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 爲腸外營養提供卡路里和必需脂肪酸
適應症的擴大表明 Baxter 持續致力於滿足從早產兒到成人的患者多樣化的營養需求
DEERFIELD, Ill. - 2024-05-13
伊利諾伊州迪爾菲爾德-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.
營養療法領域的全球領導者百特國際公司（紐約證券交易所代碼：BAX）今天宣佈，美國食品藥品管理局批准了Clinolipid（脂質注射乳液）的擴大適應症，用於兒科患者，包括早產兒和足月新生兒。Clinolipid 是 Baxter 專有的混合油脂質乳液，用於在無法進行口服或腸內營養、營養不足或禁忌時在腸外（靜脈注射）營養（PN）中提供卡路里和必需脂肪酸。自2019年以來，Clinolipid已在美國面向成人上市，現在可供所有年齡段的人使用。
"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
百特全球輸液療法與技術部總裁塞西莉亞·索里亞諾表示：“改善患者預後激勵着我們的日常工作，我們很自豪能夠繼續通過創新的產品和療法滿足新生兒和兒科患者的獨特營養需求。”“爲這些危重和脆弱的患者群體擴大獲得Clinolipid的機會，使臨床醫生能夠在最重要的時候選擇最能滿足患者需求的產品。”
具有獨特特性的混合脂質乳液
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:
腸外營養在幫助治療和降低營養不良風險方面起着重要作用。在美國，據估計，接受PN作爲靜脈注射營養來源的患者中，約有40％的年齡在18歲以下。[1]，[2] 靜脈注射脂質乳劑（ILEs）用於爲無法通過口服或腸內攝入足夠營養來源的患者提供卡路里和必需脂肪酸。在過去的幾年中，臨床實踐已從使用百分之百的大豆油脂質乳液（這是數十年的護理標準）轉向混合脂質乳液。在當今美國所有混合ILE中，百特的Clinolipid含有最少的大豆油（20％）和最高量的橄欖油（80％）。[3]，[4] 全球有超過1.5億劑疫苗，[5]Clinolipid已被證明是新生兒和兒科患者生長髮育所需的安全有效的能量和必需脂肪酸來源。[3] 具體而言，Clinolipid：
Clinolipid is available to order in the U.S. today. Click here to learn more about Baxter's clinical nutrition portfolio.
Clinolipid 今天可以在美國訂購。 點擊這裏 了解有關 Baxter 臨床營養產品組合的更多信息。
About Baxter's Global Clinical Nutrition Business
關於百特的全球臨床營養業務
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 廣泛的臨床營養產品組合包括代謝監測器、自動營養複合機和腸外營養解決方案。這些工具和解決方案有助於臨床醫生進行準確測量，與對照混合並有效滋養。我們創新且易於獲得的臨床營養產品和服務廣泛用於各種急性和替代性護理環境。
About Baxter
關於巴克斯特
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，數百萬患者、護理人員和醫療保健提供者依賴 Baxter 領先的診斷、重症監護、腎臟護理、營養、醫院和外科產品組合，這些產品廣泛應用於患者家庭、醫院、醫生辦公室和其他護理場所。90 多年來，我們一直在關鍵的十字路口開展業務，在這裏，拯救和維持生命的創新與實現這一目標的醫療保健提供者相遇。百特在全球100多個國家提供產品、數字健康解決方案和療法，他們現在正在公司豐富的醫學突破傳統基礎上再接再厲，推動下一代變革性的醫療保健創新。要了解更多信息，請訪問 www.baxter.com 然後關注我們 X/推特， 領英 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.
當無法進行口服或腸內營養、營養不足或禁忌時，應注射CLINOLIPID用於成人和兒科患者，包括足月和早產兒，作爲腸外營養（PN）的卡路里和必需脂肪酸的來源。
Important Risk Information
重要風險信息
- 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.
