药品名称：Levemir
通用名称：注射用地特胰岛素
生产商家：诺德公司（NovoNordisk）
适应证：
Levemir现在可用于两岁至成年的1型糖尿病患者及2型糖尿病成人患者。
世界糖尿病领域的领头羊--诺和诺德公司（Novo Nordisk）今天宣布，美国食品药品管理局（FDA）已经批准Levemir（注射用地特胰岛素[rDNA 来源]）应用于2到5岁1型糖尿病患儿。随着在儿科适应症的扩展，Levemir现在可用于两岁至成年的1型糖尿病患者及2型糖尿病成人患者。
FDA的批准意味着Levemir成为首个及唯一一个适用于这一低龄患者群体的基础胰岛素类似物。
“治疗那些患有I型糖尿病的低龄儿童时，我们的最大挑战及最优先考虑的是安全性及减少低血糖风险” <小儿糖尿病>Pediatric Diabetes主编 Dr. Mark Sperling, MD说，“由于FDA的批准，Levemir成为治疗患有1型糖尿病低龄患者方法中的一员，我们对此特别欢迎”
每年有超过13000名年轻人被诊断患有1型糖尿病。患有1型糖尿病的低龄儿童极有可能罹患严重的低血糖并成为急性糖尿病综合症的高位人群。
FDA的决定基于有数据表明与中效低精蛋白胰岛素（NPH）相比，Levemir对于患有1型糖尿病的2-5岁儿童(n=82)同样有效。组间平均糖化血红蛋白（HbA1c）相似（Levemir 8.2%，作为基准的NPH 为8.1%,一年分别为8.1% 和 8.3%,）。根据2012年美国糖尿病协会指导手册的建议，低于6岁儿童的A1c应小于8.5%。
该数据具体并分门别类地表明，2到5岁1型糖尿病患者接受Levemir及速效胰岛素类似物NovoLog(门冬胰岛素注射剂[rDNA 来源] )联合治疗时发生低血糖现象比例低，较NPH与NovoLog联合应用为少（24小时，50.6 vs. 78.3每患每年）。应用Levemir治疗的患者未出现严重低血糖症状，而应用NPH的患者则出现6例报告。
该研究中，应用Levemir出现副作用报告的比例稍低于NPH(69.0% vs. 77.5%)；其中多数被认为与实验结果无关。两个治疗组中最常见的严重副作用(Levemir 组: 12%, NPH 组: 15%)现象为感染（肠胃炎）与胃肠道紊乱（消化不良）。
2011年9月，欧洲人用医药委员会(CHMP)同样支持扩展Levemir在2到5岁患有1型糖尿病患儿的应用。

Generic Name: insulin detemir (IN su lin DE te mir)
Brand Names: Levemir, Levemir FlexPen
Dosage Form: injection, solution
FULL PRESCRIBING INFORMATION
Generic Name: insulin detemir (IN su lin DE te mir)
What is Levemir?
Levemir (insulin detemir) is a man-made form of insulin, a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Levemir is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.
Levemir is used to treat type 2 diabetes in adults.
Levemir is also used to treat type 1 diabetes in adults and children who are at least 2 years old.
Levemir may also be used for purposes not listed in this medication guide.
Important information about Levemir
You should not use Levemir if you are allergic to insulin detemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).
Many other drugs can potentially interfere with the effects of Levemir. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. An insulin overdose can cause life-threatening hypoglycemia. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Be sure your family and close friends know how to help you in an emergency.
Before using Levemir?
You should not use Levemir if you are allergic to insulin detemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).
To make sure you can safely take Levemir, tell your doctor if you have liver or kidney disease, or if you are taking any other medications.
FDA pregnancy category B. Levemir is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin detemir 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.
See also: Levemir pregnancy and breastfeeding warnings (in more detail)
How should I use Levemir?
Use Levemir exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Levemir is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. If you use this medicine once daily, use the injection at your evening meal or at bedtime. If you use the medicine twice daily, use your evening dose at least 12 hours after your morning dose.
Your doctor may want you to use a short-acting insulin in addition to Levemir. Always inject your insulins separately. Do not mix or dilute Levemir with any other insulin. Do not use an insulin pump.
Levemir should be thin, clear, and colorless. Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your doctor for a new prescription. Choose a different place in your injection skin area each time you use this medication. Do not inject Levemir into the same place two times in a row.
Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.
Needles may not be included with the injection pen. Ask your doctor or pharmacist which brand and type of needle to use with the pen. Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. Be sure your family and close friends know how to help you in an emergency.
Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.
Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.
Your doctor may want you to stop taking Levemir for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.
Ask your doctor how to adjust your Levemir dose if needed. Do not change your medication dose or schedule without your doctor's advice. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials or injection pens may also be stored at room temperature for up to 42 days, away from heat and bright light. Storing vials after your first use: Keep the "in-use" vials in a refrigerator or at room temperature.
Storing injection pens after your first use: Keep the "in-use" injection pens at room temperature. Do not refrigerate.
Throw away any Levemir kept at room temperature and not used within 42 days.
Do not freeze Levemir, and throw away the medication if it has become frozen.
What happens if I miss a dose?
Follow your doctor's directions if you miss a dose of insulin. It is important to keep Levemir on hand at all times. Get your prescription refilled before you run out of medicine completely.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.
Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).
What should I avoid while using Levemir?
Do not change the brand of insulin detemir or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. It can lower your blood sugar.
Levemir side effects
Get emergency medical help if you have any of these signs of insulin allergy to Levemir: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.
Call your doctor at once if you have a serious side effect such as:
•itching, swelling, or redness where you inject Levemir;
•swelling in your hands or feet; or
•low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).
Less serious Levemir side effects may include:
•thickening of the skin where you inject Levemir;
•weight gain;
•mild headache, back pain;
•stomach pain; or
•flu symptoms, or cold symptoms such as stuffy nose, sneezing, sore throat.