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巯嘌呤,巯嘌呤混悬剂Mercaptopurine (Purixan Oral Suspension 20mg/mL 100ml)

药店国别:

产地国家:美国

处方药:

所属类别: 20毫克/毫升 100毫升/瓶

包装规格: 20毫克/毫升 100毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Rare Disease Therapeutics, Inc.

原产地英文商品名:PURIXAN 20mg/mL 100ml oral solution

原产地英文药品名:suspension

中文参考商品译名:PURIXAN混悬剂 20毫克/毫升 100毫升/瓶

中文参考药品译名:巯嘌呤

曾用名:

简介

近日,美国食品药品监督管理局(FDA)批准了一款巯嘌呤的口服混悬剂Purixan,用于治疗急性淋巴细胞性白血病(ALL)。

巯嘌呤在美国以外市场以Xaluprine为商品名上市,但Nova表示,由于其片剂药物需要根据患者(多数为儿童)人体表面积来调整给药剂量,所以导致问题频频出现。

该公司在一份声明中这样表示:

“口服混悬剂相比片剂,可以提供更加一致的吸收,允许精确的2mg个体化给药。

”支持该药物批准的临床试验证明,Purixan与巯嘌呤片剂具有生物等效性。

欧洲药品管理局(EMA)于2012年3月推荐了这款药物,由于其治疗相对罕见的ALL,该药物在美国被授予了孤儿药资格。

根据美国癌症协会提供的信息,2014年美国将有6020名新的ALL患者被确诊,大约有1440名患者会死于这种疾病,这种疾病始于骨髓中的白细胞,在儿童中较为常见。

Nova临床开发主管Hussain Mulla博士说:“我们对于FDA的批准感到非常自豪,这将会有助于改善全球儿童癌症患者的治疗。

”批准日期:2014年5月23日

公司:Rare Disease Therapeutics, Inc.PURIXAN(巯基嘌呤[mercaptopurine])口服混悬液

初始美国批准:1953年

最近的重大变化剂量和用法,维持治疗:02/2018

剂量和给药,TPMT和/或TPMT患者的剂量NUDT15缺陷:02/2018

警告和注意事项,骨髓抑制:02/2018

作用机制

经由巯基嘌呤激活而发生的次黄嘌呤 – 鸟嘌呤磷酸核糖转移酶(HGPRTase)和几种酶toform 6-硫鸟嘌呤核苷酸(6- TgNs)。将6-TGN掺入核酸(代替嘌呤碱基)导致细胞周期残留和细胞死亡。巯嘌呤与次黄嘌呤和鸟嘌呤竞争HGPRTase,并且本身转化为硫代肌苷酸(TIMP)。

此细胞内核苷酸抑制几种反应涉及肌苷酸(IMP),includingthe IMP转化为黄苷酸(XMP)和IMP的转化通过腺苷酸琥珀酸到腺苷酸(AMP)(SAMP)。另外,通过TIMP的甲基化形成6-甲硫基肌苷酸(MTIMP)。既TIMP和MTIMP已经报道抑制谷氨酰胺-5-磷酸核糖焦磷酸酰胺转移酶,唯一的嘌呤核糖核苷酸合成的去novopathway的第一个酶。

实验表明,放射性标记的巯嘌呤可以以脱氧硫代鸟苷的形式从DNA中回收。一些巯基被转换由肌苷的连续动作(IMP)脱氢酶和xanthylate(XMP)氨基酶,转化TIMP tothioguanylic酸(TGMP)至核苷酸6-硫鸟嘌呤(6-TG)的衍生物。

适应症和用法

PURIXAN(巯基嘌呤)是一种核苷代谢抑制剂,用于治疗急性淋巴细胞白血病(ALL)患者,作为联合维持方案的一个组成部分。剂量和用量多剂联合化疗维持方案中PURIXAN的起始剂量为1.5至2.5mg/kg(50至75mg/m2),作为单日剂量。使用绝对中性粒细胞计数来引导。

剂量形式和强度口服混悬液:2000mg/100mL(20mg/mL)

禁忌症:

警告和注意事项

骨髓抑制:监测全血细胞计数(CBC)并调整PURIXAN的剂量以治疗严重的中性粒细胞减少症和血小板减少症。评估重复严重骨髓抑制患者的硫嘌呤甲基转移酶(TPMT)或核苷酸二磷酸酶(NUDT15)缺乏症。具有纯合TPMT或纯合NUDT15缺陷的患者需要大量减少PURIXAN的剂量。

肝毒性:监测转氨酶和胆红素。保持或调整PURIXAN的剂量。

免疫抑制:由于与ALL维持化疗相关的免疫抑制,存在感染活病毒疫苗的风险。免疫功能低下儿童的免疫指南。

胚胎毒性:PURIXAN可导致胎儿伤害。告知女性对胎儿有潜在风险。

治疗相关恶性肿瘤:发生了肝脾T细胞淋巴瘤的侵袭性和致命性病例。

噬血细胞淋巴组织细胞增多症:及时监测和治疗;停止PURIXAN。

不良反应

最常见的不良反应(> 20%的患者)是骨髓抑制,包括贫血,中性粒细胞减少,淋巴细胞减少和血小板减少。 5-20%的患者发生不良反应包括厌食,恶心,呕吐,腹泻,不适和皮疹。

