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  药店国别: 澳大利亚药房
产地国家: 澳大利亚
所属类别: 抗癌药物->治疗肠癌药物
处方药:处方药
包装规格: 5毫克/毫升 10毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
赛诺菲安万特
生产厂家英文名:
SANOFI
该药品相关信息网址1:
http://www.drugs.com/eloxatin.html
该药品相关信息网址2:
http://www.rxlist.com/eloxatin-drug.htm
该药品相关信息网址3:
http://products.sanofi-aventis.us/eloxatin/eloxatin.html
原产地英文商品名:
ELOXATIN concentrate for solution for infusion 5mg/ml 10ml
原产地英文药品名:
OXALIPLATIN
中文参考商品译名:
乐沙定 (集中用于输液) 5毫克/10毫升/瓶
中文参考药品译名:
奥沙利铂
原产地国家批准上市年份:
2005/01/31
英文适应病症1:
Colorectal Cancer
临床试验期:
完成
中文适应病症参考翻译1:
结直肠癌
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(201082519263830.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文乐沙定处方资料(仅供参考)

【药品名称】
商品名:乐沙定
通用名: 注射用奥沙利铂

【药理作用】
奥沙利铂为细胞抑制剂(L :抗癌药物-免疫抑制剂-铂类),ATC编号L01XA 03。奥沙利铂属于新的铂类抗癌药,其中铂原子与1,2二氨环己烷(DACH)及一个草酸基结合。奥沙利铂是单一对映结构体,顺式-[草(反式-1-1-1,2-DACH)铂]。奥沙利铂在多种肿瘤模型系统,包括在结直肠癌模型中,都表现出广谱的体外细胞毒性及体内抗肿瘤活性。体内、体外实验也证实在顺铂耐药的肿瘤模型中,它仍然有效。在体内和体外研究中,均可看到奥沙利铂与5-氟脲嘧啶联合应用有增效作用。关于奥沙利铂的作用机制,虽然尚未完全清楚,但已有研究表明,奥沙利铂通过产生水化衍生物作用于DNA,形成链内和链间交联,从而抑制DNA的合成,产生细胞毒作用和抗肿瘤活性。有关初治的转移性结直肠癌病人的研究经验表明,奥沙利铂(85 mg/m2,每2周重复)与5-氟脲嘧啶/甲酰四氢叶酸联合应用,同单独用5-氟脲嘧啶/甲酰四氢叶酸相比,其有效率提高1倍以上(49%对22%),无进展生存期也有所延长(8.2个月对6个月)。对生活质量的改善方面,二者的差别无统计学意义。但是,就总的健康状况和疼痛情况而言,对照组的生活质量评分要优于奥沙利铂治疗组,治疗组的恶心、呕吐状况较对照组更严重。在初治的转移性大肠癌病人中,给予奥沙利铂130 mg/m2,每3周1次,联合应用5-氟脲嘧啶/甲酰四氢叶酸,与单独使用5-氟脲嘧啶/甲酰四氢叶酸同样作了比较和评估。其有效率与“每2周1次,每次85 mg/m2”方案相同。奥沙利铂联合5-氟脲嘧啶/甲酰四氢叶酸的有效率要高1倍多(34%对12%),并可以延长无进展生存期(8.3个月对4.2个月)。但是,方案的安全性不同,两个方案比较列表如下 :造血系统 :消化系统:在3周方案中,消化道副反应的发生率更高。腹泻的发生率将随着治疗周期的重复而降低。中等程度的发热和感染(1度和2度)在3周方案中的发生率较低(分别为2%和6%)。神经系统毒性的发生率相似,当累积剂量接近800 mg/m2(6个周期),其发生率为15%或以下。在3周方案中,其剂量调整的原则与2周方案相同(将剂量从130 mg/m2减至100 mg/m2)。奥沙利铂作为二线治疗的有效率尚未进行评估。在一项II期临床研究中,对于接受5-Fu治疗后,确认病情进展的病人,在相同的5FU方案中加用奥沙利铂可以获得20%的有效率,且至少有30%的病人维持6个月病情无进展。

