The product information provided in this site is intended for residents of the United States.

Tired of Living Your Life Around the Issues of IBS-D or IBD?

EnteraGam® is a prescription medical food product for the dietary management of specific intestinal disorders (called enteropathy) that can cause abdominal discomfort, bloating, or diarrhea, such as irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD).1-4

EnteraGam® works differently

EnteraGam® uniquely binds microbial components, such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic loose and frequent stools in people with IBS-D or IBD.1,5

EnteraGam® Patient Support & Pharmacy Services

This program offers prescription co-pay savings vouchers, personalized pharmacy services, and other helpful information.

Learn more at The Hub

EnteraGamHub

References
  1. Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of  enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
  2. IBS with diarrhea. International Foundation for Functional Gastrointestinal Disorders Web site. http://www.aboutibs.org/site/signs-symptoms/diarrhea. Updated February 26, 2015. Accessed February 1, 2016.
  3. Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501-523.
  4. Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104(2):465-483.
  5. Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12(suppl 1):111-117.

Intended Use

EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product intended to provide for distinctive nutritional requirements that are unique for the clinical dietary management of specific intestinal disorders [e.g., in irritable bowel syndrome with diarrhea (IBS-D), inflammatory bowel disease (IBD), and HIV-associated enteropathy]. EnteraGam®, as a medical food, must be used under physician supervision.

Important Safety Information:

EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any component of EnteraGam® should not take this product. The most commonly reported adverse events in clinical studies (incidence of 2%-5%) include mild nausea, constipation, stomach cramps, headache, and increased urination. EnteraGam® has not been studied in pregnant or nursing women, so the choice to administer EnteraGam® for patients who are pregnant or nursing is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk products such as lactose, casein, or whey. It is gluten-free, dye-free, and soy-free. EnteraGam® contains 5 g of SBI and other ingredients such as dextrose (5 g) and trace amounts of sunflower lecithin.

Please see full Prescribing Information including contraindications.

To report suspected adverse events, please contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372).

You are encouraged to report negative side effects to your doctor and the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).