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  药店国别: 德国药房
产地国家: 德国
所属类别: 维生素类及微量元素药物->铁过量
处方药:处方药
包装规格: 125毫克/片 84片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
诺华
生产厂家英文名:
Novartis Pharma GmbH
该药品相关信息网址1:
http://www.exjade.com/
该药品相关信息网址2:
http://www.drugs.com/exjade.html
该药品相关信息网址3:
http://www.rxlist.com/exjade-drug.htm
原产地英文商品名:
EXJADE TAB 125MG/TAB 84TABS/BTL
原产地英文药品名:
DEFERASIROX
中文参考商品译名:
恩瑞格片 125毫克/片 84片/瓶
中文参考药品译名:
地拉罗斯
原产地国家批准上市年份:
2005/11/02
英文适应病症1:
Iron overload
临床试验期:
完成
中文适应病症参考翻译1:
铁过量
药品信息:

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 详细处方信息以本药内容附件PDF文件(201221918144036.pdf)的“原文Priscribing Information”为准
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部分中文地拉罗斯处方资料(仅供参考)

Deferasirox治疗铁过量
2004年底在美国圣地亚哥召开的第46届美国血液学协会年会上提交的研究报告显示,Deferasirox(商品名Exjade,ICL670)(Ⅰ),一种口服每日一次的铁螯合剂,治疗儿童和成人铁过量均有效。该Ⅲ期研究纳入近600名地中海贫血患者,(Ⅰ)呈剂量依赖性减少肝脏铁浓度(LIC),与现有标准治疗药物去铁胺(deferoxamine)(Ⅱ)相比较在同一水平。

药品名称
中文药名: 地拉罗斯片
商品名: Exjade 恩瑞格

生产厂家
Novartis Pharmaceuticals Corp.诺华公司

药品介绍
2005年11月2日,诺华公司宣布,该公司铁螯合剂产品deferasirox(又名Exjade, ICL670,地拉罗斯)获得FDA批准上市。本品为首个1日一次的口服铁螯合剂产品,获准的适应证为2岁及以上儿童和成人患者由输血导致的慢性铁超负荷。
铁超负荷是一种渐进性的、可以危及生命的疾病,常常是频繁输血的不可避免的并发症。某些慢性血液疾病需要长期、频繁的输血,这些患者很可能发生铁超负荷,如海洋性贫血、镰刀细胞贫血、骨髓异常增生综合征等。铁超负荷的征象可能在10~20次输血后就可显现。如果不加治疗,体内过量的铁会损害肝脏、心脏和内分泌腺。铁螯合剂是目前唯一有效的治疗输血相关铁过负荷的方法。
本品被认为是铁螯合治疗领域的重大突破。现有的标准治疗药物需要每周5-7次、每次8-12h皮下输注,并且只要患者继续接受输血或存在铁超负荷情况这样的治疗就将持续。给药的不便使很多患者放弃了治疗。而本品的给药就象喝果汁一样方便,服用前只须将片剂溶在水里或果汁里。因此本品的出现极大地改善了铁螯合治疗的方便性,特别是对于儿童。
但近日美国FDA和诺华公司发出通告,更改铁鳌合剂地拉罗斯(Exjade)产品说明书的“警告”和“不良反应”部分。因该药上市后的监测显示,有些病人用该药后发生急性肾衰(有些是致死性的),大部分死亡病例有多种共存病,并处于血液病的晚期。
还有报告表明,用该药治疗的病人发生血细胞减少症,包括粒细胞缺乏症、中性粒细胞减少症和血小板减少症,一些病人死亡。这些事件与地拉罗斯治疗的关系尚不确定。
FDA告诫,对于并发症危险增加的病人(有肾功能障碍、年老、有共存病者,或正在用的药物有抑制肾功能者)应定期监测其血肌酐水平和血细胞计数。
口服排铁剂Deferasirox(地拉罗斯):
慢性贫血如重度海洋性贫血、镰刀型贫血及骨髓发育不良症候群等患者,通常需要终生输血以维持生命,然而长期输血可能导致铁质沉积症(ironoverload)。
慢性铁质沉积症会引起心脏、肝脏、内分泌腺等器官伤害,严重更可能危及生命,因此需要排铁剂治疗。
于2007年1月核准新的口服排铁剂地拉罗斯,用于治疗2岁以上因输血而导致慢性铁质沉着症。 地拉罗斯为铁质螯合剂,对于三价铁离子具高度亲和力,2个分子可与1个三价铁离子结合。
地拉罗斯口服吸收后可进入细胞内(特别是心肌细胞)与铁质螯合,经由肝脏代谢、经胆汁分泌至粪便中排出。
近来研究显示deferasirox(地拉罗斯)与deferoxamine用于慢性铁质沉着症之效果相当。 Deferasirox(地拉罗斯)起始剂量为每日每公斤20 mg,视临床治疗情况每3-6个月调整剂量。
Deferasirox(地拉罗斯)为可溶锭(dispersibletablet),以100-200 cc开水、柳橙汁或苹果汁溶解,搅拌均匀成为乳白色悬浮液服用,服药待30分钟后才可进食。
Deferasirox(地拉罗斯)副作用轻微且短暂,多为皮肤红疹及肠胃道副作用如恶心、呕吐、腹痛、腹泻及便秘等,少见副作用为肌酸酐(用于评估肾脏功能)上升、肝脏酵素上升、视力及听力障碍等。
Deferasirox(地拉罗斯)很少药物交互作用,惟用药期间应避免使用含铝盐的制酸剂,以免降低药效。
服药期间需定期监测血清内铁蛋白(ferritin)、肾功能、肝功能及白血球数目等。
Deferasirox(地拉罗斯)的怀孕用药分级为B级:动物试验显示对胎儿无害,但没有用于怀孕女性的报告;目前亦无用于授乳妇女的报告。
口服排铁剂因使用方便,比起传统皮下注射排铁剂有较高的接受度与满意度,且可提升患者的生活品质,对长期需使用排铁剂者实为一大福音。
Deferasirox(地拉罗斯)治疗慢性铁质沉积症属安全且有效,目前属于新药监视期,临床累积经验不及deferoxamine,用于人群的效果及安全性仍待长期评估。

