美国FDA批准Sancuso治疗化疗所致恶心呕吐
日前，美国DA批准全球第一种经皮吸收的5-HT-3受体阻断剂Sancuso，用于治疗化疗引起的恶心呕吐（CINV）。
这种新型药物通过一种粘着剂固定于上臂皮肤，缓慢持续释放止吐药物成分格拉司琼（Granisetron），可保持有效血药浓度达5天之久。
美国FDA做出这一批准，是基于一项多中心的3期随机、双盲、对照试验结果。该试验显示，Sancuso与每日1次口服格拉司琼具有相似的疗效、耐受性和安全性。
目前，约1/2~2/3的接受化疗患者会发生CINV，不仅降低患者生活质量，而且会因引起脱水、营养不良、电解质紊乱等并发症而使患者被迫中止化疗。这一新型药物将有助于化疗患者更好地应对CINV，而且尤其适用于吞咽困难或对口服药物不能很好耐受的患者。

【药物名称】 格拉司琼

【英文名称】 Granisetron

【功能主治】 高选择性的5~HT3受体拮抗剂，通过拮抗化学感受区及外周迷走神经末梢的5~HT3受体，抑制恶心、呕吐的反射。 用于预防和治疗抗肿瘤药物化疗、放疗和手术后引起的恶心和呕吐。 

【副 作 用】 可能有头痛、倦耽发热、便秘等，偶有短暂性无症状转氨酶增高。 

【注意事项】 (1)胃肠道梗阻者、对本品过敏者、小儿禁用。(2)孕妇、哺乳期妇女慎用。

【原产地英文商品名】:SANCUSO 24 HR PATCH 3.1mg/patch
【原产地英文药品名】:GRANISETRON
【中文参考商品译名】:SANCUSO 24小时粘剂 3.1毫克/粘剂
【中文参考药品译名】:格拉司琼
【生产厂家中文参考译名】:STRAKAN
【生产厂家英文名】:STRAKAN

Sancuso

Generic Name: granisetron (transdermal) (gra NIS e tron)
Brand Names: Sancuso

What is Sancuso?
Sancuso blocks the actions of chemicals in the body that may cause nausea and vomiting.

Sancuso transdermal (skin patch) is used to prevent nausea and vomiting caused by cancer chemotherapy.

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

Important information about Sancuso
You should not use Sancuso if you are allergic to granisetron.
Before using Sancuso, tell your doctor if you have a stomach or intestinal disorder, if you have recently had stomach or intestinal surgery, or if you have ever had an allergic reaction to any type of medicated skin patch. You may need a dose adjustment or special tests to safely use Sancuso.

Avoid exposing the skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the Sancuso skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch. Do not use Sancuso during a time when you are not having chemotherapy, unless your doctor has told you to.

What should I discuss with my healthcare provider before using Sancuso?
You should not use Sancuso if you are allergic to granisetron.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Sancuso, tell your doctor if you have:
a stomach or intestinal disorder;
if you have recently had stomach or intestinal surgery; or
if you have ever had an allergic reaction to any type of medicated skin patch.

FDA pregnancy category B. Sancuso is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use Sancuso on anyone younger than 18 years old.

How should I use Sancuso?
Use Sancuso exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Apply the Sancuso skin patch 24 to 48 hours before your chemotherapy is scheduled to start. To use the patch, open the sealed pouch and remove the protective liner. Apply the transdermal patch to a clean, dry area on the outer side of your upper arm. Avoid placing the patch on skin that is red, irritated or damaged.

Press the patch onto the skin and press it down firmly with your fingers. Make sure the patch is well sealed around the edges.

Leave the patch in place and wear it for at least 24 hours after your chemotherapy ends. You may continue wearing the Sancuso skin patch for up to 7 days if needed, depending on your chemotherapy schedule. Follow your doctor's instructions.

Do not cut or trim the Sancuso skin patch.
If the patch falls off, try sticking it back on. If it does not stay on, replace it with a new one and wear it for the rest of your patch-wearing time. Do not change your schedule, even if you apply a new patch to replace one that has fallen off.

After removing a patch, fold it in half so it sticks together and throw it away in a place where children or pets cannot get to it.

Do not use Sancuso during a time when you are not having chemotherapy, unless your doctor has told you to. Keep each Sancuso skin patch in its sealed pouch until you are ready to use it. Store the pouches at room temperature away from moisture, heat, and light.

What happens if I miss a dose?
Call your doctor for instructions if you forget to apply a Sancuso skin patch at least 24 hours before your chemotherapy is scheduled to start. Do not use extra patches to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
An overdose of Sancuso is not expected to produce life-threatening side effects.

What should I avoid while using Sancuso?
Avoid exposing the Sancuso skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the Sancuso skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch.

Sancuso side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Remove the skin patch and call your doctor at once if you have a serious side effect such as:
severe redness, itching, swelling, or other irritation where the patch is worn;
uneven heart rate;
fever, pale skin, easy bruising or bleeding; or
feeling like you might pass out.

Less serious Sancuso side effects may include:
diarrhea, constipation;
nausea, vomiting, stomach pain;
loss of appetite;
headache;
mild itching or skin irritation where the patch is worn;
dizziness, drowsiness, anxiety;
sleep problems (insomnia); or
temporary hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sancuso?
There may be other drugs that can interact with Sancuso. 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.

Where can I get more information?
Your pharmacist can provide more information about Sancuso.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sancuso only for the indication prescribed.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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 appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

SANCUSO