药物相互作用

别嘌呤醇:避免使用。

华法林:PURIXAN可能抑制抗凝血作用。

包装提供/存储和处理

提供PURIXAN(巯基嘌呤)口服混悬液2000mg/100mL(20mg/mL)是一种粉红色至棕色粘稠液体,提供带玻璃的多剂量瓶,带有防儿童帽。此外,还提供了一种压入式瓶适配器和两个口服点胶环(1 mL和1mL)。每个纸箱NDC 62484-0020-2包含1瓶PURIXAN NDC 62484-0020-1。存储和处理PURIXAN包装有防儿童帽。

将PURIXAN存放在59º至77ºF(15º至25ºC)之间,在干燥的地方。不要储存在25°C以上。将口服分配注射器存放在干净的地方,并加入药物。

PURIXAN口服混悬液应在打开瓶子后8周内使用。 8周后处理(扔掉)任何未使用的药物。请勿在'EXP'后使用纸箱和瓶子上标明的失效日期。保持瓶子紧闭。避免药物腐败,减少意外溢出的风险。PURIXAN是一种细胞毒性药物。遵循特殊处理和处理程序。

英文版说明

Package_Insert.pdfPURIXAN(mercaptopurine) oral suspensionInstructions for UseVIDEO: HOW TO USE PURIXAN®PURIXAN® (pure-ee-zan)(mercaptopurine)oral suspension20 mg/mLRead these Instructions for Use before you start taking PURIXAN, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.Important information about measuring PURIXAN oral suspensionAlways use the oral dispensing syringe provided with your PURIXAN oral suspension to make sure you measure the right amount.You will be provided:1 bottle of PURIXAN oral suspension1 bottle adapter2 oral dispensing syringes (one 1 mL and one 5 mL)If you did not receive an oral dispensing syringe with your PURIXAN oral suspension, ask yourpharmacist to give you one.You will also need disposable gloves.Dispensing InstructionsBefore you use PURIXAN oral suspension for the first time:Wash your hands well with soap and water before and after administering a dose.Put on disposable gloves before handling PURIXAN.Shake the bottle vigorously for at least 30 seconds to make sure that the medicine is well mixed (See Figure A).Remove the child-resistant bottle cap (see Figure B).Push the ribbed end of the bottle adapter into the neck of the bottle until it is firmly in place. The bottom edge of the adapter should fully contact the top rim of the bottle (See Figure C). Do not remove the adapter from the bottle after it is inserted.To prepare a dose of PURIXAN oral suspension:Hold the bottle upright. Remove the bottle cap by turning in the direction of the arrow (See Figure B).Push the tip of the oral dispensing syringe into the hole in the bottle adapter (See Figure D and Figure E).Turn the bottle upside down (See Figure F).Pull back slowly on the plunger of the oral dispensing syringe to withdraw the prescribed dose of PURIXAN. Pull the plunger back to the mL mark on the syringe that corresponds to the dose prescribed (Figure F). If you are not sure about how much medicine to draw into the oral dispensing syringe, always ask your doctor, pharmacist or nurse for advice.Leave the oral dispensing syringe in the bottle adapter and turn the bottle right-side up. Place the bottle onto a flat surface. Hold the oral dispensing syringe by the barrel and carefully remove it from the adapter. Do not hold the oral dispensing syringe by the plunger, because the plunger may come out.Place the tip of the oral dispensing syringe in your mouth and aim the tip toward the inside of your cheek.Gently squirt the PURIXAN oral suspension into your mouth by pushing on the plunger until the oral dispensing syringe is empty. Swallow the medicine.Do not forcefully push on the plunger.Do not squirt the medicine to the back of your mouth or throat. This may cause you to choke.Remove the oral dispensing syringe from your mouth.Swallow the dose of oral suspension then drink some water, making sure no medicine is left in your mouth.Put the cap back on the bottle with the adapter left in place. Close the cap tightly.Wash the oral dispensing syringe with warm soapy water and rinse well. Hold the oral dispensing syringe under water and move the plunger up and down several times to make sure the inside of the oral dispensing syringe is clean. Let the oral dispensing syringe dry completely before you use it again fordosing. Do not throw away the oral dispensing syringe after use.What are the ingredients in PURIXAN oral suspension?Active ingredient: mercaptopurineInactive ingredients: xanthan gum, aspartame, concentrated raspberry juice, sucrose, ethylparahydroxybenzoate sodium, methyl parahydroxybenzoate sodium, potassium sorbate, sodium hydroxide, and purified water.How should I store PURIXAN oral suspension?PURIXAN comes in a bottle with a child-resistant cap.Store PURIXAN between 59ºF to 77ºF (15ºC to 25ºC), in a dry place. Do not store above 25°C.Store the oral dispensing syringe in a clean place, with the medicine.PURIXAN oral suspension should be used within 8 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 8 weeks.Do not use after the expiry date which is stated on the carton and the bottle after ‘EXP’.Keep the bottle tightly closed to prevent spoilage of the medicine and reduce the risk of accidental spillage.Keep PURIXAN oral suspension and all medicines out of the reach of children, preferably in a locked cupboard. If a child accidentally takes PURIXAN, it could cause death. Ask your pharmacist how to dispose of (throw away) PURIXAN that is no longer needed.How should I dispose of PURIXAN?Ask your pharmacist how to dispose of PURIXAN that is expired or no longer required. Medicines should not be disposed of via wastewater or household waste.How do I clean up spillage of PURIXAN?Use appropriate personal protective equipment (disposable gloves and eye protection). Mop up and contain spill material in a compatible container. Wash your hands thoroughly afterwards.What do I do if PURIXAN came into contact with skin, eyes, or clothes?Remove and launder contaminated clothing.Wash skin or eyes immediately with water.Contact with skin or eyes can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. If symptoms appear, seek medical attention.This Instructions for Use has been approved by the U.S. Food and Drug Administration.

 

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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