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RELiZORB (iMMOBILIZED lipase) cartridge

Causes and Consequences of Fat Malabsorption

Essential fatty acids are indispensable building blocks of human health1,2

The benefits of omega-3 fatty acids (DHA and EPA) start at the cellular level1,2

  • Fatty acids are derived from medium-chain and long-chain triglycerides (MCTs and LCTs)2,3
  • When hydrolyzed, LCTs yield omega-3 fatty acids, which benefit human health2
    • LCTs are the ONLY source of omega-3 fatty acids
  • DHA and EPA may have clinically important anti-inflammatory effects in a variety of conditions associated with fat malabsorption4,5

Omega-3 fatty acids support the development and function of multiple bodily systems2:

Omega-3 fatty acids support the development and function of multiple bodily systems
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Fats provide a higher concentration of calories than proteins and carbohydrates (9 cal/gram vs 4 cal/gram, respectively) and play a key role in growth and development.6–8

Fat malabsorption limits the benefits of enteral nutrition (EN) in patients with digestive disorders9–11

Short bowel syndrome (SBS)

Currently, patients with SBS may struggle with tolerating EN due to their limited digestive capabilities12,13

  • Symptoms of fat malabsorption can be severe and range from gastrointestinal issues to malnutrition and weight loss14,15
  • Fat malabsorption and lack of proper nutrients can adversely impact normal development and function1,8
  • Reducing patient dependence on parenteral nutrition (PN) relies on improving tube-feeding tolerance to reduce the number of PN-related complications, support intestinal adaptation, and improve patient outcomes16-18

Cystic fibrosis (CF)

Before participating in a multicenter, randomized, double-blind crossover trial with an open-label safety evaluation period, patients with CF and exocrine pancreatic insufficiency (EPI) had been receiving up to 1.5 L of enteral formula nightly for a mean of 6.6 years, yet still experienced8:

  • Low concentrations of omega-3 fatty acids
  • DHA and EPA plasma concentrations approximately 60% of the values observed in normal* subjects†
  • Below-target body mass index (BMI) despite use of accompanying pancreatic enzyme replacement therapy (PERT) capsules

Many pancreatic and GI conditions can lead to fat malabsorption9,11

Other conditions commonly associated with fat malabsorption5,19–22:

  • Acute/chronic pancreatitis
  • Trauma/critical care
  • Pancreatic and other GI cancers
  • Abdominal surgery
  • Inflammatory bowel disease

PERT capsules are not indicated for use with enteral formulas23-25

  • PERT capsules are indicated for oral use only and are not intended to be crushed or added to enteral-feeding formulas
  • Manufacturer’s prescribing information advise against crushing PERT products and adding them to formula
  • Crushing PERT capsules can result in overexposure of enzymes as well as clogged feeding tubes, and accidental inhalation of crushed PERT capsules can be a risk to both patients and caregivers
  • There are no prospective clinical trials, efficacy data, or safety data evaluating or supporting the use of PERT capsules with EN

RELiZORB hydrolyzes fats prior to ingestion and is the only FDA-cleared enzyme product that hydrolyzes fats in enteral formula.26,27

In enteral formulas, protein can be prepared in a form that is prehydrolyzed, stable, and available to be readily absorbed. However, prehydrolyzed fatty acids and monoglycerides are not available in enteral formulas since they are not stable and spoil quickly.28,29

RELiZORB is intended to provide continuous fat hydrolysis during tube feeding3,26

RELiZORB is intented to provide continuous fat hydrolysis during tube feeding

Frequent and consistent PERT dosing is needed for ongoing hydrolysis30

Frequent and consistent PERT dosing is needed for ongoing hydrolysis

‡Timing is based on volume and flow rate. A single RELiZORB cartridge can be used for up to 500 mL of formula at a rate of 10-400 mL/hr. A tandem RELiZORB cartridge configuration can be used for over 500 mL and up to 1000 mL of formula at a rate of 24-150 mL/hr.
Please see additional details in the Instructions for Use.26

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Traditional approaches to tube feeding could be improved to address the consequences of fat malabsorption in your patients with SBS, CF, and other conditions with digestive complications.16-18

See RELiZORB beyond the surface

About RELiZORB

DHA=docosahexaenoic acid; EPA=eicosapentaenoic acid.