药理
地拉罗斯是一种口服除铁剂,可替身体器官清除积聚的铁质,减少因长期铁质积聚所引致的并发症。

适应症
用于因需要长期输血而引致铁质积聚的患者(如患有地中海贫血症或其他罕见的贫血症) ,适用于两岁以上儿童及成人服用。

用法用量
建议有铁质积聚患者,例如需要长期输血人 (输血量达100毫升/公斤) 及血清铁蛋白超过1000微克/升;对应身体重量,初期建议每日服用20毫克 / 公斤剂量的地拉罗斯,视乎血清铁蛋白指标的改善情况,患者可能需要调校或增加服用地拉罗斯的剂量,一般会以5毫克 / 公斤或10毫克 / 公斤为单位作剂量调升,但服用总剂量不应超过每日30毫克 / 公斤。
病患者及家属注意事项: 1. 应在餐前30分钟服用。 2. 应在每日相同时间服用。
任何疑问,请遵医嘱!

不良反应
现存不良反应事件中,部分是致命的。
其中,骨髓增生异常综合征(MDS一种骨髓功能异常和自身难以产生足够血细胞的病症)患者较其他患者使用Exjade可能存在较高的不良反应风险,如肾衰竭、胃肠出血(潜在致命性出血)和死亡。年轻慢性贫血症患者如β珠蛋白生成障碍性贫血和镰状红细胞病患者,发生死亡和严重不良反应的发生率较低。大于60岁MDS患者年龄,不良反应并不普遍存在。因此目前FDA尚未明确MDS患者或老年患者使用Exjade治疗时发生不良反应的风险高的结论。FDA还将考虑该药治疗的相关因素:包括患者的年龄、所患疾病的严重程度、其它药物的干扰和对输血的需求。
FDA与Exjade的制造商诺华公司在为药品说明书处方信息的修订而共同商讨,目的以警示特定人群使用Exjade存在潜在风险。

用药注意:
1.erasirox 可能会引起皮疹,一般皮疹会自动消失而不需作剂量调校或停止用药;若情况严重或持续,便应停止用药。
2. 患者视觉或听觉可能会有影响。

常见副作用: 腹泻、呕吐、头痛、腹痛、发烧、皮疹、增加血清肌酸酐(Creatinine)等。

其他副作用: 肝酵素增加、咳嗽、喉咙发炎、麻疹。

禁忌
对地拉罗斯或当中任何成份过敏人士

药物相互作用
不宜与含有铝质的药物(如中和胃酸药)同服。
 
EXJADE is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years and older. In these patients, EXJADE has been shown to reduce liver iron concentration and serum ferritin levels. Clinical trials to demonstrate increased survival or to confirm clinical benefit have not been completed.
Talk to your doctor to determine if EXJADE therapy is right for you. The expected benefit and risks of the therapy, as well as factors such as life expectancy and other illnesses should be considered.
The safety and efficacy of EXJADE when taken with other iron chelation therapy have not been proven.
Further studies are being performed to determine the long-term benefits and risks of EXJADE.
EXJADE is available by prescription only.