【药代动力学】
复合物中每个单个活性成份的药代动力学尚未确定。给予奥沙利铂130 mg/m2,静脉输注2小时,每3周1次,共5个周期时,其超滤铂(未结合的有活性和无活性的铂类片段的混合物)药代动力学如下 :
在2小时输液结束时,15%的铂存在于周围循环中,剩余的85%迅速扩散到组织内或者随尿排出。
由于奥沙利铂可与红细胞和血浆蛋白进行不可逆的结合,导致结合物的半衰期接近红细胞和血浆白蛋白的自然寿命。85 mg/m2每2周1次,或130 mg/m2每3周1次,未见到血浆超滤液中有蓄积现象,第1周期中可以保持稳定状态。个体间及个体内差异通常较低。在体外,生物转化被认为是非酶性降解的结果。尚无证据表明细胞色素P450介导了DACH环的分解代谢。奥沙利铂在病人体内要进行充分的生物转化。2小时输注结束后,血浆超滤物中检测不到完整的药物。几种细胞毒性生物转化产物包括一氧化物、二氧化物和diaquo化-DACH铂类成分等,均可在周围循环系统中检测出来,稍后,还可发现许多非活性的结合物。
铂类主要经尿排出,多在用药后48小时内清除。第5天时,大约有54%随尿排出,只有不到3%随粪便排出。当肾功能不全,清除率明显下降,如从17.6 ± 2.18 L/h降到9.95 ± 1.91 L/h时,其分布体积也显著下降,从330 ± 40.9 L降到241± 36.1 L,统计学上有显著差异。严重肾功能不全时,对铂类清除率的影响尚未进行评估。

【毒理研究】
作为单药和多种剂量在临床前对多种动物(包括小鼠、大鼠、狗和/或猴),进行靶器官的研究,它们包括 :骨髓、消化系统、肾脏、睾丸、神经系统,以及心脏等。在动物中观察到的靶器官毒性除了心脏以外,其它的毒性反应与其它含铂类药物、DNA损伤和细胞毒药物产生的毒性一致。心脏毒性仅在狗中见到,包括电生理异常导致的致死性室颤。心脏毒性对狗有特异性,不仅因为它仅仅发生在狗身上,而且因为引起狗致死性心脏毒性的相似剂量(150 mg/m2)在人可以很好地耐受。
奥沙利铂在哺乳动物中可以导致基因突变,在大鼠中可以产生胎儿致死性的毒副作用。也有人认为奥沙利铂有可能是一种致癌物,尽管尚无此方面的研究。

【适应症】
与5-Fu和甲酰四氢叶酸联合一线应用治疗转移性结直肠癌。

【用法用量】
限成人使用。作为一线治疗,奥沙利铂推荐剂量为85 mg/m2静脉输注,每2周重复1次。应按照病人的耐受程度进行剂量调整。
奥沙利铂应在输注氟脲嘧啶前给药。
将奥沙利铂溶于5%葡萄糖溶液250-500 mL中,持续输注2-6小时。
奥沙利铂主要用于以5-氟脲嘧啶持续输注为基础的联合方案中。在双周方案中,5-氟脲嘧啶采用推注与持续输注联合的给药方式。
特殊人群 :
- 肾功能不全者 :本药尚无用于严重肾功能不全患者的资料。中度肾功不全者,开始治疗时可给予常规推荐剂量。对于轻度肾功能不全者,无需调整剂量。
- 肝功能不全者 :对于有严重肝功能不全者,本药应用尚无研究。对于治疗开始时肝功能检查不正常的患者人群,应用本药未出现急性毒性的增加。在临床研究中,肝功能不全者未进行特别的剂量调整。
给药方法 :奥沙利铂用于静脉输注,使用时无需水化。将奥沙利铂溶于5%葡萄糖溶液250-500 mL中,通过外周或中央静脉滴注2-6小时。奥沙利铂必须在5-氟脲嘧啶前滴注。如果漏于血管外,必须立即终止给药。

