产地国家：美国 处 方 药：是 所属类别：100单位/毫升 3毫升/支笔 5支笔/盒 包装规格：100单位/毫升 3毫升/支笔 5支笔/盒 计价单位：盒 生产厂家中文参考译名: 诺和诺德 生产厂家英文名: Novo Nordisk 原产地英文商品名: LEVEMIR FLEXPEN 100UNITS/ML 3MLS/PEN 5PENS/BOX 原产地英文药品名: insulin detemir 中文参考商品译名: 诺和平预填充注射笔 100单位/毫升 3毫升/支笔 5支笔/盒 中文参考药品译名: 地特胰岛素

简介

5月22日，诺和诺德公司(Novo Nordisk)宣布，美国食品药品管理局(FDA)已经批准Levemir(地特胰岛素注射液[rDNA 来源])用于治疗2到5岁1型糖尿病患儿。随着其儿科适应症的扩展，Levemir目前适用于2岁到成年的1型糖尿病患者和成人2型糖尿病患者。 Levemier是一种中性的、可溶的、长效胰岛素类似物。FDA的批准意味着Levemir成为首个和唯一适用于低龄儿童患者群体的基础胰岛素类似物。 适应症 用于治疗糖尿病。 用量用法 本品是可溶性的基础胰岛素类似物，其作用平缓且效果可以预见，作用持续时间长。 与其他胰岛素制剂相比，地特胰岛素治疗引起的体重增加较少。 与其他胰岛素相比较，本品引起夜间低血糖的风险较低，因而可以进行更为积极的剂量调整以实现血糖达标。 以空腹血糖作为评价指标，地特胰岛素较人NPH胰岛素可以更好地控制血糖。 与口服降糖药联合治疗时，推荐地特胰岛素的初始治疗方案为每日一次给药，起始剂量为10U或0.1-0.2U/kg。 不良反应 患者使用本品时发生的不良反应主要与剂量相关，且与胰岛素药理学作用有关。低血糖是常见的不良反应。如果胰岛素使用剂量远高于需要量，就可能发生低血糖。 临床研究表明，大约有6%的患者在使用本品治疗时会发生重度低血糖(指需要他人协助处理的低血糖)。重度低血糖可能导致意识丧失和/或惊厥以及暂时性或永久性脑功能损害甚至死亡。 与人胰岛素相比，地特胰岛素治疗过程中的注射部位反应发生频率更高。这些反应包括注射部位发红，炎症，淤血，肿胀和瘙痒。上述反应多为轻微和一过性的，通常在继续治疗几天至几周内消失。 据估计，大约有12%的患者在使用本品治疗时会发生不良反应。 禁忌 以下患者禁用：对地特胰岛素或者本品中任何其他成份过敏者。 注意事项 本品注射剂量不足或治疗中断时，可能导致高血糖和糖尿病酮症酸中毒(特别是在1型糖尿病患者中易发生)。通常在几小时到几天内，高血糖的首发症状逐渐出现。症状包括口渴、尿频、恶心、呕吐、嗜睡、 皮肤干红、口干、 食欲不振和呼气中有丙酮气味。在1型糖尿病患者中，出现高血糖事件若不予以治疗，最终可能导致有潜在致死性的糖尿病酮症酸中毒。 如果胰岛素的用量远高于胰岛素的需要量时可能出现低血 糖。漏餐或进行无计划、高强度的体力活动， 可导致低血糖。 血糖控制有显著改善的患者(如接受胰岛素强化治疗的患者)，其低血糖的先兆症状会有所改变，应提醒患者注意。对于病程长的糖尿病患者，常见的低血糖的先兆症状可能会消失。 伴有其他疾病，特别是感染和发热，通常患者的胰岛素需要量会增加。 患者换用不同品牌或类型的胰岛素制剂，必须在严格的医疗监控下进行。以下方面的变化均可能导致患者所需剂量改变：胰岛素规格、品牌(生产商)、类型、种类(动物、人胰岛素或人胰岛素类似物)和/或生产工艺(基因重组或动物胰岛素)。患者从其日常使用的胰岛素转用本品时，可能需要调整剂量。剂量调整可能在首次注射或开始治疗的几周或几个月内进行。 和所有的胰岛素治疗一样，使用本品可能会发生注射部位的反应，包括疼痛，瘙痒，荨麻疹，肿胀和炎症。 在指定注射区域连续轮换注射点有助于减少或避免这些反应。这些反应通常在几天或几星期内消失。在罕见情况下，注射部位反应可能需要停止注射地特胰岛素。 由于可能导致重度低血糖，本品绝不能静脉注射。 与皮下注射相比较，肌肉注射吸收更快，吸收量更大。 如果本品与其他胰岛素制剂混合使用，其中之一或者两者的作用特性将会改变。与单独注射相比较，本品与快速起效的胰岛素类似物(如门冬胰岛素)同时使用，其最大作用将会降低和延迟。 本品不能用于胰岛素泵。 运动员慎用。 孕妇及哺乳期妇女用药 本品尚无治疗妊娠或哺乳期妇女的临床经验。 动物生殖研究表明：在胚胎毒性和致畸性方面，本品与人胰岛素没有差异。 建议患有糖尿病的妊娠妇女在整个妊娠期间和计划妊娠时采用 强化血糖控制和监测的方式治疗。胰岛素的需要量通常在妊娠早期减少;而在随后的妊娠中、晚期逐渐增加。分娩后胰岛素 的需要量通常迅速回到妊娠前的水平。哺乳期妇女可能需要调整胰岛素用量和饮食。 儿童用药 本品尚未在6岁以下儿童中进行有效性和安全性的研究。曾在1型糖尿病儿童(6-12岁)和青少年(13-17岁)中进行了本品的药代动力学研究，并与患有1型糖尿病的成人进行了比较。 其药代动力学在这些人群中没有差别。 老年患者用药 在老年受试者与青年受试者间，本品的药代动力 学没有与临床相关的差异。 药物相互作用 已知有多种药物会影响葡萄糖代谢。 可能会减少胰岛素需要量的药物： 口服降糖药，单胺氧化酶抑制剂(MAOI)，非选择性β阻滞剂， 血管紧张素转换酶(ACE)抑制剂，水杨酸盐和酒精。 可能会增加胰岛素需要量的药物： 噻嗪类药物、糖皮质激素、甲状腺激素和β-拟交感神经药、 生长激素和达那唑。

