In Clinical Studies EnteraGam® Has Demonstrated Safety and Tolerability
- EnteraGam® acts within the GI tract, not systemically
- In the IBS-D study, withdrawal rates due to adverse events were similar among patients taking EnteraGam® or placebo1
- The most common reported adverse events (less than 0.2% overall) included mild nausea, constipation, headache,
increased urination, increased diarrhea, and joint pain2 - No serious adverse events attributed to EnteraGam® have been reported2
- No interactions between EnteraGam® and commonly prescribed medications2
- No restrictions on the length of therapy for EnteraGam®
References
- Wilson D, Evans M, Weaver E, Shaw AL, Klein GL. Evaluation of serum-derived bovine immunoglobulin protein isolate in subjects with diarrhea-predominant irritable bowel syndrome. Clin Med Insights Gastroenterol. 2013;6:49-60.
- EnteraGam® [product information]. Ankeny, IA: Entera Health, Inc.; October 2020.
Intended Use
EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.
Important Safety Information
EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the supervising physician.
EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.
Please see .
To report suspected adverse reactions, contact Entera Health, LLC at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
The product information provided in this site is intended for residents of the United States.
EnteraGam® is manufactured and
distributed by Proliant Health & Biologicals, LLC
©2021 Proliant Health & Biologicals, LLC
Ankeny, IA 50021
ENT100H0121 01/21
