近日，美国FDA已经批准Apidra用于控制成年糖尿病患者的血糖水平。APIDRA（Insulin glulisin）给患者带来灵活的餐时剂量胰岛素—可以在餐前或餐后15分钟给药。APIDRA还可以为各种体型的患者带来方便。
批准日期：2016年10月14日 公司：AVENTIS PHARM REFRIG
APIDRA（谷赖胰岛素[insulin glulisine]）注射液，用于皮下或静脉注射
美国最初批准：2004年
作用机制
葡萄糖代谢的调节是胰岛素和胰岛素类似物（包括谷赖胰岛素）的主要活性。胰岛素通过刺激骨骼肌和脂肪的外周葡萄糖摄取以及通过抑制肝葡萄糖产生来降低血糖。胰岛素抑制脂肪分解和蛋白水解，并增强蛋白质合成。
适应症和用法
APIDRA是一种速效人胰岛素类似物，用于改善成人和儿童糖尿病患者的血糖控制。
剂量和给药
有关重要的管理说明，请参阅完整的处方信息。
根据给药途径，个体代谢需求，血糖监测结果和血糖控制目标，个性化和调整APIDRA的剂量。
当从另一种胰岛素转换时，可能需要剂量调整，包括身体活动的变化，伴随药物的变化，膳食模式的变化，肾功能或肝功能的变化或急性疾病期间的变化。
皮下注射：
在饭前15分钟内或在开始进餐到腹部，大腿或上臂后20分钟内注射。
在同一区域内旋转注射部位。
通常应用于中效或长效胰岛素治疗方案。
连续皮下输注（胰岛素泵）:
通过腹壁连续皮下输注给药。
在同一区域内旋转输液部位。
不要在外部胰岛素泵中稀释或混合胰岛素。
静脉内给药：在0.9％氯化钠注射液USP使用聚氯乙烯输液袋稀释至0.05至1单位/mL APIDRA浓度后，仅在医疗监督下给药。
剂量形式和强度
APIDRA注射100单位/mL（U-100）可用作：
10mL多剂量小瓶
3mL单患者使用的SoloStar®预填充笔
禁忌症
在低血糖发作期间不要使用。
不要用于对APIDRA或其任何赋形剂过敏的患者。
警告和注意事项
切勿在患者之间共用APIDRA SoloStar笔，即使针更换了。
高血糖或低血糖与胰岛素治疗方案的变化：在密切的医疗监督下进行，并增加血糖监测的频率。
低血糖：可能危及生命。增加葡萄糖监测频率，改变：胰岛素剂量，共同降低葡萄糖的药物，膳食模式，身体活动;并且在肾功能不全或肝功能不全或低血糖的患者中无意识。
由于药物治疗错误导致的低血糖症：胰岛素产品之间可能发生意外混淆。指导患者在注射前检查胰岛素标签。
低钾血症：可能危及生命。监测有低钾血症风险的患者的钾水平，并进行治疗。
过敏反应和过敏反应：可能发生严重的，危及生命的全身性过敏，包括过敏反应。如果有指示，停止APIDRA，监测和治疗。
同时使用噻唑烷二酮类药物（TZDs）可发生液体潴留和心力衰竭：观察心力衰竭的体征和症状;如果发生心力衰竭，考虑减少剂量或停用TZD。
胰岛素泵装置故障引起的高血糖和酮症酸中毒：如果发生泵故障，监测葡萄糖并通过皮下注射给予APIDRA。
不良反应
通常与APIDRA相关的不良反应包括低血糖，过敏反应，注射部位反应，脂肪营养不良，瘙痒，皮疹和体重增加。
要报告疑似不良反应，请致电1-800-633-1610联系赛诺菲安万特或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
增加低血糖风险或增加或减少血糖降低效果的药物：可能需要调整剂量;密切监测血糖。
钝性低血糖症和症状的药物（例如，β-受体阻滞剂，可乐定，胍乙啶和利血平）：可能需要增加葡萄糖监测的频率。
包装提供/存储和处理
如何提供
APIDRA注射液，每毫升100单位（U-100），是一种透明无色的溶液，可用作：
10mL多剂量小瓶                                    NDC 0088-2500-33
3 mL单患者使用的APIDRA SoloStar预填充笔，5个包装  NDC 0088-2502-05
包装袋中不包括笔针。
SoloStar兼容Becton Dickinson and Company，Ypsomed和Owen Mumford的所有笔针。
APIDRA SoloStar预装笔轮以1个单位为增量。
存储
请勿在有效期后使用（参见纸箱和容器）。
未开封的Vial/SoloStar
未开封的APIDRA样品瓶和SoloStar应储存在36°F-46°F（2°C-8°C）的冰箱中。避光。 APIDRA不应存放在冰箱中，不应冻结。丢弃是否已冻结。
未开封的样品瓶/未储存在冰箱中的SoloStar必须在28天内使用。
打开（使用中）小瓶
打开的小瓶，无论是否冷藏，必须在28天内使用。如果无法冷藏，只要温度不高于77°F（25°C），使用中的开口小瓶可以保持不冷藏最多28天，远离直接热和光。
打开（使用中）SoloStar预填充笔
打开的（使用中）SoloStar不应冷藏，但应保持在77°F（25°C）以下，远离直接的热和光。保存在室温下的开口（使用中）SoloStar必须在28天后丢弃。
用于外部胰岛素泵
输液器（储液器，管道和导管）和储液罐中的APIDRA必须在使用48小时后或暴露于超过98.6°F（37°C）的温度后丢弃。
静脉使用
生理盐水溶液（0.9％氯化钠注射液，USP）的输液袋在室温下稳定48小时[见剂量和用法]。
完整说明资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e7af6a7a-8046-4fb4-9979-4ec4230b23aa
APIDRA(insulin glulisine injection), for subcutaneous or intravenous use
Indications and Usage for Apidra® (insulin glulisine injection)
Prescription Apidra is a fast (rapid) acting insulin used for adults and children with diabetes mellitus to control high blood sugar. It is not known if APIDRA is safe or effective in children less than 4 years of age with type 1 diabetes or in children with type 2 diabetes.
