2014年9月18,美国食品药品监督管理局(FDA)已经批准礼来公司(Eli Lilly)研制的注射性药物度拉糖肽(度拉鲁肽,杜拉鲁肽,Dulaglutide, 商品名:Trulicity)用于2型糖尿病(T2D)的治疗。 批准日期:2014年9月18日;公司:Eli Lilly和公司 适应证和用途 TRULICITY™是一种胰高血糖素样肽(GLP-1)受体激动剂适用为辅助饮食和锻炼改善有2型糖尿病成年中血糖控制。 使用限制: ⑴ 不建议作为对饮食和锻炼控制欠佳患者一线治疗。 ⑵ 未曾在有胰腺炎病史患者中研究。考虑另外抗糖尿病治疗。 ⑶ 不是为1型糖尿病或糖尿病酮症酸中毒的治疗。 ⑷ 不是为有预先存在严重胃肠道疾病患者。 ⑸ 未曾研究与基础胰岛素联用。 剂量和给药方法 ⑴ 在给药天任何时间给予每周1次。 ⑵ 在腹部,大腿,或上臂皮下注射。 ⑶ 开始时0.75 mg皮下每周1次。为增加血糖控制剂量可被增加至1.5 mg每周1次。 ⑷ 如一剂被丢失在3天内给予丢失剂量. 剂型和规格 ⑴ 注射用:在单-剂量笔中0.75mg/0.5mL溶液 ⑵ 注射用:在单-剂量笔中1.5mg/0.5mL溶液 ⑶ 注射用:在单-剂量预装注射器中0.75mg/0.5mL溶液 ⑷ 注射用:在单-剂量预装注射器中1.5mg/0.5mL溶液 禁忌证 ⑴ 在有髓性甲状腺癌个人或家族病史患者或有多发性内分泌腺瘤综合征2型患者中不要使用。 ⑵ 如对TRULICITY或产品任何组分严重超敏性史不要使用。
Trulicity Generic Name and Formulations: Dulaglutide 0.75mg/0.5mL, 1.5mg/0.5mL; soln for SC inj; pen or prefilled syringe.
Company: Lilly, Eli and Company Indications for TRULICITY: Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Limitations Of use: Not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in combination with basal insulin or with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
Adult: Give by SC inj in the abdomen, thigh, or upper arm any time of the day, with or without food. ≥18yrs: initially 0.75mg once weekly; may increase to max 1.5mg once weekly if inadequate response. Renal impairment: caution with initiating or escalating doses.
Children: <18yrs: not established.
Pharmacological Class: Glucagon-like peptide-1 (GLP-1) receptor agonist.
Contraindications: History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Warnings/Precautions: Inform patients of thyroid cancer risk and symptoms. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of pancreatitis; consider other antidiabetic therapies. Discontinue if hypersensitivity occurs. Monitor renal function in renally-impaired patients reporting severe GI reactions. Hepatic impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions: Increased risk of hypoglycemia with concomitant sulfonylureas or insulin; consider reducing their doses. May affect absorption of other oral drugs (delayed gastric emptying).
Adverse Reactions: Nausea, diarrhea, vomiting, abdominal pain, decreased appetite, dyspepsia; acute pancreatitis.
Generic Availability: NO
How Supplied: Single-dose pen—4; Single-dose prefilled syringe—4 |