英文版说明书

FDA Approves Levemir® Pregnancy Category Change for Women with Diabetes Levemir® is the first and only basal insulin analog with pregnancy Category B classification Princeton, N.J. (April 02, 2012) /PRNewswire/ — Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for a pregnancy Category B classification, indicating that Levemir®, when used in pregnant women with diabetes, did not increase the risk of harm to the unborn baby. The label update makes Levemir® the first and only basal insulin analog to have this classification. Until this decision, NPH (human insulin) was considered the standard of care for diabetes in pregnancy. Now, Novo Nordisk is the only company that offers a complete portfolio of insulin analogs with a pregnancy Category B classification. The FDA category change was based on a review of a large, randomized controlled trial examining Levemir® in pregnant women with type 1 diabetes. The study compared the safety and efficacy of Levemir® against NPH insulin in the treatment of 310 women. The study found that patients taking Levemir® had similar A1C reduction at gestational week 36 and lower fasting plasma glucose levels at gestational weeks 24 and 36 compared with NPH. Additionally, the study found no differences in the overall safety profile during pregnancy, on pregnancy outcomes or the health of the fetus and newborn. "We are excited that the FDA has granted approval for this new category rating for Levemir®," said Lois Jovanovič, MD, MACE, Chief Scientific Officer, Sansum Diabetes Research Institute in Santa Barbara, California. "For women who are pregnant, diabetes can be extremely challenging; they must be even more diligent and careful when monitoring blood sugar levels than before they were pregnant. This approval provides patients with a long-acting insulin analog option that can help them manage their blood sugar.” In the U.S., there are approximately 1.85 million women of child-bearing age with diabetes. For those who want to get pregnant, this development gives them another option to manage their diabetes. Novo Nordisk now offers its comprehensive line of insulin analog products with a pregnancy Category B classification for use with the FlexPen®, including Levemir® (insulin detemir [rDNA origin] injection) FlexPen®. FlexPen® is a discreet, prefilled insulin pen device that gives patients the ability to manage their diabetes while they’re on-the-go. FlexPen® is covered on more than 90 percent of insurance plans. For more information, visit www.levemir-us.com. About Levemir® (insulin detemir [rDNA origin] injection) Indications and Usage: Levemir® (insulin detemir [rDNA origin] injection) is a man-made long-acting insulin that is used to control high blood sugar in adults and children with diabetes mellitus. It is not recommended to use Levemir® to treat diabetic ketoacidosis. Important Safety Information: Do not take Levemir® if you are allergic to any of the ingredients in Levemir®. If you take too much Levemir®, your blood sugar may fall too low (hypoglycemia). Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them. Drinking alcohol may affect your blood sugar when you take Levemir®. Before you take Levemir®, tell your health care provider about all of the medicines you take, and all of your medical conditions, including if you have liver or kidney problems, or if you are pregnant or breastfeeding or if you are planning to do so. Do not make any changes to your dose or the type of insulin you use unless you are told to do so by your health care provider. Do not dilute or mix Levemir® with any other insulin or solution. Do not use Levemir® in an insulin pump. Inject Levemir® under your skin (subcutaneously) in your upper arm, abdomen (stomach area) or thigh. Never inject Levemir® into a vein or muscle. Do not share needles, insulin pens or syringes with others. Common side effects of Levemir® include low blood sugar (hypoglycemia), local allergic reactions at the injection site (redness, swelling and itching), and weight gain. Serious side effects include low blood sugar (hypoglycemia), skin thickening or pits at the injection site (lipodystrophy), and allergic reactions. Serious allergic reactions can cause life-threatening symptoms. Get medical help right away if you have any symptoms of an allergic reaction such as body rash, itching, shortness of breath or wheezing, fast heartbeat, sweating, or feel faint. Ask your health care provider or pharmacist for more information.