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Discover updates to RELiZORB and what they mean for your patients #

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RELiZORB (iMMOBILIZED lipase) cartridge

Proven to Hydrolyze Fats and Improve Fat Absorption1

Proven to normalize* absorption of fatty acids with sustained and immediate use1,2

Clinical data in exocrine pancreatic insufficiency (EPI)

Immediate use of RELiZORB normalizes* absorption of fatty acids in cystic fibrosis (CF)1,2

Study 497†: A double-blind, placebo-controlled crossover treatment period with a follow-up safety period was used to evaluate safety, tolerability, and fat absorption with RELiZORB in patients with EPI due to CF.1,2

View study design

Changes in plasma concentrations of DHA and EPA1,3

DHA and EPA were used as measures in the studies as they are strongly correlated with overall fat absorption

DHA and EPA were used as measures in the studies as they are strongly correlated with overall fat absorption.

2.8-fold overall increase in total DHA and EPA vs placebo (AUC0-24h; P<0.001)2

Gastrointestinal (GI) Events1

GI events are expressed as: number of events (number of patients reporting events)

GI events are expressed as: number of events (number of patients reporting events).

57% reduction in the incidence of diarrhea from Period A to Period C2,†

  • Overall, the frequency of GI events decreased in Period C compared with Period A among 33 pediatric and adult patients with CF2,†
  • During Period C of the trial, 42% (n=14) of patients using RELiZORB stopped taking pancreatic enzyme replacement therapy (PERT) capsules despite protocol instructions to maintain their usual treatment practice2,†

Sustained use of RELiZORB normalizes* absorption of fatty acids in CF4

498 ASSURE Study: A 90-day, multicenter, open-label study, in which RELiZORB was used with overnight tube feeding, that evaluated the safety, tolerability, and improvement in fatty acid status in red blood cell (RBC) membranes in patients with EPI due to CF.4

View study design

Changes in Erythrocyte Membrane Fatty Acid Composition (%) for Omega-3 Index4

  • Statistically significant increases observed at Days 30, 60, and 90 (P<0.001 for each)
Statistically significant increases observed at Days 30, 60, and 90

2.1-fold increase in RBC uptake of DHA and EPA relative to total fatty acid and erythrocyte membranes1,4

Sustained use of RELiZORB in 498 STUDY4

  • No reported incidences of diarrhea at Day 90
  • Overall, the number of participants reporting GI symptoms decreased from Day 30 to 90
  • No participants discontinued RELiZORB due to an adverse event 

61% of participants demonstrated improvement in weight percentiles4,§

All exploratory efficacy outcomes, including serum levels of fat-soluble vitamins A, D, and E in plasma total protein, prealbumin, albumin, and transferrin, were within normal ranges at study entry and remained so throughout the 90-day study treatment period.4

*Use of RELiZORB was shown to normalize concentrations to levels consistent with a reference range based on healthy subjects as shown in the literature.2,4

†Study 497 consisted of 3 distinct periods. Period A lasted 7 days and was meant to establish a baseline while patients maintained their standard PERT dosing along with overnight tube feeding. Period B lasted 11 days (including a 7-day washout period before crossover) and evaluated the effect of RELiZORB use on fat absorption via DHA and EPA plasma measures. Period C lasted 7 days and evaluated the safety and tolerability of RELiZORB by comparing outcomes with Period A (baseline).1,2

‡P<0.001 for difference from baseline to Day 30, Day 60, and Day 90.4

§Overall, weight and BMI z-scores and percentiles were not significantly different from baseline to 90 days. However, 20/33 (61%) patients had improvement in weight z-scores and percentiles in the intention-to-treat (ITT) population.4

RELiZORB PRECLINICAL DATA IN EPI AND SBS PORCINE MODELS

In preclinical porcine models of EPI

Single-Feed Study1,||

Evaluated tolerability and fat absorption with use of RELiZORB during a single tube feeding. 

Multi-Feed Study1,¶

Evaluated tolerability and fat absorption with use of RELiZORB following 12 consecutive nightly tube feedings.

