Warnings & Cautions

Warnings

• RELiZORB is for use with enteral feeding only.
• RELiZORB should not be connected to any intravenous (IV) line, set up, or system.
• Medications should not be administered through the RELiZORB cartridge. Do not add medications to the enteral feed line in between the pump and RELiZORB (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 the RELiZORB cartridge. Any compromise of the structural integrity of RELiZORB may lead to improper connection to enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes, enteral formula leakage or risk of contamination.
  
• Do not use RELiZORB after the date marked on the pouch.
  
• Enteral formulas containing insoluble fiber should NOT be used. Insoluble fiber may clog the RELiZORB cartridge. A detailed listing of enteral formulas compatible with RELiZORB can be found here.
  
• RELiZORB is designed for use with enteral feeding pump systems with low flow/no flow alarms. RELiZORB is NOT intended for use with gravity feed systems. A detailed listing of pumps, enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes compatible with RELiZORB can be found here.
  
• 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.