| 近日，FDA批准糖尿病复方新药Invokamet XR（canagliflozin/缓释二甲双胍），结合饮食和运动，用于2型糖尿病成人患者的一线治疗。Invokamet XR是由固定剂量的canagliflozin和缓释配方的二甲双胍组成的糖尿病复方药；canagliflozin（品牌名Invokana）是美国市场获批的首个也是处方量最大的选择性钠葡萄糖协同转运蛋白2（SGLT2）抑制剂，自上市以来处方量已超过900万。二甲双胍则是用于2型糖尿病早期治疗时最常用的一种药物。 批准日期：2016年9月23日 公司：杨森制药公司 INVOKAMET XR（卡格列净和盐酸二甲双胍 [canagliflozin/metformin hydrochloride]）缓释片剂，供口服使用 最初美国批准 - 2016年 警告： 乳酸ACIDOSISSee完整处方完整黑框警告信息。 二甲双胍相关乳酸性酸中毒的上市后的情况下导致死亡，低体温，低血压和耐缓慢性心律失常。症状包括全身不适，肌肉疼痛，呼吸困难，嗜睡和腹痛。实验室检查异常包括升高血乳酸水平，阴离子间隙酸中毒，加重乳酸/丙酮酸比值;和二甲双胍血浆水平一般>5微克/毫升。 风险因素包括肾功能损害，同时使用某些药物，年龄>65岁以上，与此相反，手术等程序，缺氧状态，过量饮酒和肝功能损害放射性研究。以减少风险和完整的处方信息中提供了这些高危人群管理二甲双胍相关的乳酸性酸中毒。 如果乳酸性酸中毒怀疑，停止INVOKAMET XR和在医院实行一般支持措施。建议提示血液透析。 作用机理 INVOKAMET XR INVOKAMET XR（卡格列净和二甲双胍盐酸盐）结合作用的补充机制两种口服抗高血糖剂以改善血糖控制的患者的2型糖尿病：卡格列净，钠-葡萄糖共转运2（SGLT2）抑制剂和二甲双胍盐酸盐，构件的双胍类。 卡格列净 钠-葡萄糖共转运2（SGLT2），在近端肾小管中表达，是负责多数过滤葡萄糖从管状内腔再吸收的。卡格列净是SGLT2的抑制剂。通过抑制SGLT2，卡格列净减少过滤葡萄糖的再吸收和降低了的葡萄糖肾阈值（RTG），并且由此增加尿葡萄糖排泄（UGE）。 二甲双胍 二甲双胍是提高患者的2型糖尿病患者的葡萄糖耐受性，降低基础和餐后血浆葡萄糖的抗高血糖剂。二甲双胍降低肝葡萄糖生产，降低葡萄糖的肠吸收，并通过增加外周葡萄糖摄取和利用提高胰岛素的敏感性。二甲双胍不产生在任何例2型糖尿病或正常的患者发生低血糖除特殊情况外[见警告和注意事项]，不会引起高胰岛素血症。与二甲双胍治疗，胰岛素的分泌，同时保持空腹胰岛素水平和一天的血浆胰岛素反应可能实际上会降低不变。 适应症和用法 INVOKAMET XR是钠 - 葡萄糖协同转运2（SGLT2）抑制剂和双胍组合产品表示作为辅助饮食和锻炼，以改善血糖控制成人2型糖尿病时既卡格列净和二甲双胍治疗是适当的。 使用限制： 不治疗1型糖尿病或糖尿病酮症酸中毒。 用法用量 根据病人的当前方案个性。 吃两片，每天一次的早上吃饭。 在目前未与任何卡格列净或二甲双胍治疗的患者，开始有两个INVOKAMET XR片剂，含卡格列净50毫克和500二甲双胍毫克每片治疗。 在已经与卡格列净和二甲双胍治疗的患者，切换到包含卡格列净的相同的总日剂量和相同的，或二甲双胍最近的适当，日总剂量2 INVOKAMET XR片剂。 在需要额外的血糖控制所服用的卡格列净100毫克的总日剂量的患者，INVOKAMET XR剂量可增至每天一次卡格列净300毫克。不超过300毫克的总日卡格列净剂量。 逐渐升级二甲双胍的剂量，以减少胃肠道副作用同时不超过2000毫克每日总剂量 发起并在此后定期评估前肾功能。 INVOKAMET XR是禁忌在病人低于45毫升/分的估计肾小球滤过率（eGFR）/ 1.73m平方米 限制卡格列净成分的剂量，以两片，含有50毫克，每天患者45的EGFR至小于60毫升/分钟/1.73mm 2各自片剂。 INVOKAMET XR可能需要，或之前，含碘造影成像过程的时间来停止。 燕子的整体。不要挤压，切割，或咀嚼。 剂型和规格 薄膜包衣片剂： 卡格列净50毫克的盐酸二甲双胍500毫克缓释 卡格列净50毫克的盐酸二甲双胍1000毫克缓释 卡格列净150 mg和盐酸二甲双胍500毫克缓释 卡格列净150 mg和盐酸二甲双胍1000毫克缓释。 禁忌症 中度至重度肾功能受损（EGFR低于45毫升/分钟/ 1.73m平方米），晚期肾病或透析。 代谢性酸中毒，包括糖尿病酮症酸中毒。 严重过敏反应的历史记录卡格列净或二甲双胍。 警告和注意事项 乳酸性酸中毒：见黑框警告。 低血压：启动INVOKAMET XR之前，评估肾损害患者，老年人，患者低收缩压，或利尿剂，ACEI，ARB或卷的状态和正确的血容量不足。监测治疗期间症状和体征。 酮症酸中毒：评估与标志和用于酮症酸中毒代谢性酸中毒的症状呈现谁的患者，不论血糖值。如果怀疑，停止INVOKAMET XR，评估并及时治疗。启动INVOKAMET XR之前，考虑酮症酸中毒的危险因素。在INVOKAMET XR患者可能需要在已知诱发酮症酸中毒临床情况的监测和治疗停药临时。 急性肾损伤和损害肾功能：考虑暂时停止在减少误服或流体损失的设置。如果出现急性肾损伤，停止并及时治疗。监测治疗期间肾功能。 高钾血症：监测患者的肾功能受损，并易患高钾血症患者血钾水平。 尿脓毒症和肾盂肾炎：评估患者症状和泌尿道感染的症状和及时治疗，如果指示。 低血糖：考虑胰岛素或胰岛素促分泌素的较低剂量与INVOKAMET XR组合使用时降低低血糖的风险。 生殖器真菌感染：监控并表示若治疗。 过敏反应：请停止INVOKAMET XR和监控，直到症状和体征的决心。 骨折：考虑有助于启动INVOKAMET XR之前骨折的危险因素。 维生素B12缺乏：二甲双胍可降低维生素B12水平。每年监测血液学参数。 增加LDL-C：监视LDL-C并在适当对待。 不良反应 女性生殖器真菌感染，尿路感染，排尿增加：与卡格列净（5％或更高的发病率）有关的最常见的不良反应。 与二甲双胍（5％或更高的发病率）有关的最常见的不良反应为腹泻，恶心，呕吐，腹胀，乏力，消化不良，腹部不适和头痛。 药物相互作用 碳酸酐酶抑制剂可提高乳酸性酸中毒的危险。考虑更频繁的监测。 由肾小管分泌（例如阳离子药物如西咪替丁）消除的药物，可能会增加二甲双胍的积累。考虑更频繁的监测。 酒精可以使可能二甲双胍对乳酸代谢的影响。警惕过量饮酒的患者。 UGT诱导剂（例如，利福平）：卡格列净曝光被降低。考虑每天一次从一个总日剂量为100毫克增加卡格列净到每日总剂量为300毫克。 地高辛：地高辛监测水平。 特殊人群中使用 妊娠：特别是在第二和第三个三个月劝的潜在风险到胎儿的女性。 哺乳期：哺乳时，不推荐INVOKAMET XR。 女性与生殖潜力男性：建议潜在的绝经前女性的意外pregnanc。 老年医学：与减少血容量不良反应的发生率较高。更频繁地评估肾功能。 肾损害：与减少血容量，肾功能不良反应的发生率较高。 肝损伤：避免在肝损伤患者使用。 包装规格 INVOKAMET XR TAB 50/500MG 60 canagliflozin/metformin hydrochloride extended-release NDC 50458-940-01 INVOKAMET XR TAB 50/1000MG 60 canagliflozin/metformin hydrochloride extended-release NDC 50458-941-01 INVOKAMET XR TAB 150/500MG 60 canagliflozin/metformin hydrochloride extended-release NDC 50458-942-01 INVOKAMET XR TAB 150/1000MG 60 canagliflozin/metformin hydrochloride extended-release NDC 50458-943-01 ------------------------------------------------------- Janssen Submits INVOKAMET® XR(Canagliflozin/Metformin Hydrochloride Extended Release) for