利拉鲁肽（商品名Victoza，诺和诺德公司研发）是第一个用于治疗2型糖尿病的每日使用1次的人胰高糖素样肽1（GLP-1）类似物。继该药在欧盟和日本获准后，利拉鲁肽于近日获得美国FDA批准上市。 　该药适用于与饮食和运动联合治疗以改善成人2型糖尿病患者的血糖控制情况，可作为单药治疗，也可与常用处方口服降糖药联合使用。 　　LEAD项目（利拉鲁肽的Ⅲ期临床试验）由一系列多国、随机、对照、双盲研究组成，评价了利拉鲁肽单药治疗以及与一种或两种口服降糖药联合治疗2型糖尿病的疗效。结果显示，与活性对照药物（如磺脲类和噻唑烷二酮类药物）相比，其降糖效果更具优势或相当。而且，LEAD项目研究结果显示，利拉鲁肽组患者低血糖风险较低且有体重减轻。 If you are having problems using your Victoza® pen, call toll free 1-877-484-2869 or visit victoza.com First read the Medication Guide that comes with your Victoza® pen and then read these Patient Instructions for Use for information about how to use your Victoza® pen the right way. These instructions do not take the place of talking with your healthcare provider about your medical condition or your treatment. Your Victoza® pen contains 3 mL of Victoza® and will deliver doses of 0.6 mg, 1.2 mg or 1.8 mg. The number of doses that you can take with a Victoza® pen depends on the dose of medicine that is prescribed for you. Your healthcare provider will tell you how much Victoza® to take. Victoza® pen should be used with Novo Nordisk disposable needles. Talk to your healthcare provider or pharmacist for more information about needles for your Victoza® pen. Important Information Read these instructions carefully before using your Victoza® pen. Failure to follow these instructions completely may result in a wrong dose, a broken pen, or an infection. Do not share your Victoza® pen or needles with anyone else. You may give an infection to them or get an infection from them. Always use a new needle for each injection. Keep your Victoza® pen and all medicines out of the reach of children. If you drop your Victoza® pen, repeat "First Time Use For Each New Pen" (steps A through D). Be careful not to bend or damage the needle. Do not use the cartridge scale to measure how much Victoza® to inject. Be careful when handling used needles to avoid needle stick injuries. You can use your Victoza® pen for up to 30 days after you use it the first time. First Time Use for Each New Pen Step A. Check the Pen Take your new Victoza® pen out of the refrigerator. Wash hands with soap and water before use. Check pen label before each use to make sure it is your Victoza® pen. Pull off pen cap. Check Victoza® in the cartridge. The liquid should be clear, colorless and free of particles. If not, do not use. Wipe the rubber stopper with an alcohol swab. Step B. Attach the Needle Remove protective tab from outer needle cap. Push outer needle cap containing the needle straight onto the pen, then screw needle on until secure. Pull off outer needle cap. Do not throw away. Pull off inner needle cap and throw away. A small drop of liquid may appear. This is normal. Step C. Dial to the Flow Check Symbol Turn dose selector until flow check symbol (--) lines up with pointer. Step D. Prepare the Pen Hold pen with needle pointing up. Tap cartridge gently with your finger a few times to bring any air bubbles to the top of the cartridge. Keep needle pointing up and press dose button until 0 mg lines up with pointer. Repeat steps C and D, up to 6 times, until a drop of Victoza® appears at the needle tip. If you still see no drop of Victoza®, use a new pen and contact Novo Nordisk at 1-877-484-2869. Continue to Step G under "Routine Use" -> Routine Use Step E. Check the Pen Take your Victoza® pen from where it is stored. Wash hands with soap and water before use. Check pen label before each use to make sure it is your Victoza® pen. Pull off pen cap. Check Victoza® in the cartridge. The liquid should be clear, colorless and free of particles. If not, do not use. Wipe the rubber stopper with an alcohol swab. Step F. Attach the Needle Remove protective tab from outer needle cap. Push outer needle cap containing the needle straight onto the pen, then screw needle on until secure. Pull off outer needle cap. Do not throw away. Pull off inner needle cap and throw away. A small drop of liquid may appear. This is normal. Step G. Dial the Dose Victoza® pen can give a dose of 0.6 mg (starting dose), 1.2 mg or 1.8 mg. Be sure that you know the dose of Victoza® that is prescribed for you. Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg). You will hear a "click" every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear. If you select a wrong dose, change it by turning the dose selector backwards or forwards until the correct dose lines up with the pointer. Be careful not to press the dose button when turning the dose selector. This may cause Victoza® to come out. Step H. Injecting the Dose Insert needle into your skin in the stomach, thigh or upper arm. Use the injection technique shown to you by your healthcare provider. Do not inject Victoza® into a vein or muscle. Press down on the center of the dose button to inject until 0 mg lines up with the pointer. Be careful not to touch the dose display with your other fingers. This may block the injection. Keep the dose button pressed down and make sure that you keep the needle under the skin for a full count of 6 seconds to make sure the full dose is injected. Keep your thumb on the injection button until you remove the needle from your skin. Step I. Withdraw Needle You may see a drop of Victoza® at the needle tip. This is normal and it does not affect the dose you just received. If blood appears after you take the needle out of your skin, apply light pressure, but do not rub the area. Step J. Remove and Dispose of the Needle Carefully put the outer needle cap over the needle. Unscrew the needle. Safely remove the needle from your Victoza® pen after each use. Place used needles in a closeable, puncture-resistant container. If your Victoza® pen is empty or if you have been using it for 30 days (even if it is not empty), throw away the used pen. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as an empty detergent bottle), or metal container with a screw top (such as an empty coffee can). Ask your healthcare provider for instructions on the right way to dispose of your used needles, pens, and the container. Do not throw the disposal container in the household trash. Do not recycle. Caring for your Victoza® pen After removing the needle, put the pen cap on your Victoza® pen and store your Victoza® pen without the needle attached. Do not try to refill your Victoza® pen - it is prefilled and is disposable. Do not try to repair your pen or pull it apart. Keep your Victoza® pen away from dust, dirt and liquids. If cleaning is needed, wipe the outside of the pen with a clean, damp cloth. How should I store Victoza? Before use: Store your new, unused Victoza® pen in the refrigerator at 36°F to 46°F (2°C to 8°C). If Victoza® is stored outside of refrigeration (by mistake) prior to first use, it should be used or thrown away within 30 days. Do not freeze Victoza® or use Victoza® if it has been frozen. Do not store Victoza® near the refrigerator cooling element. Pen in use: Store your Victoza® pen for 30 days at 59°F to 86°F (15°C to 30°C), or in a refrigerator at 36°F to 46°F (2°C to 8°C). When carrying the pen away from home, store the pen at a temperature between 59°F to 86°F (15°C to 30°C). If Victoza® has been exposed to temperatures above 86°F (30°C), it should be thrown away. Protect your Victoza® pen from heat and sunlight. Keep the pen cap on when your Victoza® pen is not in use. Use a Victoza® pen for only 30 days. Throw away a used Victoza® pen after 30 days, even if some medicine is left in the pen. For information about Victoza® outside the US, click here. Indications and Usage Victoza® is an injectable prescription medicine that improves blood sugar (glucose) in adults with type 2 diabetes when used with a diet and exercise program. Victoza® is not insulin. It is not known if Victoza® is safe and effective when used with insulin. Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis. Victoza® is not recommended for use in children. Important Safety Information In animal studies, the medicine in Victoza® caused rats and mice to develop thyroid tumors, some of which were cancerous. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. MTC may lead to death. Do not use Victoza® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body. You should tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath while you are taking Victoza® because these may be symptoms of thyroid cancer. Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Certain medical conditions make you more likely to get pancreatitis. Therefore before taking Victoza®, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop taking Victoza® and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. These may be symptoms of pancreatitis. Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea medicine may need to be lowered while taking Victoza®. The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®, but decreases over time in most people. Tell your healthcare provider about all the medicine you take and if are pregnant or breastfeeding. For more information, ask your healthcare provider or pharmacist. Please see Prescribing Information and Medication Guide Victoza® is available by prescription.