- 有以下情況的患者禁用CLINOLIPID注射劑：
-已知對雞蛋、大豆、花生或任何活性或非活性成分過敏。
-以高甘油三酯血癥爲特徵的嚴重脂質代謝障礙（血清甘油三酯>1,000 mg/dL）。 - 據報道，新生兒和嬰兒快速靜脈注射脂質乳劑會導致臨床失代償急性呼吸窘迫、代謝性酸中毒以及快速注射靜脈注射脂質乳劑後死亡。仔細監測嬰兒從血液循環中排出注入的脂質的能力（例如，測量血清甘油三酯和/或血漿遊離脂肪酸水平）。如果出現血液循環中脂質清除不良的跡象，請停止輸液並開始醫學評估。
- 腸外營養相關肝病（PNALD）：接受腸外營養超過2周的患者，尤其是早產兒的風險增加。監測肝臟檢查：如果出現異常，考慮停藥或減少劑量。
- 超敏反應：監測體徵或症狀。如果出現反應，請停止輸液。
- 感染風險、脂肪過載綜合症、再餵養綜合症、高甘油三酯血癥和必需脂肪酸缺乏症（EFAD）：監測體徵和症狀；監測實驗室參數。
-確保使用無菌技術進行導管放置、導管維護以及CLINOLIPID的製備和給藥。
-如果出現脂肪過載綜合徵的體徵或症狀，請停用 CLINOLIPID。
-爲預防再餵養綜合症引起的併發症，密切監測嚴重營養不良的患者，並慢慢增加他們的營養攝入量。
-在開始輸液之前測量血清甘油三酯，並在整個治療過程中定期測量。如果成人甘油三酯水平高於400 mg/dL，請停止CLINOLIPID輸注並監測血清甘油三酯水平，以避免高甘油三酯血癥的臨床後果。
-使用三烯與四烯比率的實驗室測試可能不足以診斷EFAD，可能需要評估個別脂肪酸水平。
- 鋁毒性：包括早產兒在內的腎功能損害患者的風險增加。CLINOLIPID 注射液中的鋁含量不超過 25 mcg/L。
- 成人臨床試驗中最常見（≥ 5%）的藥物不良反應是噁心和嘔吐、高脂血症、高血糖、低蛋白血癥和肝功能檢查異常。
- 兒科患者臨床試驗中最常見（≥ 5%）的不良反應是高膽紅素血癥、動脈導管狹窄、貧血、胃食管反流病、心動過緩、餵養不耐受、新生兒心室內出血、鹼性磷酸酶升高、心房隔缺損、低鈉血癥、敗血症和嬰兒呼吸暫停。
- 香豆素衍生物（包括華法林）的抗凝活性可能會被抵消。
Please see accompanying full Prescribing Information for CLINOLIPID.
請參閱隨附的完整處方信息 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.
本新聞稿包括有關Clinolipid潛在益處的前瞻性陳述。這些陳述基於對許多重要因素的假設，包括以下因素，這些因素可能導致實際結果與前瞻性陳述中的結果存在重大差異：對新產品和現有產品的需求和市場接受度；產品開發風險；無法及時創造額外的產能或出現其他製造或供應困難（包括自然災害、公共衛生危機和流行病、監管行動或其他原因）；滿意度監管和其他要求；監管機構和其他政府機構的行動；產品質量、製造或供應或患者安全問題；法律法規的變化；以及百特最近提交的10-K表和10-Q表格以及其他美國證券交易委員會文件中確定的其他風險，所有這些文件均可在百特網站上查閱。百特不承諾更新其前瞻性陳述。
Baxter and Clinolipid are registered trademarks of Baxter International Inc.
Baxter 和 Clinolipid 是 Baxter International Inc. 的註冊商標。
[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] 醫療保健質量與研究局。HCUP NIS 關於腸外營養使用情況的數據。2016 年。 https://hcupnet.ahrq.gov/#setup。2019 年 6 月 23 日訪問。
[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 等人腸外營養處方和訂單審查安全性研究：藥劑師干預的必要性。Nutr Clin Pract. 2021；36:480 —488。
[3] CLINOLIPID 20% (Lipid Injectable Emulsion) for intravenous use PI, 4/2024.
[3] 用於靜脈注射的 CLINOLIPID 20%（脂質可注射乳液）PI，4/2024。
[4] SMOFLIPID (lipid injectable emulsion), for intravenous use PI, 6/2023.
[4] SMOFLIPID（脂質注射乳液），用於靜脈注射 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。在兒童隊列研究中，人乳脂肪酸的組成與飲食、遺傳、社會人口和環境因素有關。Am J Clin Nutr. 2019；110 (6): 1370-1383。doi: 10.1093/ajcn/nqz229。
譯文內容由第三人軟體翻譯。