【不良反应 】
在244例单用奥沙利铂病人、1500例用奥沙利铂与5-Fu联合治疗的转移性大肠癌病人中对其不良反应进行了评估。
造血系统 :奥沙利铂单药(130 mg/m2,每3周重复),很少引起3-4级造血系统毒性。
当奥沙利铂与5-Fu和甲酰四氢叶酸联合使用时,中性粒细胞减少和血小板减少的发生率要高于单用5Fu/甲酰四氢叶酸治疗。
消化系统 :单独应用奥沙利铂(130 mg/m2,每3周)可引起恶心,呕吐和腹泻,通常不太严重。
建议给予预防和/或治疗性的止吐用药。当奥沙利铂与5-Fu(有或没有甲酰四氢叶酸)联合使用时,腹泻和粘膜炎的发生率和程度较单独用5-Fu时显著增加。
在奥沙利铂治疗期间常会出现转氨酶升高(1-2级)。在一项随机研究中显示,5-Fu/甲酰四氢叶酸和5-Fu/甲酰四氢叶酸+奥沙利铂两组3-4级转氨酶升高的发生率相似。
神经系统 :奥沙利铂的剂量限制性毒性是神经系统毒性,主要表现在外周感觉神经,表现为末端感觉障碍或/和感觉异常。伴或不伴痛性痉挛,通常遇冷会激发。这些症状在接受治疗的病人中的发生率为85-95%。在治疗间歇期,症状通常会减轻,但随着治疗周期的增加,症状也会逐渐加重。根据症状持续的时间,疼痛和/或功能障碍的发生是进行剂量调整的指征,甚至有时需要中止治疗。功能障碍包括不能完成精细动作,与感觉障碍相关。当累积剂量接近800 mg/m2(即10个周期)时,出现功能障碍的危险性为15%或以下。当治疗停止后,神经系统症状通常可以改善。
在奥沙利铂治疗期间有急性咽喉痉挛的报导。根据临床研究和药物监测数据估计,它的发生率在1%和2%之间。通常是在给药后几小时内出现,并且常常是发生在遇冷时。表现为主观上感觉吞咽困难和呼吸困难,但没有任何呼吸道梗阻的客观依据(缺氧、喉痉挛、支气管痉挛)。颌痉挛,异常的舌部感觉以及随后可能出现的语言障碍和胸闷等,也曾报道。虽然发生这些症状时,可以给予抗组胺药和支气管扩张剂,但即使不做任何处理,这些症状也可以迅速逆转。在以后的治疗中延长注射的时间,可以减少这些症状的发生率。
其它的一些神经系统症状,如深部反射的消失和Lhermittes''''''''''''''''s征也有报道。
变态反应 :一些罕见的变态反应,包括皮肤红斑到过敏性休克等,已经在其它铂类衍生物中有描述。在临床应用中,奥沙利铂发生过敏反应的机率是0.5%。上市后应用的经验表明,这种反应的发生率同临床实验时比较,并未见增高。
其它反应 :奥沙利铂耳毒性的发生率不到1%,无严重听力损伤的报导。
肾功能异常的比例,据报道约为3%,但发生3-4级的比例不到1%。
在临床和上市后研究中,没有关于奥沙利铂引起心律失常的报道。
与5-Fu联合应用,36%的病人会有中度发热,此外,23%的病人会出现1-2度的感染。发热性中性粒细胞减少发生率小于2%。
奥沙利铂单药治疗时,中度脱发的发生率为2%。和5-Fu联合使用时,脱发发生率的比例并不比5-Fu单药时高。
奥沙利铂有轻微的致糜作用,轻度到中度的局部炎症有报道。
不到0.1%的病人在用药期间会出现一过性视力下降。

【禁忌症】
奥沙利铂禁用于以下病人 :已知对奥沙利铂过敏者 ; 哺乳期妇女 ; 在第1疗程开始前已有骨髓抑制者,如中性粒细胞计数 < 2 x 109/L和/或血小板计数 < 100 x 109/L; 在第1疗程开始前有周围感觉神经病变伴功能障碍者 ;有严重肾功能不全者(肌酐清除率小于30 mL/分)。

