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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于消化系统药物->止吐药物
处方药:处方药
包装规格: 235毫克/0.25毫克每小瓶 1小瓶/盒
计价单位:
  点击放大  
生产厂家英文名:
Helsinn Therapeutics (U.S.), Inc.
该药品相关信息网址1:
https://www.akynzeo.com/hcp/?gclid=EAIaIQobChMIjaHakdb24gIVCcRkCh1IbArkEAAYASAAEgLCYPD_BwE
该药品相关信息网址2:
https://www.rxlist.com/akynzeo-side-effects-drug-center.htm
原产地英文商品名:
AKYNZEO 235mg/0.25mg per vial 1vial/box (*Refrigerated)
原产地英文药品名:
Fosnetupitant and Palonosetron
中文参考商品译名:
AKYNZEO 235毫克/0.25毫克每小瓶 1小瓶/盒 (*药品需冷藏)
中文参考药品译名:
Fosnetupitant和帕洛诺司琼
原产地国家批准上市年份:
2018/04/20
英文适应病症1:
the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
临床试验期:
完成
中文适应病症参考翻译1:
用于预防与癌症化疗的初始和重复过程相关的急性和延迟性恶心和呕吐,包括但不限于高致吐性化疗。
药品信息:

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详细处方信息以本药内容附件PDF文件(201961915453924.pdf)的“原文Priscribing Information”为准
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部分中文AKYNZEO处方资料(仅供参考)

【英文名称】AKYNZEO

【适用证】

--- AKYNZEO胶囊与成人地塞米松合用,用于预防与癌症化疗的初始和重复过程相关的急性和延迟性恶心和呕吐,包括但不限于高致吐性化疗。

---注射用AKYNZEO与成人地塞米松联合用于预防急性和延迟性恶心和呕吐,与高致吐性癌症化疗的初始和重复过程相关。

使用限制

注射用AKYNZEO尚未研究用于预防与蒽环霉素加环磷酰胺化疗相关的恶心和呕吐。

AKYNZEO是帕洛诺司琼,一种5-羟色胺-3(5-HT)受体拮抗剂和netupitant或fosnetupitant,P物质/神经激肽-1(NK-1)受体拮抗剂的组合:帕洛诺司琼预防急性期恶心和呕吐和netupitant / fosnetupitant预防癌症化疗后急性期和延迟期的恶心和呕吐。 (1)

【用法用量】

在化疗开始前约1小时给予一个AKYNZEO胶囊,含或不含食物。(2.1)

一瓶注射用AKYNZEO; 在50ml 5%葡萄糖注射液,USP或0.9%氯化钠注射液,USP中重建,并在化疗开始前约30分钟开始给药30分钟。 (2.1,2.2,2.3)

【禁忌】

无 (4)

【注意事项】

---已经报道了接受帕洛诺司琼(AKYNZEO成分之一)的患者的过敏反应,包括过敏反应,有或没有已知的对其他5-HT受体拮抗剂的超敏反应。(5.1)

---据报道5-羟色胺综合征单独使用5-HT受体拮抗剂,特别是同时使用5-羟色胺能药物。 如果出现这种症状,停止AKYNZEO并开始支持治疗。 如果AKYNZEO与其他5-羟色胺能药物同时使用是临床保证,应该让患者意识到5-羟色胺综合征的潜在风险增加。(5.2,7.3)

【INDICATIONS AND USAGE】

---AKYNZEO capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

---AKYNZEO for injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

Limitations of Use

AKYNZEO for injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT ) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. (1)

【DOSAGE AND ADMINISTRATION】

One AKYNZEO capsule administered approximately 1 hour prior to the start of chemotherapy, with or without food.(2.1)

One vial of AKYNZEO for injection; reconstituted in 50 ml of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP and administered as 30-minute infusion starting approximately 30 minutes prior to the start of chemotherapy. (2.1, 2.2, 2.3)

【CONTRAINDICATIONS】

None (4)

【WARNINGS AND PRECAUTIONS】

---Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT receptor antagonists. (5.1)

---Serotonin syndrome has been reported with 5-HT receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue AKYNZEO and initiate supportive treatment. If concomitant use of AKYNZEO with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome. (5.2,7.3)

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详细处方信息以本药内容附件PDF文件(201961915453924.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-6-19
附件:
201961915453924.pdf    

 
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