EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product indicated for the clinical dietary management of enteropathy under physician supervision for the following:
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 5g of SBI and other ingredients dextrose (5g) and trace amounts 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).