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

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Frequently Asked Questions

RELiZORB is indicated for use in pediatric patients (ages 2 years and above) and adult patients to hydrolyze fats in enteral formula1

Why did RELiZORB change?  

Not every tube-fed patient has the same approach to feeding. To better support the needs of tube-fed patients, RELiZORB has been redesigned for expanded utilization.1 

 

How can I tell which RELiZORB is new? 

RELiZORB has a new look for both the product and packaging—look for the orange cap on the new RELiZORB cartridge.1 

 

Can RELiZORB be used the same way as before?  

Yes. RELiZORB connects directly to your patient’s feeding tube and is still ENFit® compatible. The updated RELiZORB cartridge offers expanded utilization options, including use of up to 6 RELiZORB cartridges per day and use of RELiZORB with both continuous and bolus feeding approaches. Do not use more than 6 cartridges in a 24-hour period. See full Instructions for Use at www.relizorb.com.1 

 

Can RELiZORB be used with the same formulas?  

Yes. In addition, RELiZORB is now compatible with an expanded range of formulas, including some with insoluble fiber. Click here to see a list of formulas and pumps that are compatible with RELiZORB.1

 

Does RELiZORB still contain iLipase®? 

RELiZORB still contains iLipase, the digestive enzyme lipase attached to small microbead carriers, which breaks down fats in enteral formula as it passes through the cartridge, delivering absorbable fats to your patient’s body. The iLipase remains in the cartridge and is not ingested.1

 

Is the new RELiZORB safe and effective?  

Yes. There are no changes to the safety or efficacy of RELiZORB, and it is still the only FDA-cleared enzyme product that breaks down fats in enteral formula.1,2

 

Where can I learn more about the new product? 

Check out the new updates page here.

 

Are there changes to how RELiZORB is reimbursed?  

There are no changes to billing or coding. 

 

When will my patients receive the new RELiZORB?  

Patients who are prescribed RELiZORB will receive the updated RELiZORB from their specialty pharmacy in the coming months. They will receive communications from RELiZORB Support Services to ensure they are prepared for the transition. Patients should continue to feel confident using their existing RELiZORB product the same way they always have, as directed by their healthcare provider. For more information about when you and your patients may expect to see the next-generation RELiZORB, please see the Customer Letter.

 

Do current RELiZORB patients need to be re-enrolled in RELiZORB Support Services?  

No. Current patients that are already receiving RELiZORB and enrolled in RELiZORB Support Services will not need a new authorization.

What is RELiZORB?

RELiZORB is a digestive enzyme cartridge that contains the enzyme lipase. RELiZORB is used with enteral tube feeding to help break down the fats in enteral formula. Lipase is an enyzme that is normally made in the body to break down fats (triglycerides) into absorbable forms (fatty acids and monoglycerides). The lipase enzyme used in RELiZORB is attached to white beads (iLipase®), which are visible through the side of the cartridge.1

 

What does RELiZORB do?

Properly breaking down and absorbing fats is important for normal growth and development. RELiZORB contains a digestive enzyme called lipase that breaks down fats in enteral tube-feeding formula into an absorbable form as the formula passes through the RELiZORB cartridge.1,3,4

 

How can RELiZORB help with enteral tube feedings?

Some people may have trouble digesting the fats in enteral formula. In clinical studies, RELiZORB was shown to increase the amount of fat the body absorbs from enteral tube-feeding formulas, particularly omega-3 fatty acids.1,5

 

Why doesn’t enteral formula contain absorbable fats?

Fats that are broken down into their absorbable form are not stable and spoil quickly. Therefore, enteral tube-feeding formulas are made with fat in triglyceride form, which does not spoil as quickly but also is not absorbable by the body. RELiZORB breaks down the fats into absorbable forms (fatty acids and monoglycerides) during enteral tube feeding.1,6,7

 

How does RELiZORB connect to a tube-feeding setup?

RELiZORB is easy to use. It is ENFit® compatible and quickly connects in-line directly to the patient’s feeding tube. See the Instructions for Use for full information on product setup and use.1

Learn more in the RELiZORB Patient Guide.

 

What pumps can be used with RELiZORB?

