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

Medical Foods

Federal Medical Foods Definition

The term medical food is defined in the Orphan Drug Act as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” This definition is from section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)), as amended in 1988.

The ingredients in EnteraGam® are generally recognized as safe (GRAS).

EnteraGam® is not:

  • A dietary supplement
  • A probiotic
  • A change in diet

The specially formulated immunoglobulins in EnteraGam® are not found in the diet at sufficient quantities to manage enteropathy.

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).