Approval by the U.S. FDA as an Adjunctive Treatment in Adults with Type 2 Diabetes Invokamet® XR Extended-release canagliflozin/metformin approved Invokamet XR is available in four dosages, in tablets containing canagliflozin 50 milligrams (mg) or 150 mg, and metformin XR 500 mg or 1000 mg. The recommended dosing is two tablets once daily with the morning meal. IMPORTANT SAFETY INFORMATION INVOKAMET® can cause serious side effects, including: •Lactic Acidosis. Metformin, one of the medicines in INVOKAMET®, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking INVOKAMET® and call your doctor right away if you have any of the following symptoms which could be signs of lactic acidosis: feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have unusual sleepiness or sleep longer than usual; have stomach pains, nausea, or vomiting; feel dizzy or lightheaded; or have a slow/irregular heartbeat You have a higher chance of getting lactic acidosis with INVOKAMET® if you have conditions such as: kidney problems, or your kidneys are affected by certain X-ray tests that use injectable dye; liver problems; congestive heart failure; drink alcohol very often, (or drink a lot of alcohol in short-term); get dehydrated; have surgery; have a heart attack, severe infection, or stroke; or are 80 years of age or older and have not had your kidneys tested. Do not take INVOKAMET® if you: •Have severe kidney problems or are on dialysis, have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine). Are allergic to canagliflozin, metformin, or any of the ingredients in INVOKAMET®. See the end of the Medication Guide for a list of ingredients in INVOKAMET®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing Before you take INVOKAMET®, tell your doctor if you: have kidney problems, have liver problems, are on a low sodium (salt) diet, have ever had an allergic reaction to INVOKAMET®, or are going to get an injection of dye or contrast agents for an X-ray procedure (INVOKAMET® will need to be stopped for a short time); have heart problems (including congestive heart failure); drink alcohol very often (or drink a lot of alcohol in short-term); or have any other medical conditions. Tell your doctor if you are or plan to become pregnant, are breastfeeding or plan to breastfeed. It is not known if INVOKAMET® will harm your unborn baby. It is also not known if INVOKAMET® passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® - used to treat HIV infection), or digoxin (Lanoxin® - used to treat heart problems). Possible Side Effects of INVOKAMET® INVOKAMET® may cause serious side effects, including: dehydration- INVOKAMET® can cause some people to have dehydration (the loss of body water and salt), kidney problems, a high amount of potassium in your blood (hyperkalemia), liver problems, or low blood sugar (hypoglycemia). If you take INVOKAMET® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKAMET®. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery. Vaginal yeast infection: Women taking INVOKAMET® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish discharge, or vaginal itching. Yeast infection of the penis (balanitis or balanoposthitis): Men taking INVOKAMET® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash; foul smelling discharge; or pain in the skin around penis. Serious allergic reaction: If you have any symptoms of a serious allergic reaction, stop taking INVOKAMET® and call your doctor right away or go to the nearest hospital emergency room. Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture. Low vitamin B12 (vitamin B12 deficiency): Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood. Your doctor may do blood tests to check your levels. The most common side effects of INVOKAMET® include: urinary tract infection; changes in urination, including urgent need to urinate more often, in larger amounts, or at night; diarrhea, nausea and vomiting, gas, weakness, indigestion, upset stomach, or headache. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. Please see the full Product Information, including Boxed Warning, and Medication Guide. WHAT IS INVOKANA®? INVOKANA® is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age. IMPORTANT SAFETY INFORMATION INVOKANA® can cause important side effects, including: •Dehydration (the loss of body water and salt), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older •Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching •Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling of the penis; rash of the penis; foul-smelling discharge from the penis; or pain in the skin around penis Talk to your doctor about what to do if you get symptoms of a yeast infection of the vagina or penis. Do not take INVOKANA® if you: •are allergic to canagliflozin or any of the ingredients in INVOKANA®. Symptoms of allergic reaction may include: rash; raised red patches on your skin (hives); or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing •have severe kidney problems or are on dialysis Before you take INVOKANA®, tell your doctor if you have kidney problems, liver problems, are on a low sodium (salt) diet, ever had an allergic reaction to INVOKANA®, or have other medical conditions. Tell your doctor if you are or plan to become pregnant, are breastfeeding, or plan to breastfeed. It is not known if INVOKANA® will harm your unborn baby. It is also not known if INVOKANA® passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take diuretics (water pills), rifampin (used to treat or prevent tuberculosis), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir®, Kaletra® - used to treat HIV infection), or digoxin (Lanoxin® - used to treat heart problems). Possible Side Effects of INVOKANA® INVOKANA® may cause serious side effects, including: kidney problems, a high amount of potassium in your blood (hyperkalemia), or low blood sugar (hypoglycemia). If you take INVOKANA® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA®. Signs and symptoms of low blood sugar may include: headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking, or feeling jittery. Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA® and call your doctor right away or go to the nearest hospital emergency room. Broken Bones (fractures): Bone fractures have been seen in patients taking INVOKANA®. Talk to your doctor about factors that may increase your risk of bone fracture. The most common side effects of INVOKANA® include: vaginal yeast infections and yeast infections of the penis; urinary tract infection; or changes in urination, including urgent need to urinate more often, in larger amounts, or at night. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. 完整处方资料来源：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9da7283e-9168-45df-9749-dc51cfcca450 |
INVOKAMET XR TAB（卡格列净和盐酸二甲双胍缓释片）简介：近日，FDA批准糖尿病复方新药Invokamet XR（canagliflozin/缓释二甲双胍），结合饮食和运动，用于2型糖尿病成人患者的一线治疗。Invokamet XR是由固定剂量的canagliflozin和缓释配方的二甲双胍组成的糖尿 ... 责任编辑：admin |
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