Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication
Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication
Clinolipid provides calories and essential fatty acids for parenteral nutrition
Expanded indication demonstrates Baxter's continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates to adults
Clinolipid 为肠外营养提供卡路里和必需脂肪酸
适应症的扩大表明 Baxter 持续致力于满足从早产儿到成人的患者多样化的营养需求
DEERFIELD, Ill. - 2024-05-13
伊利诺伊州迪尔菲尔德-2024-05-13
Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an expanded indication for Clinolipid (Lipid Injectable Emulsion) to be used in pediatric patients, including preterm and term neonates. Clinolipid is Baxter's proprietary mixed oil lipid emulsion that is used to provide calories and essential fatty acids in parenteral (intravenous) nutrition (PN) when oral or enteral nutrition is not possible, insufficient or contraindicated. Clinolipid has been available in the U.S. for adults since 2019 and is now available for use in all ages.
营养疗法领域的全球领导者百特国际公司（纽约证券交易所代码：BAX）今天宣布，美国食品药品管理局批准了Clinolipid（脂质注射乳液）的扩大适应症，用于儿科患者，包括早产儿和足月新生儿。Clinolipid 是 Baxter 专有的混合油脂质乳液，用于在无法进行口服或肠内营养、营养不足或禁忌时在肠外（静脉注射）营养（PN）中提供卡路里和必需脂肪酸。自2019年以来，Clinolipid已在美国面向成人上市，现在可供所有年龄段的人使用。
"Improving patient outcomes inspires our work every day, and we are proud to continue to address the unique nutritional needs of neonatal and pediatric patients through innovative products and therapies," said Cecilia Soriano, president of Baxter's global Infusion Therapies and Technologies division. "Expanding access to Clinolipid for this critical and vulnerable patient population offers clinicians versatility in choosing the product that best meets their patients' needs when it matters most."
A Mixed Lipid Emulsion with Unique Characteristics
百特全球输液疗法与技术部总裁塞西莉亚·索里亚诺表示：“改善患者预后激励着我们的日常工作，我们很自豪能够继续通过创新的产品和疗法满足新生儿和儿科患者的独特营养需求。”“为这些危重和脆弱的患者群体扩大获得Clinolipid的机会，使临床医生能够在最重要的时候选择最能满足患者需求的产品。”
具有独特特性的混合脂质乳液
Parenteral nutrition plays an important role in helping treat and reduce the risk of malnutrition. In the U.S., it's estimated that about 40 percent of patients who receive PN as an intravenous source of nourishment are under the age of 18.[1],[2] Intravenous lipid emulsions (ILEs) are used to provide calories and essential fatty acids for patients who cannot intake a sufficient source of nutrition orally or enterally. Over the last several years, clinical practice has shifted away from using 100 percent soybean oil lipid emulsions – which was the standard of care for decades – to mixed lipid emulsions. Baxter's Clinolipid contains the lowest amount of soybean oil (20 percent) and highest amount of olive oil (80 percent) of any mixed ILE available in the U.S. today.[3],[4] With more than 150 million doses worldwide,[5]Clinolipid has been shown to be a safe and effective source of energy and essential fatty acids needed for growth and development in neonatal and pediatric patients.[3] Specifically, Clinolipid:
肠外营养在帮助治疗和降低营养不良风险方面起着重要作用。在美国，据估计，接受PN作为静脉注射营养来源的患者中，约有40％的年龄在18岁以下。[1]，[2] 静脉注射脂质乳剂（ILEs）用于为无法通过口服或肠内摄入足够营养来源的患者提供卡路里和必需脂肪酸。在过去的几年中，临床实践已从使用百分之百的大豆油脂质乳液（这是数十年的护理标准）转向混合脂质乳液。在当今美国所有混合ILE中，百特的Clinolipid含有最少的大豆油（20％）和最高量的橄榄油（80％）。[3]，[4] 全球有超过1.5亿剂疫苗，[5]Clinolipid已被证明是新生儿和儿科患者生长发育所需的安全有效的能量和必需脂肪酸来源。[3] 具体而言，Clinolipid：
Clinolipid is available to order in the U.S. today. Click here to learn more about Baxter's clinical nutrition portfolio.
