepatologist and nephrologist with expertise in managing acute copper toxicity in patients with Wilson’s disease treated with VYXEOS. Monitor total serum copper, serum non-ceruloplasmin-bound copper, 24-hour urine copper levels, and serial neuropsychological examinations during VYXEOS treatment in patients with Wilson’s disease or other copper-related metabolic disorders. Use only if the benefits outweigh the risks. Discontinue in patients with signs or symptoms of acute copper toxicity.Tissue NecrosisDaunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation. Administer VYXEOS by the intravenous route only. Do not administer by intramuscular or subcutaneous route.Embryo-Fetal ToxicityVYXEOS can cause embryo-fetal harm when administered to a pregnant woman. Patients should avoid becoming pregnant while taking VYXEOS. If VYXEOS is used during pregnancy or if the patient becomes pregnant while taking VYXEOS, apprise the patient of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS.Most Common Adverse ReactionsThe most common adverse reactions (incidence ≥25%) were hemorrhagic events (74%), febrile neutropenia (70%), rash (56%), edema (55%), nausea (49%), mucositis (48%), diarrhea (48%), constipation (42%), musculoskeletal pain (43%), fatigue (39%), abdominal pain (36%), dyspnea (36%), headache (35%), cough (35%), decreased appetite (33%), arrhythmia (31%), pneumonia (31%), bacteremia (29%), chills (27%), sleep disorders (26%), and vomiting (25%).

 

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