Important Safety Information
What is the most important safety information to know about EXJADE?
EXJADE may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems and bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years. All of these were more common in patients with high-risk myelodysplastic syndromes, pre-existing kidney problems, or low, blood counts (low platelets).

Your doctor should check your kidneys with a blood test called serum creatinine and/or creatinine clearance:
Before taking EXJADE
Monthly during treatment

If you already have a history of kidney problems or are at risk for kidney problems your doctor should check your kidneys:
Every week for the first month
Monthly during treatment

Your doctor should check your liver with blood tests called serum transaminases and bilirubin:
Before taking EXJADE
Every other week for the first month after starting EXJADE
Monthly during treatment

Certain people should not take EXJADE, including:
People with certain kinds of kidney problems
People with high-risk myelodysplastic syndromes or cancers
People with low blood counts (low platelets)
People who are allergic to EXJADE or any ingredient of EXJADE

Kidneys: If you are at increased risk of complications because you have a pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your kidneys, your doctor will give you a blood test every week for the first month you are taking EXJADE or if your dose has changed, and then every month after that. Your doctor may also collect urine samples monthly.

Some patients developed severe kidney problems while on EXJADE, in some cases fatal, and in some cases requiring dialysis. Most of the fatalities occurred in patients who were very ill because of their disease. There may be increased risk of complications for patients who already have a kidney condition, are elderly, have multiple medical conditions, or take medicine that affects kidney function.

Liver: People with pre-existing severe liver problems should not use EXJADE. A lower starting dose of 10 mg/kg/day is recommended for people with moderate liver problems. Anyone using EXJADE who has mild or moderate liver problems should be closely monitored. They may need their dose adjusted based on efficacy or safety.

Some patients developed severe liver problems, in some cases fatal, while on EXJADE. Many of these patients were greater than 55 years of age and/or had multiple medical conditions already affecting their liver. Your doctor will give you blood tests called serum transaminases and bilirubin before starting treatment, every 2 weeks during the first month of treatment, and then monthly.

Stomach: Some patients developed stomach irritation or bleeds while on EXJADE. In some cases, stomach bleeds were fatal, usually in patients who were elderly and had pre-existing blood cancers and/or low blood counts (low platelets). Talk to your doctor if you are taking other drugs which can also irritate your stomach or cause a stomach bleed (e.g., NSAIDs, corticosteroids, oral bisphosphonates, blood thinners).

Blood Disorders: Some patients developed blood disorders, in some cases fatal, while on EXJADE therapy, but it is not known whether this was a result of EXJADE therapy or other causes, as most of these patients already had diseases affecting their blood.

Allergic Reactions: Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment. If reactions are severe, stop taking EXJADE and contact your doctor immediately.

Serious Reactions: Should you develop swelling of the throat, a severe rash, or any hearing problems or vision disturbances, please contact your doctor immediately.
Rash: A skin disorder that results in a very serious rash, called erythema multiforme, has been reported during treatment with EXJADE.

Comorbidities: Since EXJADE has been on the market, there have been reports of some serious reactions, sometimes leading to death. These serious reactions happened most often when EXJADE was taken by elderly patients, those with multiple medical conditions, or those with advanced diseases. Most of these deaths happened within 6 months of starting EXJADE, and the original disease usually got worse. The reports do not rule out the possibility that EXJADE may have contributed to the deaths.

How to Take EXJADE: EXJADE should be taken once daily on an empty stomach, at least 30 minutes prior to food, preferably at the same time every day.

EXJADE should not be chewed or swallowed whole, and should not be taken at the same time as aluminum-containing antacids (for example, Maalox?).

Other Medicines and EXJADE: If you are taking other medicines, such as birth control pills, diabetes drugs, seizure drugs, cholesterol-lowering drugs, or medicine for serious illnesses, talk to your doctor. EXJADE may affect how these drugs work.

Hearing and Vision Tests: You may also receive a hearing or vision test prior to receiving EXJADE and yearly thereafter. Your dose of EXJADE may be changed if needed based on the results of these tests.

Common Side Effects: The most commonly reported side effects related to EXJADE in clinical trials were mainly nausea, vomiting, diarrhea, stomach pain, increases in kidney lab values, and skin rash. These side effects were mild to moderate in severity. If you experience diarrhea or vomiting you should ensure that you continue to drink fluids.

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 详细处方信息以本药内容附件PDF文件(201221918144036.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-04-09
附件:






201221918144036.PDF    

 
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