What is RELiZORB?
RELiZORB is a medical device designed to assist in the digestion of fats within enteral formulas for patients with exocrine pancreatic insufficiency (EPI). It is a single-use cartridge containing an immobilized lipase enzyme (iLipase) bound to polymeric beads. The cartridge is connected in-line with the existing enteral feeding pump circuit. As the enteral formula passes through, the iLipase hydrolyzes the fats into absorbable fatty acids and monoglycerides before they enter the patient's body. This device is indicated for use in pediatric (ages 1 year and above) and adult patients to improve fat absorption, particularly those with conditions like cystic fibrosis.
The Absence of Official Medical Contraindications
While many medications and treatments have specific medical conditions that outright prohibit their use (contraindications), RELiZORB differs significantly as it is a device containing an immobilized enzyme that does not get ingested by the patient. Because the lipase remains contained within the cartridge and is not a pharmaceutical drug absorbed by the body, there are no official, published medical contraindications listed in the product's instructions for use or regulatory summaries. Instead, all safety guidelines focus on proper handling and usage of the device itself.
Critical Warnings and Precautions for RELiZORB Use
Despite the lack of formal medical contraindications, several important warnings and precautions must be followed to ensure the device works correctly and to prevent patient harm. These are often viewed as functional or situational contraindications and are detailed in the product's official instructions.
Improper Connection and Administration
- Enteral use only: RELiZORB is explicitly for use with enteral feeding and must not be connected to an intravenous (IV) line or any other non-enteral system. Misuse could result in serious injury.
- No reuse: The cartridge is a single-use product. Reusing the device can lead to contamination and may compromise its effectiveness.
- Not for gravity feeding: The device is designed for use with an enteral pump system. It is not intended for use with gravity-fed systems.
- Do not use past expiration: The 'use by' date on the pouch should always be checked. Using an expired cartridge may result in it not effectively breaking down fats.
Incompatible Formulas and Substances
- Insoluble fiber: Enteral formulas containing insoluble fiber should not be used with RELiZORB, as this can clog the cartridge and prevent proper function. A list of compatible formulas is available on the manufacturer's website.
- Blenderized formulas: The instructions for use also specify that blenderized formulas should not be used with the device.
- Medications and flushes: Neither medications nor flush solutions should be administered through the RELiZORB cartridge. Introducing medications before the cartridge can adversely affect both the medication and the lipase's function. If this occurs, the cartridge must be discarded and replaced.
Special Patient Considerations
- Fibrosing Colonopathy: Patients with cystic fibrosis receiving high-dose pancreatic enzyme replacement therapy (PERT) have a rare risk of fibrosing colonopathy. While RELiZORB's lipase is not porcine-sourced and does not contain PERT, patients with a history of this condition should be monitored closely by a physician.
- Concomitant PERT: The safety and efficacy of using RELiZORB simultaneously with porcine PERT has not been fully investigated. Clinical guidance from a physician is necessary for managing both therapies.
What to Do If a Warning is Violated
If a mistake is made during setup or administration, it is crucial to follow the manufacturer's guidance to minimize risk.
- If medication or a flush is added before the cartridge: Immediately stop the feed. Discard the cartridge and replace it with a new one. Medications should be administered via a separate port on the feeding line located after the RELiZORB cartridge.
- If the cartridge is dropped or appears damaged: Do not use it. Replace with a new, undamaged cartridge to ensure efficacy and prevent contamination.
- If formula with insoluble fiber is used: The cartridge should be discarded as it may be clogged or its function impaired.
Comparison of Correct and Incorrect RELiZORB Use
| Aspect | Correct Usage | Incorrect Usage | Consequence |
|---|---|---|---|
| Route of Administration | Enteral feeding tube only | Connected to an intravenous (IV) line or other non-enteral tubes | Serious patient harm or injury |
| Medication Administration | Through a separate port after the cartridge | Added to the enteral feed line before the cartridge | Compromised medication effectiveness and impaired RELiZORB function |
| Cartridge Reusability | Use once, then discard | Reuse for multiple feedings | Contamination risk and reduced fat hydrolysis efficacy |
| Formula Compatibility | Compatible enteral formulas without insoluble fiber | Formulas containing insoluble fiber or blenderized formulas | Clogging of the cartridge and device malfunction |
| Cartridge Condition | Use within expiration date, in sealed pouch | Use past expiration date or with damaged pouch | Reduced enzymatic activity and potential contamination |
Conclusion
While there are no true medical contraindications for RELiZORB, safety hinges on adhering to strict usage guidelines rather than a patient's medical history. The focus is on preventing improper use of the device, incompatible substances, and potential interactions. Healthcare providers and patients must be vigilant about connecting the device correctly for enteral use only, avoiding the administration of medications through the cartridge, and using compatible formulas. By following these essential warnings and precautions, patients can effectively utilize RELiZORB to improve fat absorption and overall nutritional status safely.
For more detailed information, consult the official FDA De Novo summary: FDA De Novo Summary (DEN150001).
Conclusion Summary
In conclusion, RELiZORB, a medical device for assisting fat digestion during enteral feeding, does not have any published medical contraindications. Instead, its use is governed by crucial warnings and precautions focused on proper administration, formula compatibility, and device handling. Key warnings include never using the device intravenously, avoiding the administration of medications through the cartridge, and never reusing the device. Adhering to these guidelines is vital for ensuring both the safety and effectiveness of the treatment for patients with exocrine pancreatic insufficiency, such as those with cystic fibrosis. Healthcare providers should ensure that patients and caregivers are fully trained on proper usage and troubleshooting, particularly regarding medication administration and formula compatibility, to maximize the therapeutic benefits and minimize risks.