Clinolipid 今天可以在美国订购。 点击这里 了解有关 Baxter 临床营养产品组合的更多信息。
About Baxter's Global Clinical Nutrition Business
关于百特的全球临床营养业务
Baxter's broad portfolio of clinical nutrition products includes metabolic monitors, automated nutrition compounders and parenteral nutrition solutions. These tools and solutions help enable clinicians to measure accurately, mix with control and nourish effectively. Our innovative and accessible clinical nutrition products and services are used extensively across a wide array of acute and alternate care settings.
Baxter 广泛的临床营养产品组合包括代谢监测器、自动营养复合机和肠外营养解决方案。这些工具和解决方案有助于临床医生进行准确测量，与对照混合并有效滋养。我们创新且易于获得的临床营养产品和服务广泛用于各种急性和替代性护理环境。
About Baxter
关于巴克斯特
Every day, millions of patients, caregivers and healthcare providers rely on Baxter's leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X/Twitter, LinkedIn and Facebook.
每天，数百万患者、护理人员和医疗保健提供者依赖 Baxter 领先的诊断、重症监护、肾脏护理、营养、医院和外科产品组合，这些产品广泛应用于患者家庭、医院、医生办公室和其他护理场所。90 多年来，我们一直在关键的十字路口开展业务，在这里，拯救和维持生命的创新与实现这一目标的医疗保健提供者相遇。百特在全球100多个国家提供产品、数字健康解决方案和疗法，他们现在正在公司丰富的医学突破传统基础上再接再厉，推动下一代变革性的医疗保健创新。要了解更多信息，请访问 www.baxter.com 然后关注我们 X/推特， 领英 和 Facebook。
Indication
指示
CLINOLIPID injection is indicated in adults and pediatric patients, including term and preterm neonates as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
当无法进行口服或肠内营养、营养不足或禁忌时，应注射CLINOLIPID用于成人和儿科患者，包括足月和早产儿，作为肠外营养（PN）的卡路里和必需脂肪酸的来源。
Important Risk Information
重要风险信息
- The use of CLINOLIPID injection is contraindicated in patients with the following:
- Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients.
- Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL). -
Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. Carefully monitor the infant's ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation.
-
Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests: if abnormalities occur, consider discontinuation or dosage reduction.
-
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.
-
Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency (EFAD): Monitor for signs and symptoms; monitor laboratory parameters.
- Ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of CLINOLIPID.
- If signs or symptoms of fat overload syndrome occur, stop CLINOLIPID.
- To prevent complications from Refeeding Syndrome, closely monitor severely malnourished patients and slowly increase their nutrient intake.
- Measure serum triglycerides before the start of infusion and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the CLINOLIPID infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia.
- Laboratory testing using the triene to tetraene ratio may not be adequate to diagnose EFAD, and assessment of individual fatty acid levels may be needed.
-
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates. CLINOLIPID injection contains no more than 25 mcg/L of aluminum.
- Most common (≥5%) adverse drug reactions from clinical trials in adults were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia, and abnormal liver function tests.
- Most common (≥5%) adverse reactions from clinical trials in pediatric patients were hyperbilirubinemia, patent ductus arteriosus, anemia, gastroesophageal reflux disease, bradycardia, feeding intolerance, neonatal intraventricular hemorrhage, increased alkaline phosphatase, atrial septal defect, hyponatremia, sepsis, and infantile apnea.
- The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted.
