产地国家：美国

处方药：是

所属类别： 10克/包 20包/盒

包装规格： 10克/包 20包/盒

计价单位：盒

生产厂家英文名：Wellstat Therapeutics

原产地英文商品名：VISTOGARD oral granule 10g/packets 20packets/box

原产地英文药品名：uridine triacetate

中文参考商品译名：VISTOGARD口服颗粒 10克/包 20包/盒

中文参考药品译名：尿苷三乙酸酯

简介：

近日，美国FDA批准尿苷三乙酸酯（uridine triacetate；商品名：Vistogard）用于接受癌症治疗药物氟尿嘧啶或卡培他滨过量治疗的成年及儿童的急症治疗，或用于接受这些癌症药物治疗后四天内发生某些严重或危及生命毒性的患者。FDA的药物评价和研究中心血液学和肿瘤学办公室主任Richard Pazdur, M.D.说:癌症治疗的选择不仅取决于哪种药可能是最有效和良好的耐受性，还取决于确保正确的剂量在适当的时间间隔。虽然罕见，无意识的过量是可能发生的，今天的批准是一种这类疗法的第一种批准，可以挽救那些因这些化疗药物的过量或产生危及生命的药物毒性的患者.Vistogard以口服吸收，阻止氟尿嘧啶化疗所致细胞损伤和细胞死亡。当服用过量 (无论有症状) 或早发性 (内四天) 后，病人应尽快服用。批准日期：2015年9月4日 公司：Wellstat TherapeuticsVISTOGARD（尿苷三乙酸[uridine triacetate]）颗粒剂,供口服使用美国最初批准：2015年

作用机理：尿苷三醋酸酯尿苷的乙酰药。口服给药后，尿苷三醋酸酯是由存在于整个机体非特异性酯酶去乙酰化，在循环产生尿苷。尿苷竞争性抑制引起氟尿嘧啶细胞损伤和细胞死亡。氟尿嘧啶是细胞毒性抗代谢物做了与核酸代谢干涉在正常细胞和癌细胞。细胞anabolize氟尿嘧啶到细胞毒性中间体5-氟-2'-脱氧尿苷-5'-一磷酸（FdUMP的）和5-氟尿苷三磷酸（FUTP）。FdUMP的抑制胸苷酸合成酶，阻断胸苷合成。胸苷所需的DNA复制和修复。尿苷没有在DNA中发现的。氟尿嘧啶细胞毒性的第二源是其代谢物，FUTP的掺入，成RNA。 FUTP的这种掺入RNA正比于全身氟尿嘧啶曝光。从VISTOGARD衍生过量的循环尿苷被转换成三磷酸尿苷（UTP），其与FUTP掺入RNA竞争。

适应症和用法：VISTOGARD®的适应症为成人和儿童患者的抢救嘧啶类似物：无论以下症状存在的氟尿嘧啶或卡培他滨过量，或谁表现出早发，严重或危及生命的毒性影响心脏或中枢神经系统，和/或早发，异常严重不良反应96小时内（例如，胃肠道毒性和/或中性粒细胞减少）按照氟尿嘧啶的端部或卡培他滨管理。

使用限制：不推荐用于非紧急处理用氟尿嘧啶或卡培他滨有关的因为它可能会减弱的合成药物的疗效的不良反应的VISTOGARD。安全性和VISTOGARD的功效发起超过96小时，以后氟尿嘧啶或卡培他滨给药结束尚未确定。

用法用量：推荐用量成年人10克（1个分组）口服，每6小时20个剂量，而不考虑膳食。儿科：6.2克/体表面积（不超过每剂量为10克），口服，每6小时20个剂量平方米，不考虑膳食。管理儿科：测量使用一个尺度精确到至少0.1克，或带刻度的茶匙精确至¼茶匙剂量。混合各剂量VISTOGARD用3至4盎司的软食物：如苹果酱，布丁或酸乳酪和混合后30分钟内摄取。不要嚼颗粒VISTOGARD。喝至少4盎司的水。如果患者2小时服用剂量VISTOGARD的内发生呕吐，呕吐发作后尽快启动下一个完整的剂量。辖下一个剂量在定期安排时间。如果患者在计划的时间错过了剂量，辖尽快做VISTOGARD的剂量。辖下一个剂量在定期安排时间。经由鼻胃管（NG管）或胃造口管（G-管）管理VISTOGARD在必要时（例如，严重的粘膜炎或昏迷）。

剂型和规格：口服颗粒剂：10克包

禁忌症：无。

警告和注意事项：无。

不良反应：不良反应的接收VISTOGARD包括呕吐，恶心和腹泻病人> 2％发生的。

储存：室温USP，25℃（77°F）偏移允许15°〜30℃（59°〜86°F）。

英文版说明书：

Uridine Triacetate (Vistogard®)Classification: pyrimidine analogAbout Uridine Triacetate (Vistogard®)Uridine triacetate is a pyrimidine analog. Uridine stops cell damage and cell death that is caused by fluorouracil. It is used to treat a fluorouracil or capecitabine overdose or for patients who have early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system or unusually sever adverse reactions including gastrointestinal toxicity and/or neutropenia (low white blood cell count). It must be given within 96 hours of the end of fluorouracil or capecitabine administration. It should not be used for non-emergent treatment of side effects because it may lessen the effects of the drugs.How to Take Uridine TriacetateThe first dose of uridine triacetate should be administered within 96 hours of the end of flurouracil or capecitabine administration. Your dose will be based on your body size and your provider will tell you how much to take.•Uridine triacetate comes in a granule form, to be taken every 6 hours for 20 doses.•The granules should be mixed with 3 to 4 ounces of a soft food (applesauce, pudding, yogurt).•Take the dose within 30 minutes of mixing with food.•Do not chew the granules.•Drink at least 4 ounces of water with the dose.•If a patient vomits within 2 hours of taking the dose another dose should be taken as soon as possible and the next dose given at the regularly scheduled time.•If you miss a dose, take a dose as soon as possible, and take the next dose at your regularly scheduled time.•Uridine triacetate can also be administered through a nasogastric or gastric tube when necessary.Storage and HandlingStore your medication in the original, labeled package at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.Where do I get this medication?Uridine triacetate is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home. You may receive this medication while in the hospital if your side effects warrant hospital care.Insurance InformationThis medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.Possible Side Effects of Uridine TriacetateKeep in mind that many of the side effects you will be experiencing while taking uridine triacetate may be side effects of the fluorouracil or capecitabine previously received, and not the uridine triacetate. Talk to your doctor or nurse about the side effects you are experiencing and any recommendations. They can help you decide what will work best for you. These are the most common side effects:Nausea and/or VomitingTalk to your doctor or nurse so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try antacids, (e.g. milk of magnesia, calcium tablets such as Tums), saltines, or ginger ale to lessen symptoms.Nausea and vomiting can also be a side effect of fluorouracil and capecitabine. It is important to call your doctor or nurse if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.DiarrheaYour oncology team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses on non-alcoholic, un-caffeinated fluid a day to prevent dehydration. Diarrhea can also be a side effect of fluorouracil. Notify your provider if you experience any diarrhea.Reproductive ConcernsIt is not known whether exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and .