【警告】
本药必须在专门的肿瘤科使用,必须在有经验的肿瘤专科医生的指导下给药。

【注意事项】
奥沙利铂没有表现出肾脏毒性。然而,对中度肾功能不全病人应用尚缺乏足够的安全性研究的资料。因此,必须慎重权衡利弊选择适合的病人使用。在这种情况下,必须密切监测肾功能,并按照毒性程度调整剂量。
对于有铂类化合物过敏史的病人,应监测过敏症状。一旦发生任何过敏样反应,应立即停止给药,并给予积极的对症治疗,禁止再用奥沙利铂。
奥沙利铂致糜作用轻微。然而,一旦漏于血管外,应立即中止注射,并局部对症治疗。
对奥沙利铂的神经系统毒性应进行仔细监测,特别是与其它有神经系统毒性的药物合用时。每次治疗前都要进行神经系统检查,以后定期复查。
如果用2小时滴注给药时,病人出现急性喉痉挛,下次注射奥沙利铂时,应用6小时滴注给药。
如果出现神经系统症状(感觉障碍、痉挛),那么依据症状持续的时间和严重程度推荐以下方法调整奥沙利铂的剂量 : 如果症状持续7天以上而且较严重,或无功能不全的感觉障碍一直持续到下一周期,应将奥沙利铂的剂量从85 mg/m2 减至65 mg/m2。如果有功能不全的感觉障碍一直持续到下一周期,应停止应用奥沙利铂。如果在停止使用奥沙利铂后,这些症状有所改善,可考虑继续奥沙利铂治疗。
消化道毒性主要表现为恶心和呕吐,建议给予预防性和/或治疗性止吐用药。
如果出现血液学毒性(白细胞 < 1.5 x 109/L,或血小板计数 < 50 x 109/L),下一周期的治疗应推迟,直到血液学指标恢复到适当的水平。每次治疗前应进行全血细胞计数和白细胞分类。
如果奥沙利铂与5-Fu(用或不用四氢叶酸)合用,应根据5-Fu相关的毒性作相应的剂量调整。如果出现WHO 4级腹泻,3-4级中性粒细胞减少症(< 1.0 x 109/L),3-4级血小板减少(< 50 x 109/L),则奥沙利铂的剂量要减少25%。而且5-Fu的剂量也应减少。

【孕妇及哺乳期妇女用药】
目前尚无资料确定奥沙利铂在孕妇中使用的安全性。根据临床前的经验,推荐量的奥沙利铂可以致死和/或致畸。因此,在孕妇中,不主张用奥沙利铂。只有在对胎儿的危险性进行了充分的评价并征得了病人的同意后,方可考虑使用奥沙利铂。
通过乳汁排出的研究尚未进行,奥沙利铂禁用于哺乳期。

【老年患者用药】
对于年龄超过65岁的患者,本药作为单药或与5-Fu联合应用,都未见有严重毒性反应的出现。因此,对于老年患者,没有特殊的剂量调整。

【药物相互作用】
病人在接受奥沙利铂85 mg/m2后,立即给予5-Fu,5-Fu的水平没有什么变化。另外,体外研究证明,下列药物不影响奥沙利铂与血浆蛋白的结合 :红霉素、水杨酸盐、格拉司琼、紫杉醇和丙戊酸钠。

【药物过量】
尚无解毒剂可供使用。一旦出现用药过量时,不良反应会加剧,应开始血液学监测,并进行对症治疗。

【有效期】
成品有效期:3年。溶解液:原包装瓶中重新配制的溶液,其物理和化学的稳定性在2°C-8°C之间和30°C时可保持48小时。从微生物学角度看,溶解的溶液应立即稀释。如果不立刻稀释,那么使用者应注意,在使用前放置的时间在2°C到8°C之间不应长于24小时,除非溶解是在特定的条件下进行的。没有贮存的特殊警告。

Eloxatin
Generic Name: oxaliplatin (ox AL ih plat in)
Brand Names: Eloxatin

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What is Eloxatin?
Eloxatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body. It is an antineoplastic and works by killing cancer cells and slowing tumor growth.

