EnteraGam
Generic name:serum-derived bovine immunoglobulin/protein isolate
Company: Entera Health, Inc.
Treatment for: Dietary Management of Enteropathy
Overview
EnteraGam (serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product indicated for the clinical dietary management of enteropathy (bowel problems) to be used under a doctor’s medical supervision. It is given orally as a powder mixed into a liquid.
EnteraGam is indicated for:
- use in patients for the clinical dietary management of enteropathy in patients who have a limited or impaired capacity to ingest, digest, absorb, or metabolize certain nutrients.
- the clinical dietary management of enteropathy in patients with chronic loose or frequent stools (for example, diarrhea-predominant irritable bowel syndrome [IBS-D], inflammatory bowel disease [IBDD] and HIV-associated enteropathy).
Utilization of nutrition depends on appropriate digestion of food and optimal gut metabolism and absorption of nutrients. Some patients (for example, those with IBS-D or HIV-associated enteropathy) are not able to adequately ingest, digest, absorb, or metabolize food and certain nutrients, including water. Medical foods are meant to manage conditions or diseases in which there is a distinct nutritional need. EnteraGam is a ‘generally recognized as safe’ (GRAS) ingredient for enteral and/or oral administration, as designated by the FDA.
EnteraGam is labeled for use in adults and children two years of age and older. EnteraGam is contraindicated (not to be used) in patients with a hypersensitivity (allergy) to beef or any other components in the product. The active ingredient in the product is a beef-derived protein that consists of more than 50 percent immunoglobulin.
EnteraGam is manufactured and distributed by Entera Health, Inc. and has been commercially available since August 2013.
EnteraGam Formulations Available in the U.S.
| Generic Name | Brand Name | FDA-Approved Uses | Medical Food Formulation |
|---|---|---|---|
| Serum-derived bovine immunoglobulin/protein isolate (SBI) | EnteraGam by Entera Health | Clinical dietary management of an intestinal disorder known as enteropathy (e.g., in diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV-associated enteropathy); help manage chronic diarrhea and loose stools. | Active ingredient: 5 grams of SBI per packet. Inactive ingredients: 5 grams dextrose, trace amounts of sunflower lecithin. EnteraGam does not contain any milk products (lactose, casein, whey), is gluten-free, dye-free, and soy-free. |
What is a Medical Food?
Medical foods are regulated by the FDA under the Orphan Drug Act, and are specially formulated to be taken by mouth or given directly into the gastrointestinal tract (as through a tube). Medical foods are to be used under a physician’s care but are not “prescription only” products as defined by the FDA. Medical foods are pa...
