美国FDA批准ProStrakan Group公司新颖受专利保护的格拉司琼透皮贴片（granisetron，Sancuso）上市，持续长达5日预防化疗引起的恶心和呕吐。本品剂量规格：格拉司琼34.3 mg/52 cm2（贴片），每24小时释放3.1 mg药物。化疗前24小时将透皮贴片贴于清洁、干燥、完整健康上臂皮肤上，根据化疗给药方案可保留7日。

本品是世界上首个获准上市的5HT3受体阻断剂透皮贴片产品，上市后仅在美国的销售额就可达13亿美元。本品作为透皮贴片，为严重恶心和呕吐的癌症患者提供了一种不需注射不需口服的新给药途径。ProStrakan Group公司在国内开发了本品，从立题到上市花费了5年。

本品透皮贴片稳定地将5HT3受体阻断剂格拉司琼释入血流达7日。本品显示预防正在进行化疗的患者恶心和呕吐不良反应的疗效可与格拉司琼口服制剂相媲美。其优点是提供简便的透皮贴片的使用方法，避免以往一日需多次注射给药因而减少可能感染的危险，或避免以往一日需多次吞咽多粒口服固体制剂（癌症患者由于口腔黏膜炎常难以服药）。

美国FDA批准本品上市用于化疗引起的恶心和呕吐是基于与一日1次格拉司琼2 mg口服制剂比较疗效、患者耐受性和安全性的多中心随机双盲双安慰剂对照Ⅲ期临床研究的结果。此研究共收治641例中等至严重一日多次有催吐作用的化疗患者，符合与格拉司琼口服制剂相比无侵入性完全控制化疗引起恶心和呕吐的主要终点。完全控制的定义为无呕吐和（或）干呕、无轻度恶心和最近化疗后首次使用Sancuso透皮贴片直至24小时不再使用药物。最常见的不良反应是便秘。作为用于批准部分人群，该公司准备进行一些批准后的临床研究，包括对儿童和老年患者的评价

sancuso（格拉司琼透皮系统）

最初美国批准：2008

ProStrakan, Inc.

适应症
sancuso是5 - 羟色胺亚型3（5-HT3）受体拮抗剂预防恶心和呕吐表明，在接受中等和/或高致吐化疗，连续5天的患者。
 
剂量和用法
适用于一个单一的透皮系统（补丁）上的外臂化疗前的24小时最低。该补丁可应用于化疗前最多48小时是适当的。删除补丁化疗结束后至少24小时。该补丁可以穿至7天，取决于化疗的时间。
 
剂型和优势
52平方厘米补丁包含34.3毫克格拉提供3.1毫克，每24小时。

禁忌
过敏格拉或任何补丁的组件
 
注意事项：
格拉可能掩盖一个渐进性肠梗阻和/或胃扩张引起的基本条件。
轻度应用部位反应时有发生;删除补丁，如果发生严重反应或全身皮肤反应。
避免自然或人工太阳光直接应用现场曝光涵盖服装，而穿补丁和取出后10天。

不良反应
最常见的不良反应是便秘。
 
药物相互作用
没有临床相关的药物相互作用已在临床研究报告与Sancuso。
 
在特殊人群中使用
只有显然需要在怀孕期间使用。
使用管理哺乳期妇女时的注意事项。
在儿科患者中的安全性和有效性尚未确立。
临床研究的Sancuso不包括65岁的科目，并在有足够数量，以确定他们是否年轻患者不同反应

日期：09/2011

Medication name

Generic name: Granisetron - Transdermal
Pronunciation: (gra-NIS-e-tron)
Brand name(s): Sancuso
Uses
This medication is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It works by blocking one of the body's natural substances (serotonin) that can cause vomiting.
How to use
Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow all instructions for how to properly apply and use the patch. Do not cut the patch into smaller sizes. Do not use the patch if it appears broken, cut, or damaged. If you have any questions, consult your doctor or pharmacist.Apply this medication to the skin, usually 1 to 2 days (24 to 48 hours) before your chemotherapy treatment or as directed by your doctor. Do not open the sealed pouch until you are ready to use the patch. Open the pouch and remove the patch from the protective liner. Apply the patch as directed to a clean and dry area on the outside part of your upper arm. Do not apply the patch to recently shaved or oily/red/irritated/broken areas of skin or to areas where you have applied skin products such as creams or lotions. You can bathe and shower with the patch on. Wash your hands with soap and water after each application.Wear the patch during your chemotherapy treatment until at least 24 hours after you finish treatment. Do not wear the patch for more than 7 days in a row. Consult your doctor for more details on how long you should wear your patch.If the patch does not stick well, apply medical tape or surgical bandages to the edges of the patch to keep the patch in place. Do not completely cover the patch.When it is time to remove the patch, peel it off gently. Fold it in half with the sticky sides together, and discard in the trash away from children and pets. Do not reuse the patch. Wash the application site and your hands with soap and water. The application site may have some mild redness, which should go away within 3 days. Contact your doctor if the redness continues after 3 days.Use this medication exactly as directed to get the most benefit from it. Do not use more medication than prescribed. Tell your doctor if nausea occurs with your chemotherapy treatment.
Precautions
Before using granisetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as ileus, swelling).This medication may be affected by sunlight or may make the application site more sensitive to sunlight. While wearing the patch, keep it covered (such as under clothing) to avoid exposing it to sunlight and sunlamps. Avoid tanning booths. After removing the patch, keep the application site covered for another 10 days.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.This drug should not be used with the following medication because a very serious interaction may occur: apomorphine.If you are currently using the medication listed above, tell you doctor or pharmacist before starting granisetron.Before using this medication, tell your doctor of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Side effects
Constipation may occur. If this effect persists or worsens, tell your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if this unlikely but serious side effect occurs: stomach/abdominal pain or swelling.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Missed dose
Tell your doctor if you miss your dose or did not use your dose at the correct time before your scheduled chemotherapy appointment. Your treatment may need to be rescheduled.
Overdose
This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
Notes
Do not share this medication with others.
Storage
Store the patch at room temperature between 68-77 degrees F (20-25 degrees C) in the original sealed pouch away from heat. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not open the pouch until you are ready to use the patch. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Photos by medication strength
Click the "Photos" link to see sample photographs for a specific medication strength.

Common strengths
Sancuso 3.1 mg/24 hour Transderm Patch
*The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist.
Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised May 2010 Copyright(c) 2010 First DataBank, Inc.