Eloxatin is used together with other cancer medications to treat colon and rectal cancer.

Eloxatin may also be used for other purposes not listed in this guide.

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Important information about Eloxatin
Do not use Eloxatin without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not receive Eloxatin if you are allergic to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).

Before receiving Eloxatin, tell your doctor if you are allergic to any drugs, or if you have liver disease, asthma, or a nerve problem.

Receiving Eloxatin can make you more sensitive to cold. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort avoid breathing in cold air, cover your skin in cold weather, wear gloves when handling cold objects, avoid air conditioning, and do not use ice or drink cold beverages.

Do not eat ice chips to ease mouth sores or nausea because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores.

Call your doctor if you have a serious side effect such as numbness or tingling, problems with speech or swallowing, chest tightness, fever with diarrhea or vomiting, increased thirst, decreased urination, easy bruising or bleeding, weakness, or mouth sores.

Eloxatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed or get sick. Avoid being around others who are ill. Your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled appointments.

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Before receiving Eloxatin
You should not receive Eloxatin if you are allergic to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive Eloxatin:
liver disease;
asthma or other breathing disorder; or
a nerve problem.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive Eloxatin without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether Eloxatin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

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How is Eloxatin given?
Eloxatin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up at least 2 hours to complete.

Eloxatin is usually given as part of a 2-day treatment every 2 weeks. Follow your doctor's instructions.

Receiving Eloxatin can make you more sensitive to cold. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort, follow these steps:
do not inhale deeply when you are exposed to cold air;
cover your skin, head, and face when you are outside in cold temperatures;
wear gloves when handling cold objects or refrigerated foods;
do not run an air conditioner at very cool temperature in your home or car (even during hot weather);
do not drink cold drinks or use ice cubes in drinks;
do not put ice packs on your body.

Chemotherapy often causes nausea or mouth sores. Do not eat ice chips to ease these discomforts because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores. You may be given other medications to prevent nausea or vomiting while you are receiving Eloxatin.

Eloxatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled appointments.

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What happens if I miss a dose?
Contact your doctor if you miss an appointment for your Eloxatin injection.

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What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include easy bruising or bleeding, unusual weakness, severe vomiting or diarrhea, numbness or tingling, flu symptoms, wheezing, trouble breathing, chest pain, slow heart rate, weak or shallow breathing (breathing may stop).

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What should I avoid while using Eloxatin?
Eloxatin can make you more sensitive to cold. Avoid cold temperatures and cold objects, including ice, cold drinks, and skin exposure to cold temperatures.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Eloxatin can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.

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Eloxatin side effects
Some people receiving a Eloxatin injection have had a reaction to the infusion within minutes after the medicine is injected into the vein. Tell your caregiver right away if you feel short of breath, confused, sweaty, itchy, or have diarrhea, chest pain, warmth or redness in your face, or feel like you might pass out.

Get emergency medical help if you have any of these signs of an allergic reaction to Eloxatin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
numbness or tingly feeling in your hands, feet, throat, and around your mouth;
numbness or burning pain that interferes with daily activities;
increased sensitivity to cold temperatures and cold objects;
jaw or chest tightness, eye pain, strange feeling in your tongue, problems with speech or swallowing;
fever, diarrhea, vomiting, chills, body aches, flu symptoms, sudden cough;
increased thirst, dry mouth, urinating less than usual;
decreased vision;
easy bruising or bleeding, unusual weakness; or
white patches or sores inside your mouth or on your lips.

Less serious Eloxatin side effects may include:
nausea, stomach pain, loss of appetite;
constipation;
tired feeling;
hair loss;
decreased taste sensation;
muscle pain;
headache;
sleep problems (insomnia);
swelling; or
back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Eloxatin?
Before you receive Eloxatin, tell your doctor if you also take a blood thinner such as warfarin (Coumadin).

There may be other drugs that can interact with Eloxatin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Where can I get more information?
Your doctor or pharmacist can provide more information about Eloxatin.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or propriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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更新日期: 2015-09-15
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