*Consistent with reference range based on healthy subjects shown in the literature.8

†This study was funded by Alcresta Therapeutics, Inc. and conducted in patients with CF.8

References: 1. Omega-3 fatty acids: an essential contribution. Harvard T.H. Chan School of Public Health. Accessed November 28, 2023. https://www.hsph.harvard.edu/nutritionsource/what-should-you-eat/fats-and-cholesterol/types-of-fat/omega-3-fats/ 2. Omega-3 fatty acids: fact sheet for health professionals. National Institutes of Health: Office of Dietary Supplements. Updated July 18, 2022. Accessed November 28, 2023. https://ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/ 3. Shah ND, Limketkai BN. The use of medium-chain triglycerides in gastrointestinal disorders. Practical Gastroenterol. 2017;41(2):20-28. 4. Calder PC. Omega-3 fatty acids and inflammatory processes. Nutrients. 2010;2(3):355-374. doi:10.3390/nu2030355 5. National Institutes of Health. Malabsorption. Medline Plus. Updated May 6, 2022. Accessed November 28, 2023. https://medlineplus.gov/ency/article/000299.htm 6. Abedi E, Sahari MA. Long-chain polyunsaturated fatty acid sources and evaluation of their nutritional and functional properties. Food Sci Nutr. 2014;2(5):443-463. doi:10.1002/fsn3.121 7. Fat and calories. Cleveland Clinic. April 25, 2019. Accessed November 28, 2023. https://my.clevelandclinic.org/health/articles/4182-fat-and-calories 8. Freedman S, Orenstein D, Black P, et al. Increased fat absorption from enteral formula through an in-line digestive cartridge in patients with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2017;65(1):97-101. doi:10.1097/MPG.0000000000001617 9. Lindkvist B. Diagnosis and treatment of pancreatic exocrine insufficiency. World J Gastroenterol. 2013;19(42):7258-7266. doi:10.3748/wjg.v19.i42.7258 10. Rasmussen HH, Irtun O, Olesen SS, Drewes AM, Holst M. Nutrition in chronic pancreatitis. World J Gastroenterol. 2013;19(42):7267-7275. doi:10.3748/wjg.v19.i42.7267 11. Turck D, Braegger CP, Colombo C, et al. ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis. Clin Nutr. 2016;35(3):557-577. doi:10.1016/j.clnu.2016.03.004 12. Tsikis ST, Fligor SC, Hirsch TI, et al. A digestive cartridge reduces parenteral nutrition dependence and increases bowel growth in a piglet short bowel model.  Ann Surg. 2023;278(4):e876-e884. doi:10.1097/SLA.0000000000005839 13. Short bowel syndrome. National Institute of Diabetes and Digestive and Kidney Diseases. Updated April 2023. Accessed November 29, 2023. https://www.niddk.nih.gov/health-information/digestive-diseases/short-bowel-syndrome/all-content 14. Alkaade S, Vareedayah AA. A primer on exocrine pancreatic insufficiency, fat malabsorption, and fatty acid abnormalities. Am J Manag Care. 2017;23(suppl 12):S203-S209. 15. Blaauw R. Malabsorption: causes, consequences, diagnosis and treatment. S Afr J Clin Nutr. 2011;24(3):125-127. 16. Parrish CR, Copland AP. Enteral nutrition in the adult short bowel patient: a potential path to central line freedom. Practical Gastroenterol. 2021;45(4):36-51. 17. Parrish CR, DiBaise JK. Managing the adult patient with short bowel syndrome. Gastroenterol Hepatol (NY). 2017;13(10):600-608. 18. Stevens J, Wyatt C, Brown P, Patel D, Grujic D, Freedman SD. Absorption and safety with sustained use of RELiZORB evaluation (ASSURE) study in patients with cystic fibrosis receiving enteral feeding. J Pediatr Gastroenterol Nutr. 2018;67(4):527-532. doi:10.1097/MPG.0000000000002110 19. Capurso G, Traini M, Piciucchi M, Signoretti M, Arcidiacono PG. Exocrine pancreatic insufficiency: prevalence, diagnosis, and management. Clin Exp Gastroenterol. 