Exenatide Injection
2011-04-11    彰基藥學部藥品管理組   
列印自: 新藥介紹
網址: http://pharm.cch.org.tw/newdrug/article.php?articleid=362
Byetta

Supply: 0.25mg/ml;1.2ml/pen (300 mcg/ 60dose /1.2ml)                      <<MIEXEC>>

          0.25mg/ml;2.4ml/pen (600 mcg/ 60dose /2.4ml)                      <<MIEXEH>>

Description: Byetta is a biosynthetic version of a salivary peptide from a Gila monster, 53% homology to human GLP-1, bind to the GLP-1 receptor for treatment of type 2 diabetic melliitus in combination with metformin, and/or SU in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Action : Exenatide is an analog of the hormone incretin (GLP-1) which mimics the enhancement of glucose-dependent insulin secretion and exhibit other antihyperglycemic actions following release into circulation from the gut. Exenatide may decrease HbA1C by 0.5- 1%.

Pharmacokinetics: Bioavailability: 65-76%; half-life:2.4 hrs; Tmax: 2.1 hrs; renal elimination: 73%; clearance: 9.1 L/hr.

Indication: 第二型糖尿病

健保規範:

1.限用於已接受過最大耐受劑量的metformin/sulfonylurea類藥物仍 無法理想控制血糖之第二型糖尿病患者。

2.本藥品不得與insulinDPP-4抑制劑(如sitagliptin成分)等藥物併用。

院內規範:

1. 第二型糖尿病患者,若已經使用適當劑量的metformin或一種以上的口服降血糖藥物(包括metformin, sulfonylurea, TZD),而仍然無法達到良好的血糖控制者(HbA1C≥7.5%),且符合下列條件之一者,得開始使用Exenatide

(1) 無其他代謝疾病之中度肥胖者 (BMI > 30 kg/m2)

(2) 輕度肥胖 (27 kg/m2 < BMI≤30 kg/m2) 合併有其他心血管疾病者,或經臨床醫師判定不適用胰島素者

2. 下列情況不適用Exenatide

(1) 第一型糖尿病患者

(2) 尚未使用任何口服降血糖藥物的第二型糖尿病患者

(3) 嚴重腎功能不全(creatinine clearance <30 ml/min ) 患者

(4) 具罹患胰臟炎高風險者

3. 限內分泌新陳代謝科、減重中心醫師使用。

Dosage and Administration: before meal, SC

  Initial 5 mcg bid for the first 4 wks,

 Maintenance 10 mcg bid after 1 month of therapy.

Dosage in Renal impairment

   CrCl 50 - 80 mL/min: dose adjustment not necessary.

   CrCl 30 - 50 mL/min: use caution when initiating or increasing a dose from 5 ~10 mcg.

   ESRD receiving dialysis or CrCl30 mL/min: not recommended.

Adverse drug reaction:

More frequent: Hypoglycemia (4.5-35.7%); diarrhea (13%); nausea(44%); indigestion (6%); vomiting (13%); antibody development (6%-9% ); dizziness (9%); feeling nervous (9%); headache (9%).

Rare: Acute hemorrhagic pancreatitis; acute necrotizing pancreatitis; acute pancreatitis; dehydration ; anaphylaxis; hypersensitivity reaction; acute renal failure; angioedema.

Contraindication: Contraindicated use in patient with severe hypersensitivity to exenatide or any product component.

CautionCaution use in patient with type 1 diabetes, diabetic ketoacidosis, renal impairment, ESRD, acute pancreatitis, gastrointestinal disease, hypovolemia, hypersensitivity reactions, dehydration.

Storage & Stability: 2- 8°C

Note:

1.       給藥時間,可於餐前60分鐘內之任何時間注射。

2.       可注射於大腿腹部或上臂。

3.       須冷藏保存,於< 25、避光環境下,最多只可儲存30天。

4.       開封30天後,即不建議再使用。

Pregnancy Category: C

Breastfeeding: Infant risk cannot be ruled out.

Reference:

1. USP DI 27th 2007. 

2. MICROMEDEX(R) Healthcare Series Vol. 147 expires 2010.   

3. Drug package Insert.

責任編輯: racer