RELiZORB must be used with enteral tube-feeding pumps that have low-flow/no-flow alarms. A list of pumps tested with RELiZORB can be found here.1

 

How much formula can each RELiZORB cartridge be used with?

The volume of formula that can be used with RELiZORB is dependent on the patient’s feeding setup.  See the different feeding setups and corresponding feeding volumes here, or read the Instructions for Use for RELiZORB.1

 

Can medicines be added to enteral tube feeding?

If medications need to be added to a tube-feeding line, they must be added to the line after RELiZORB. Medicines or saline flushes may be added to the side port of a Y-connector extension set located between RELiZORB and the patient.1

Do not place medicines in the enteral tube-feeding bag or anywhere else before the RELiZORB cartridge. Passing medicines through RELiZORB may change how the medicine works or how RELiZORB breaks down fats. If the patient accidentally adds medicines or flushes solutions before RELiZORB, then the RELiZORB cartridge and all tubing and formula must be thrown away. The patient may restart the feeding using a new RELiZORB cartridge and feeding set.1

 

Can RELiZORB be used more than once?

No. Do not reuse RELiZORB. Each RELiZORB cartridge should only be used once. At the end of the feeding, throw away the RELiZORB cartridge. RELiZORB may not break down fats properly if it is reused.1

 

How many RELiZORB cartridges can be used in a day?

Do not use more than six (6) RELiZORB cartridges in a day (24-hour period).1

 

Learn more in the RELiZORB Instructions for Use and Patient Guide. 

Is RELiZORB covered by health insurance? 

A RELiZORB Support Services Program Coordinator will work with your patient’s insurance provider to help determine whether RELiZORB is covered by your patient’s health insurance.

 

What if my patient’s insurance provider does not cover RELiZORB? 

If your patient’s insurance plan has denied coverage for RELiZORB, you can encourage your patient to reach out to a RELiZORB Support Services Program Coordinator at 1-844-632-9271 or email [email protected]. 

For healthcare professionals, a Clinical Documentation Checklist, Peer-to-Peer Preparation Guide, and Letter of Medical Necessity Templates are available. 
 

How will your patient get RELiZORB? 

Once RELiZORB is prescribed and the Patient Enrollment Form is completed, your patient will be contacted by a RELiZORB Support Services Program Coordinator to get all the information necessary to get them started on RELiZORB and to make sure they receive shipments as expected. If you or your patient have any questions, call RELiZORB Support Services at 1-844-632-9271 or email [email protected]. 

 

How does my patient refill their RELiZORB prescription? 

To refill their RELiZORB prescription, please have your patient call their RELiZORB Support Services Program Coordinator at 1-844-632-9271 or email [email protected], and they will provide them with contact information for a specialty pharmacy that can dispense the product. Patients can also contact the specialty pharmacy directly for their refill. 

 

What if my patient can’t afford the co-pay for RELiZORB? 

For eligible patients with commercial health insurance, the RELiZORB Out-of-Pocket Assistance Program assists with out-of-pocket expenses, which can include co-pays, coinsurance, or deductibles. 

Enrollment in the program is subject to confirmation of eligibility. RELiZORB Support Services will review your patient’s commercial health insurance benefits, and if they are eligible, they will be enrolled in the program. 

 

How do I reach my RELiZORB Support Services Program Coordinator? 

Call RELiZORB Support Services at 1-844-632-9271 or email [email protected]. 

 

What if I have questions about RELiZORB? 

RELiZORB Support Services can help with information and resources that can help address questions you may have. Call 1-844-632-9271 or email [email protected]. 

 

Does RELiZORB have an HCPCS billing code? 

Effective January 1, 2019, RELiZORB has a permanent, separately billable Medicare billing code (B4105). In addition, RELiZORB was assigned the PE04 (Enteral Equipment and/or Supplies) Product and Service Code, which may be relevant for certain patients under the July 11, 1984, Medicare National Coverage Determination for Enteral and Parenteral Nutritional Therapy (180.2). 

Learn more on the RELiZORB Support Services page.

HCPCS=healthcare common procedure coding system.

References: 1. RELiZORB. Instructions for use. Alcresta Therapeutics, Inc; 2023. 2. 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. 3. 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 4. 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 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. 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 7. 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

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.
See more
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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.