Warnings & Cautions

Warnings

Using RELiZORB other than as directed may result in RELiZORB not working properly or may cause serious injury.

  • DO NOT connect RELiZORB to IV (intravenous) or other non-enteral tubes or lines. RELiZORB is ONLY for use with enteral tube feeding
     
  • 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 you accidently add medicines or flush solutions before RELiZORB, then the RELiZORB and all tubing and formula must be thrown away. You may re-start feeding using a new RELiZORB and feeding set
     
  • ​Medicines or saline flushes may only be added to the enteral feeding line after RELiZORB. Medicines may be added to the side port of a Y-connector extension set located between RELiZORB and the patient
     
  • Fibrosing colonopathy is a rare bowel disease. Your chance of having fibrosing colonopathy could increase with use of high dose pancreatic enzyme replacement therapy (PERT). PERTs are usually tablets or capsules that contain enzymes and are ingested orally. RELiZORB contains a digestive enzyme lipase which is not the same as in PERT. The lipase in RELiZORB stays attached to the white bead (iLipase) so it remains in the cartridge and does not enter your body with the enteral tube feeding formula. Follow your healthcare provider’s instructions on PERT product dosing when used with RELiZORB. Fibrosing colonopathy is a serious problem that may require surgery. Call your healthcare provider right away if you have any unusual or severe stomach area pain

 

Risks

  • There may be adverse effects or risks related to the use of RELiZORB that are not known as RELiZORB has not been tested in human clinical trials

 

Cautions

Using RELiZORB other than as directed may result in RELiZORB not working properly.

  • Do not re-use RELiZORB. Each RELiZORB should only be used once. At the end of the feeding, throw away the RELiZORB. RELiZORB may not break down fats properly if re-used
     
  • Do not break or place excess pressure on any part of the RELiZORB cartridge. Any cracks or breaks may cause RELiZORB to not connect properly to the enteral tube feeding set or may lead to formula leaking
     
  • Do not use enteral tube feeding formulas containing insoluble fiber as insoluble fiber may block the cartridge. Check the label of your feeding formula for something called insoluble fiber
     
  • Use RELiZORB only with a pump that has a low flow or no flow alarm. RELiZORB has not been tested for use with gravity feeding systems (systems that have no pumps). If you use a pump system without a low flow/no flow alarm, you may not notice if the flow of the feeding slows down or stops
     
  • Do not use more than two (2) RELiZORBs in a day (a 24-hour period). You can use two (2) RELiZORBs, one right after the other, or space out the timing of their use
     
  • Each RELiZORB may be used for up to 500 mL of enteral tube feeding formula. Do not use one RELiZORB for more than 500 mL in a feeding, as it may not work as well to break down all the fat. If you use less than 500 mL of formula in a feeding, you must throw away the RELiZORB after use
     
  • Use only with flow rates from 24 to 120 mL/hr when using RELiZORB. RELiZORB has not been tested using flow rates greater than 120 mL/hr or less that 24 mL/hr. Using a flow rate outside of this flow rate range may affect how well RELiZORB breaks down fat
     
  • RELiZORB has been tested for up to a 15 minute stop in feeding and shown not to change flow rate or how well RELiZORB breaks down fat. The impact of stopping the feeding with RELiZORB for longer than 15 minutes has not been tested
     
  • Do not freeze RELiZORB. Store RELiZORB in its pouch either refrigerated or at room temperature (2°C to 27°C; 36°F to 80°F) until you are ready to use it. Storing RELiZORB in a hot place (greater than 27°C or 80°F) may affect how well RELiZORB breaks down fat
     
  • Do not use RELiZORB after the “use by” date marked on the pouch. If RELiZORB is used after the “use by” date, RELiZORB may not break down fats as well