DHA & EPA plasma concentrations following use of RELiZORB during a single TUBE feeding1,||

RELiZORB demonstrated an increase in fat absorption, an increase in plasma levels, and higher plasma levels of fat-soluble vitamins D and E

RELiZORB demonstrated1:

  • An increase in fat absorption and overall caloric intake||,¶
  • An increase in plasma levels of omega-3 fatty acids DHA and EPA (p<0.05) compared with animals receiving EN not administered through RELiZORB||,¶
  • Higher plasma levels of fat-soluble vitamins D and E compared with animals receiving EN not administered through RELiZORB

The clinical significance of these findings has not been determined.1

RELiZORB in preclinical models of short bowel syndrome (SBS)

Continuous Study1,5,#

Evaluated RELiZORB for improvement in fat and nutrient absorption with continuous tube feedings.

Bolus Study5,**

Evaluated use of RELiZORB in conjunction with bolus tube feedings in weaning parenteral nutrition (PN).

The decrease in PN calories coincided with an increase in enteral nutrition (EN) Advancement5,**

The decrease in PN calories coincided with an increase in enteral nutrition (EN) advancement

RELiZORB demonstrated5,6:

  • Enhanced nutrient absorption and similar coefficient of fat absorption (CFA) compared to unresected control group#,††
  • A higher average EN advancement (66% vs 47% increase in EN calories, P<0.0001) compared to control animals receiving EN not administered through RELiZORB**
  • A 19% greater reduction in PN calories (95% CI: 15%-24%, P<0.0001) compared with control animals receiving EN not administered through RELiZORB**
  • A significant increase in intestinal length (19.5% vs 0.7%, P=0.03) compared with control animals receiving EN not administered through RELiZORB**,‡‡

The clinical significance of these findings has not been determined.1

||Study conducted in a porcine model measured results of a single tube feeding (500 mL; 120 mL/hr) administered through RELiZORB over 24 hours compared to an identical tube feeding that was not administered through RELiZORB.1

¶Parallel group study conducted in a porcine model measured results of nightly tube feedings (750 cal) administered over 12 consecutive days with (n=6) and without (n=5) use of RELiZORB.1

**Parallel study conducted in a porcine model consisting of 2 groups: 75% intestinal resection (n=6) and 75% resection plus RELiZORB (n=5). PN was initiated post-operatively and was decreased as EN was advanced. EN was delivered daily via 6 bolus feeds with or without RELiZORB for 14 days.1

††No statistically significant difference in CFA between resected animals receiving RELiZORB and unresected animals in control (87.1% vs 95.2%, p=0.19).1

‡‡In the preclinical study, intestinal length increased on average by 68.4 ± 19.1 cm (19.5 ± 5.5%) compared with 0.8 ± 18.3 cm (0.7 ± 5.2%) in the control group (P=0.03).5

Patients can get more nutrition from their tube feeds

RELiZORB is proven to hydrolyze available fats, including medium-chain triglycerides (MCTs) and long-chain triglycerides (LCTs).1,7

  • LCTs are complex and contain essential fatty acids
  • Compared to MCTs, LCTs are harder to hydrolyze but provide ~10% more calories
  • RELiZORB is intended to provide continuous fat hydrolysis during tube feeding

Please see list of compatible formulas.

RELiZORB (iMMOBILIZED lipase) feeding tube

See how patients are navigating RELiZORB

Patient stories

DHA=docosahexaenoic acid; EPA=eicosapentaenoic acid; LS=least-square.

References: 1. RELiZORB. Instructions for use. Alcresta Therapeutics, Inc; 2023. 2. 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 3. Harris WS, Sands SA, Windsor SL, et al. Omega-3 fatty acids in cardiac biopsies from heart transplantation patients: correlation with erythrocytes and response to supplementation. Circulation. 2004;110(12):1645-1649. doi:10.1161/01.CIR.0000142292.10048.B2 4. 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 5. 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 6. Tsikis ST, Fligor SC, Secor JD, et al. An in-line digestive cartridge increases enteral fat and vitamin absorption in a porcine model of short bowel syndrome. Clin Nutr. 2022;41(5):1093-1101. doi:10.1016/j.clnu.2022.03.026 7. Shah ND, Limketkai BN. The use of medium-chain triglycerides in gastrointestinal disorders. Practical Gastroenterol. 2017;41(2):20-28.

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 bolus syringe push. 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.