EnteraGam

Immune globulin bovine is a medical food that is used for clinical dietary management of enteropathy (intestinal or bowel problems) in patients who have a limited or impaired capacity to ingest, digest, absorb, or metabolize food or certain nutrients. It is also used to help patients manage chronic loose or frequent stools (eg, diarrhea-predominant irritable bowel syndrome (IBS-D), HIV-associated enteropathy).

This medical food is available only with your doctor's prescription and must be taken under the supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of EnteraGam™ in children.

Geriatric

Although appropriate studies on the relationship of age to the effects of EnteraGam™ have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to beef—Should not be used in patients with this condition.

No significant interactions have been observed between EnteraGam and other commonly prescribed medications. In addition, no specific food effects on the activity of EnteraGam have been noted.

Enteragam has only been detected in the gastrointestinal tract, and is not absorbed into the blood stream.

The active ingredient in EnteraGam is a beef-derived protein. This medical food should not be given if you are allergic to beef or have had a severe allergic reaction to any other active or inactive ingredient. If you experience shortness of breath, immediately discontinue the product and contact your healthcare provider.

Active ingredient: serum-derived bovine immunoglobulin/protein isolate, SBI

Inactive ingredients: dextrose; sunflower lecithin

Read more: Inactive ingredients

EnteraGam is contraindicated for patients with a hypersensitivity (allergy) to beef or any components in EnteraGam.

EnteraGam contains beef protein; therefore, patients who have an allergy to beef or any component of EnteraGam should not take this product.

No significant interactions of EnteraGam with commonly prescribed medications or therapies have been observed.

1 21 USC Section 360ee(b)(3).

EnteraGam packets contain a light-colored powder available as 5 g SBI including other ingredients 5 g dextrose and trace amounts of sunflower lecithin in 10 g net weight individual retail packets. Read more: Inactive ingredients

†Product: 53703-100-03
# Size: 30 packets per box

EnteraGam packets contain a light-colored powder available as 5 g SBI including other ingredients 5 g dextrose and trace amounts of sunflower lecithin in 10 g net weight individual sample packets. (Not for resale).

†Product: 53703-100-01
# Size: 3 packets per box

Store packets at 20-25°C (68-77°F): excursions permitted between 15-30°C (59-86°F). [see USP Controlled Room Temperature].

†Entera Health, Inc. does not represent this product code to be a National Drug Code (NDC) number. Instead, Entera Health has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.