When used as a mealtime insulin, Apidra should be given within 15 minutes before or within 20 minutes after starting a meal.
Apidra may be infused subcutaneously by external insulin infusion pumps.
Important Safety Information for Apidra® (insulin glulisine injection)
Do not use Apidra if you have low blood sugar reaction or if you are allergic to insulin glulisine or any of the ingredients in Apidra.
Do not share needles, insulin pens or syringes with others even if the needle is changed. Do NOT reuse needles. You may give other people a serious infection, or get a serious infection from them.
Before starting Apidra, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breastfeeding or planning to breastfeed.
Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Apidra. Your treatment with TZDs and Apidra may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have new or worsening symptoms, including:
Shortness of breath
Sudden weight gain
Swelling of your ankles or feet
Tell your doctor about all medications you take, including OTC medicines, vitamins, supplements, and herbal supplements.
When used a mealtime insulin, Apidra should be taken within 15 minutes before a meal or within 20 minutes after starting a meal. Test your blood sugar levels as directed by your doctor when using Apidra. Do not change your dose or type of insulin without talking to your doctor. Any change of insulin should be made cautiously and only under medical supervision.
Check your insulin label to verify that you have the correct insulin before each injection. Use Apidra only if the solution is clear and colorless with no particles visible.
While using Apidra, do not drive or operate heavy machinery until you know how Apidra affects you. Do not drink alcohol or use medicines that contain alcohol.
Apidra may cause serious side effects that can lead to death, including:
Low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger.
Serious allergic reactions. Get medical help right away if you have: a rash over your whole body, shortness of breath, trouble breathing, fast pulse, sweating or feeling faint
Low potassium in your blood (hypokalemia). Your doctor should monitor you for low blood potassium levels.
Heart failure. Your doctor should monitor you closely while you are taking TZDs with Apidra.
Get emergency medical help if you have:
Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
The most common side effects of APIDRA include: low blood sugar (hypoglycemia), weight gain, itching, rash, swelling, allergic reactions including injection site reactions, skin thickening or pits at the injection site (lipodystrophy)
Important Safety Information for Apidra® (insulin glulisine injection) SoloStar
Apidra SoloSTAR is a disposable prefilled insulin pen. Please talk to your healthcare provider about proper injection techniques and follow instructions in the Instruction Leaflet that accompanies the pen.
Important Safety Information for Apidra® (insulin glulisine injection) when used in a pump
Replace the infusion sets (reservoir, tubing, and catheter), and the Apidra in the reservoir at least every 48 hours and select a new infusion site. Do not mix or dilute Apidra when used in the pump. Failure of your insulin pump or infusion set or degradation of the insulin in the pump can cause hyperglycemia and ketoacidosis. Always carry an alternate form of insulin administration in the case of pump failure.
Click here for Full Prescribing Information for Apidra®.
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The health information contained herein is provided for general education purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.
*Eligibility Restrictions
This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance program. Important to note that if you have an Affordable Care (Health Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note: the Federal Employees Health Benefits (FEHB) Program is not a federal or state government health care program for purposes of the savings program. This program is not valid where prohibited by law.
Offer Terms for Apidra $0 Co-pay Savings Card
For the duration of the program, the Savings Card offers a $0 copay with a maximum savings up to $600 per box for prescriptions covered by private or commercial insurance. This offer is valid for up to 3 boxes per prescription.
Offer Terms for Insulins Valyou Savings Program ($149/$99)
For the duration of the program, eligible patients will pay $149 for each pack of pens or $99 for each vial. Maximum quantity of ten packs of pens or ten vials per fill. Offer is valid for one fill per month. When using the Insulins Valyou Savings Card, prices are guaranteed for 12 consecutive monthly fills. This offer is not valid for the Max SoloStar pen. The Insulins Valyou Savings Program applies to the cost of medication. There are other relevant costs associated with overall treatment.
Savings may vary depending on patients’ out-of-pocket costs. Upon registration, patients receive all program details. Sanofi US reserves the right to change the maximum cap amount, rescind, revoke, or amend the program without notice.