2019;12:129-139. doi:10.2147/CEG.S168266 20. Singh VK, Haupt ME, Geller DE, Hall JA, Quintana Diez PM. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol. 2017;23(39):7059-7076. doi:10.3748/wjg.v23.i39.7059 21. Surmelioglu A, Ozkardesler E, Tilki M, Yekrek M. Exocrine pancreatic insufficiency in long-term follow-up after curative gastric resection with D2 lymphadenectomy: a cross-sectional study. Pancreatology. 2021;21(5):975-982. doi:10.1016/j.pan.2021.03.019 22. Blonk L, Wierdsma NJ, Jansma EP, Kazemier G, van der Peet DL, Straatman J. Exocrine pancreatic insufficiency after esophagectomy: a systematic review of literature. Dis Esophagus. 2021;34(12):1-6. doi:10.1093/dote/doab003 23. Schwarzenberg SJ, Hempstead SE, McDonald CM, et al. Enteral tube feeding for individuals with cystic fibrosis: Cystic Fibrosis Foundation evidence-informed guidelines. J Cyst Fibros. 2016;15(6):724-735. doi:10.1016/j.jcf.2016.08.004 24. Berry AJ. Pancreatic enzyme replacement therapy during pancreatic insufficiency. Nutr Clin Pract. 2014;29(3):312-321. doi:10.1177/0884533614527773 25. Nguyen DL. Guidance for supplemental enteral nutrition across patient populations.  Am J Manag Care. 2017;23(12):S210-S219. 26. RELiZORB. Instructions for use. Alcresta Therapeutics, Inc; 2023. 27. Alcresta Therapeutics announces FDA expanded use clearance for RELiZORB® (iMMOBILIZED LIPASE) Cartridge for pediatric patients ages 2 to 5 years. News release. Alcresta Therapeutics, Inc; August 31, 2023. 28. Limketkai BN, Shah ND, Sheikh GN, Allen K. Classifying enteral nutrition: tailored for clinical practice. Curr Gastroenterol Rep. 2019;21(9):47. doi:10.1007/s11894-019-0708-3 29. Mahesar SA, Sherazi STH, Khaskheli AR, Kandhro AA, Uddin S. Analytical approaches for free fatty acids assessment in oils and fats. Anal Methods. Published online May 15, 2014. doi:10.1039/C4AY00344F 30. Enzymes. Cystic Fibrosis Foundation. Accessed November 28, 2023. https://www.cff.org/managing-cf/enzymes

RELiZORB is indicated for use in pediatric patients (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula.

Warnings
  • RELiZORB is for use with enteral feeding only.
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RELiZORB is indicated for use in pediatric patients (ages 2 years 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.relizorbhcp.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.relizorbhcp.com/compatibility.
  • Do not use excessive force when using RELiZORB with enteral syringe push feeding methods.
  • Do not rush bolus feeds. Follow guidance from your healthcare professional on how long it should take you to complete your tube feeding.
  • Ensure all inlet and outlet connectors on RELiZORB and enteral feeding supplies are clean and dry prior to making connections.
  • In order to ensure product performance, store RELiZORB in its pouch either refrigerated or at room temperature (2°C to 27°C; 36°F to 80°F).
  • RELiZORB is indicated for use with enteral feeding only; patients should follow physician’s guidance for pancreatic enzyme replacement therapy (PERT) use for meals and snacks. Patients and patient caregivers should follow physician’s guidance regarding the need for pancreatic enzyme replacement therapy (PERT) during enteral feeding.

Review full product information for RELiZORB in the Instructions for Use.