- 有以下情况的患者禁用CLINOLIPID注射剂：
-已知对鸡蛋、大豆、花生或任何活性或非活性成分过敏。
-以高甘油三酯血症为特征的严重脂质代谢障碍（血清甘油三酯>1,000 mg/dL）。 - 据报道，新生儿和婴儿快速静脉注射脂质乳剂会导致临床失代偿急性呼吸窘迫、代谢性酸中毒以及快速注射静脉注射脂质乳剂后死亡。仔细监测婴儿从血液循环中排出注入的脂质的能力（例如，测量血清甘油三酯和/或血浆游离脂肪酸水平）。如果出现血液循环中脂质清除不良的迹象，请停止输液并开始医学评估。
- 肠外营养相关肝病（PNALD）：接受肠外营养超过2周的患者，尤其是早产儿的风险增加。监测肝脏检查：如果出现异常，考虑停药或减少剂量。
- 超敏反应：监测体征或症状。如果出现反应，请停止输液。
- 感染风险、脂肪过载综合症、再喂养综合症、高甘油三酯血症和必需脂肪酸缺乏症（EFAD）：监测体征和症状；监测实验室参数。
-确保使用无菌技术进行导管放置、导管维护以及CLINOLIPID的制备和给药。
-如果出现脂肪过载综合征的体征或症状，请停用 CLINOLIPID。
-为预防再喂养综合症引起的并发症，密切监测严重营养不良的患者，并慢慢增加他们的营养摄入量。
-在开始输液之前测量血清甘油三酯，并在整个治疗过程中定期测量。如果成人甘油三酯水平高于400 mg/dL，请停止CLINOLIPID输注并监测血清甘油三酯水平，以避免高甘油三酯血症的临床后果。
-使用三烯与四烯比率的实验室测试可能不足以诊断EFAD，可能需要评估个别脂肪酸水平。
- 铝毒性：包括早产儿在内的肾功能损害患者的风险增加。CLINOLIPID 注射液中的铝含量不超过 25 mcg/L。
- 成人临床试验中最常见（≥ 5%）的药物不良反应是恶心和呕吐、高脂血症、高血糖、低蛋白血症和肝功能检查异常。
- 儿科患者临床试验中最常见（≥ 5%）的不良反应是高胆红素血症、动脉导管狭窄、贫血、胃食管反流病、心动过缓、喂养不耐受、新生儿心室内出血、碱性磷酸酶升高、心房隔缺损、低钠血症、败血症和婴儿呼吸暂停。
- 香豆素衍生物（包括华法林）的抗凝活性可能会被抵消。
Please see accompanying full Prescribing Information for CLINOLIPID.
请参阅随附的完整处方信息 CLINOLIPID。
This release includes forward-looking statements concerning potential benefits associated with Clinolipid. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
本新闻稿包括有关Clinolipid潜在益处的前瞻性陈述。这些陈述基于对许多重要因素的假设，包括以下因素，这些因素可能导致实际结果与前瞻性陈述中的结果存在重大差异：对新产品和现有产品的需求和市场接受度；产品开发风险；无法及时创造额外的产能或出现其他制造或供应困难（包括自然灾害、公共卫生危机和流行病、监管行动或其他原因）；满意度监管和其他要求；监管机构和其他政府机构的行动；产品质量、制造或供应或患者安全问题；法律法规的变化；以及百特最近提交的10-K表和10-Q表格以及其他美国证券交易委员会文件中确定的其他风险，所有这些文件均可在百特网站上查阅。百特不承诺更新其前瞻性陈述。
Baxter and Clinolipid are registered trademarks of Baxter International Inc.
Baxter 和 Clinolipid 是 Baxter International Inc. 的注册商标。
[1] Agency for Healthcare Quality and Research. HCUP NIS data on parenteral nutrition use. 2016. https://hcupnet.ahrq.gov/#setup. Accessed June 23, 2019.
[1] 医疗保健质量与研究局。HCUP NIS 关于肠外营养使用情况的数据。2016 年。 https://hcupnet.ahrq.gov/#setup。2019 年 6 月 23 日访问。
[2] Kraft M et al. Parenteral Nutrition Prescribing and Order Review Safety Study: The Need for Pharmacist Intervention. Nutr Clin Pract. 2021;36:480–488.
[2] Kraft M 等人肠外营养处方和订单审查安全性研究：药剂师干预的必要性。Nutr Clin Pract. 2021；36:480 —488。
[3] CLINOLIPID 20% (Lipid Injectable Emulsion) for intravenous use PI, 4/2024.
[3] 用于静脉注射的 CLINOLIPID 20%（脂质可注射乳液）PI，4/2024。
[4] SMOFLIPID (lipid injectable emulsion), for intravenous use PI, 6/2023.
[4] SMOFLIPID（脂质注射乳液），用于静脉注射 PI，2023 年 6 月。
[6] Miliku K, Duan QL, Moraes TJ, et al. Human milk fatty acid composition is associated with dietary, genetic, sociodemographic, and environmental factors in the CHILD Cohort Study. Am J Clin Nutr. 2019;110(6):1370-1383. doi:10.1093/ajcn/nqz229.
[6] Miliku K、Duan QL、Moraes TJ 等。在儿童队列研究中，人乳脂肪酸的组成与饮食、遗传、社会人口和环境因素有关。Am J Clin Nutr. 2019；110 (6): 1370-1383。doi: 10.1093/ajcn/nqz229。
译文内容由第三方软件翻译。