2023年8月31日,Alcresta Therapeutics宣布，美国食品药品监督管理局（FDA）已批准将RELiZORB®的使用范围扩大到2至5岁以下的儿童。
RELiZORB是一种消化酶盒，旨在模拟胰脂肪酶的功能，该酶盒于2015年首次被美国食品药品监督管理局批准用于成年患者，并于2017年被批准用于5岁以下的儿童。RELiZORB是美国食品药品监督管理局批准用于肠内喂养的唯一酶产品。
2至<5岁的清除率是基于对2至<5岁患者的真实数据的回顾性评估，这些患者通过RELiZORB作为肠内喂养方案的一部分接受肠内配方奶粉。在该患者群体中使用RELiZORB没有发现其他安全问题。
关于RELiZORB®（iMMOBILIZE脂肪酶）墨盒
RELiZORB是一种首创的消化酶盒，旨在模拟胰脂肪酶的功能。RELiZORB是使用Alcresta专有的酶固定化技术iLipase®开发的，这是一种结合在小聚合物珠载体上的消化酶脂肪酶。
RELiZORB与肠内喂养系统串联连接。当肠内配方奶粉通过RELiZORB时，它会与iLipase接触，配方奶粉中的脂肪在摄入前被分解成可吸收的形式。
需要肠内营养的脂肪吸收不良患者不能有效地将营养中的脂肪水解（分解）成身体可以吸收的形式。脂肪吸收不良在因胰腺功能受损导致胰腺外分泌功能不全（EPI）而无法产生足够消化酶的个体中很常见。肠内配方奶粉不含预水解脂肪，因为它们不稳定，很快就会变质。肠内营养中脂肪的不完全水解会导致热量摄入减少和必需脂肪消化减少，这会显著影响生活质量和营养状况。儿童最容易受到未经治疗的胰腺功能不全的影响。
信息来源：
1）https://www.relizorb.com/how-relizorb-works/
2）https://www.prnewswire.com/news-releases/alcresta-therapeutics-announces-fda-expanded-use-
RELiZORB is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula.
Warnings
RELiZORB is for use with enteral feeding only.
RELiZORB should not be connected to any intravenous (IV) line, setup, or system.
Medications should not be administered through the RELiZORB cartridge. Do not add medications to the enteral formula or tubing before RELiZORB. The passage of medications through RELiZORB may adversely affect the medications or the ability of RELiZORB to hydrolyze fats.
Fibrosing Colonopathy - Fibrosing colonopathy is a rare, serious adverse reaction associated with high-dose use of pancreatic enzyme replacement therapy in the treatment of patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. RELiZORB contains lipase enzyme that is not from a porcine source. The lipase is bound to the beads, and this lipase-bead complex (iLipase) is retained within the RELiZORB cartridge. Continue to follow your physician’s guidance and porcine pancreatic enzyme labeling regarding porcine pancreatic enzyme use when used in conjunction with RELiZORB.
Cautions and Precautions
Do not re-use RELiZORB. RELiZORB is a single-use product. Re-use may result in contamination of the product. If re-used, RELiZORB may not effectively hydrolyze fats.
Do not break, alter, or place excess pressure on any part of RELiZORB. Any compromise of the structural integrity of RELiZORB may lead to improper connection to enteral feeding supplies, enteral formula leakage or risk of contamination.
Do not use RELiZORB after the date marked on the pouch.
Do not use blenderized formulas with RELiZORB. A detailed listing of enteral formulas compatible with RELiZORB can be found at www.relizorb.com/compatibility.
RELiZORB is designed for use with enteral feeding pump systems with low flow/no flow alarms and enteral syringes for manual bolus by syringe (push or gravity). A detailed listing of formulas, pumps, and enteral feeding supplies compatible with RELiZORB can be found at www.relizorb.com/compatibility.
Do not use excessive force when using RELiZORB with enteral syringe push feeding methods.
Do not rush bolus feeds. Follow guidance fr
