adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
1.2 Limitation of Use
NESINA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
The recommended dose of NESINA is 25 mg once daily.
NESINA may be taken with or without food.
2.2 Patients with Renal Impairment
No dose adjustment of NESINA is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min).
The dose of NESINA is 12.5 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min).
The dose of NESINA is 6.25 mg once daily for patients with severe renal impairment (CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis). NESINA may be administered without regard to the timing of dialysis. NESINA has not been studied in patients undergoing peritoneal dialysis [see Clinical Pharmacology (12.3)].
Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of NESINA therapy and periodically thereafter.
3 DOSAGE FORMS AND STRENGTHS
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25 mg tablets are light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side.
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12.5 mg tablets are yellow, oval, biconvex, film-coated, with "TAK ALG-12.5" printed on one side.
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6.25 mg tablets are light pink, oval, biconvex, film-coated, with "TAK ALG-6.25" printed on one side.
4 CONTRAINDICATIONS
History of a serious hypersensitivity reaction to alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.
5 WARNINGS AND PRECAUTIONS
5.1 Pancreatitis
日本批准武田制药生产的DPP-4抑制剂Alogliptin与噻唑烷二酮类合用治疗2型糖尿病
NESINA® alogliptin benzoate Type 2 diabetes
日本武田制药有限公司（Takeda Pharmaceutical Company Limited）宣称，日本药监部门（Japanese Ministry of Health, Labour and Welfare）已批准其全资子公司武田圣地亚哥公司（Takeda San Diego,Inc.）生产的二肽基肽酶-4（dipeptidyl
peptidase-IV，DPP-4）抑制剂Alogliptin（商品名：Nesina）与噻唑烷二酮类（thiazolidinediones）合用治疗2型糖尿病（type 2 diabetes）。
Alogliptin高度选择性地显著抑制DPP-4，延缓胰高血糖素样肽-1（glucagon-like peptide-1，GLP-1）的灭活。GLP-1有助于改善胰岛β细胞功能，增加胰岛素分泌，而噻唑烷二酮类降糖药可减轻胰岛素抵抗。2型糖尿病2个最基本的病理变化就是胰岛素抵抗和胰岛素分泌减少及其分泌节律异常，上述两药合用可从不同环节改善血糖控制，有助于将血糖降至理想水平。
到目前为止，Alogliptin可用于下列血糖控制不好的2型糖尿病患者：单纯饮食和运动疗法治疗者，可单独使用Alogliptin；饮食和运动疗法及α-葡萄糖苷酶抑制剂（α-glucosidase inhibitor）或噻唑烷二酮类治疗者，可加用Alogliptin。Aloglitpin每天口服1次，每次25毫克。具体到每个患者，应遵医嘱。
Launches of “NESINA®” for treatment of type 2 diabetes, “UNISIA®” for treatment of hypertension
and “Vectibix®”, anti-cancer agent, in JapanOSAKA, Japan, June 15, 2010 --- Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it launched “NESINA®” (generic name: Alogliptin) for treatment of type 2 diabetes, “UNISIA®” (generic name: Candesartan Cilexetil / Amlodipine Besilate) for treatment of hypertension and “Vectibix®” (generic name: Panitumumab), anti-cancer agent.
NESINA is a dipeptidyl p
