|
美国FDA批准Amylin Pharmaceuticals公司的醋酸普兰林肽预填充笔型注射剂(pramlintide acetate，SymlinPen 60/SymlinPen 120)上市，用于进餐时控制血糖。本品向患者提供了方便和准确剂量的用药器具。采用进餐胰岛素的糖尿病患者，添加醋酸普兰林肽可增强对血糖的控制。
SymlinPen 60的特点是每剂可释出15、30 、45或60 μg固定剂量的药物。SymlinPen 120的特点是每剂可释出60或120 μg固定剂量的药物。2种笔型注射器在首次使用后均可在不超过30 ℃的室温储藏。醋酸普兰林肽不可单独与基础胰岛素(非进餐胰岛素)联用。
醋酸普兰林肽是首个和迄今唯一用于糖尿病患者与进餐胰岛素联用的支链淀粉模拟物。
本品并不适用于所有糖尿病患者，当其与胰岛素联用时会增加胰岛素引起的严重低血糖，尤其是1型糖尿病患者常发生。醋酸普兰林肽注射后3小时内可出现药物引起的严重低血糖。应注意当驾车、操作重型机器或进行其它危险活动时出现严重低血糖会产生严重伤害。醋酸普兰林肽与胰岛素联用时最常见的其它不良反应是恶心等胃肠道不适。
INDICATIONS AND USAGE
SYMLIN is given at mealtimes and is indicated for:
•Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin.
•Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
CONTRAINDICATIONS
Hypersensitivity to SYMLIN or any of its components, including metacresol; confirmed diagnosis of gastroparesis; hypoglycemia unawareness.
WARNINGS
Patient Selection. Proper patient selection is critical to safe and effective use of SYMLIN. SYMLIN therapy should only be considered in patients with insulin-using type 2 or type 1 diabetes who fulfill the following criteria:
•have failed to achieve adequate glycemic control despite individualized insulin management;
•are receiving ongoing care under the guidance of a healthcare professional skilled in the use of insulin and supported by the services of diabetes educator(s).
Patients meeting any of the following criteria should NOT be considered for SYMLIN therapy:
•poor compliance with current insulin regimen;
•poor compliance with prescribed self-blood glucose monitoring;
•have an HbA1c >9%;
•recurrent severe hypoglycemia requiring assistance during the past 6 months;
•presence of hypoglycemia unawareness;
•confirmed diagnosis of gastroparesis;
•require the use of drugs that stimulate gastrointestinal motility;
•pediatric patients.
Hypoglycemia. SYMLIN alone does not cause hypoglycemia. However, SYMLIN is indicated to be co-administered with insulin therapy and in this setting SYMLIN increases the risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. Therefore, when introducing SYMLIN therapy, appropriate precautions need to be taken to avoid increasing the risk for insulin-induced severe hypoglycemia. These precautions include frequent pre- and post-meal glucose monitoring combined with an initial 50% reduction in pre-meal doses of short-acting insulin.
ADVERSE EVENTS
The most common adverse event was nausea, which decreased with time in most patients. For adverse events regarding severe hypoglycemia, see WARNINGS.
PRINCIPAL DISPLAY PANEL - 5 mL Vial Label
NDC 66780-110-01
Rx Only
Symlin®
(pramlintide acetate) injection
0.6 mg/mL
5 mL Vial
SUBCUTANEOUS USE ONLY
AMYLIN Pharmaceuticals, Inc.
San Diego, CA 92121 USA
PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
Subcutaneous Use Only
Rx Only
NDC 66780-110-01
Symlin®
(pramlintide acetate) injection
0.6 mg/mL
5 mL Vial
PRINCIPAL DISPLAY PANEL - 1.5 mL Cartridge Label
LOT/EXP
911002-02
NDC 66780-115-02
SymlinPen® 60
(pramlintide acetate)
pen-injector
For doses of 15 mcg, 30 mcg,
45 mcg, and 60 mcg.
1000 mcg/mL, 1.5 mL
Rx Only
Amylin Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL - 1.5 mL Cartridge Carton
SymlinPen® 60
(pramlintide acetate)
pen-injector
For doses of 15 mcg, 30 mcg,
45 mcg, and 60 mcg.
Two disposable multidose
pen-injectors pramlintide acetate
1000 mcg/mL, 1.5 mL
NDC 66780-115-02
Rx Only
Two 1.5 mL disposable multidose pen-injectors
15•30•45•60 mcg
Subcutaneous use only. Pen needles not included. Use 29, 30, or 31
gauge disposable pen needles. Ask your healthcare provider which
needle gauge and length is best for you.
AMYLIN®
PRINCIPAL DISPLAY PANEL - 2.7 mL Cartridge Label
LOT/EXP
911004-03
NDC 66780-121-02
SymlinPen® 120
(pramlintide acetate)
pen-injector
For doses of 60 mcg and 120 mcg.
1000 mcg/mL, 2.7 mL
Rx Only
Amylin Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL - 2.7 mL Cartridge Carton
SymlinPen® 120
(pramlintide acetate)
pen-injector
For doses of 60 mcg and 120 mcg.
Two disposable multidose
pen-injectors pramlintide acetate
1000 mcg/mL, 2.7 mL
NDC 66780-121-02
Rx Only
Two 2.7 mL disposable multidose pen-injectors
60•120 mcg
Subcutaneous use only. Pen needles not included. Use 29, 30, or 31
gauge disposable pen needles. Ask your healthcare provider which
needle gauge and length is best for you. | 
