EnteraGam

Generic name: Serum-derived Bovine Immunoglobulin/protein Isolate

Usage of EnteraGam

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 part of ongoing care to ensure adequate nutritional needs are met in those who cannot achieve adequate nutrition by normal dietary intake. Ingredients in medical foods must be generally recognized as safe (GRAS) by the FDA.

According to the FDA, medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs. For example, medical foods do not have to undergo premarket review or approval. Medical foods must comply with all applicable FDA requirements for foods, including the Current Good Manufacturing Practice regulations. FDA does not maintain a list of medical food products.

EnteraGam side effects

EnteraGam common side effects include:

mild nausea

constipation

flatulence

stomach cramps

headache

increased urination

These side effects were reported in 2 to 5 of every 100 patients (2 to 5% incidence). To date, serious side effects with EnteraGam have not been reported in clinical trials.

EnteraGam has not been studied in pregnant or nursing women.

Call your doctor for medical advice about side effects. You can report side effects to FDA by calling 1-800-FDA-1088.

Before taking EnteraGam

Before you receive EnteraGam, tell your healthcare professional about all of your medical conditions. This includes:

if you are allergic to beef or beef-products.

if you are pregnant or plan to become pregnant. Your doctor will decide if the benefit of EnteraGam for you outweighs any risk to your baby.

if you are breastfeeding or plan to breastfeed. Your doctor will decide if the benefit of EnteraGam for you outweighs any risk to your baby.

How to use EnteraGam

Drug Dose: Adult Dose: Children 2 years and older Serum-derived bovine immunoglobulin/protein isolate (SBI) Initially, one packet daily, which may be increased up to 4 packets per day as directed by your doctor. Stir one packet into at least 4 ounces of water or other liquid (not hot); do not shake. Take each dose immediately after mixing. Do not store mixed product. May also mix into yogurt or pudding instead of liquid. May divide into two doses to be taken once in the morning and once in the evening as directed by your doctor. Children 2 years and older can be administered one half (1/2) packet of EnteraGam once daily or in divided doses in liquids or food according to the doctor’s instructions.

EnteraGam has been safely used in various clinical studies up to 1 year in length among adults and children and has no restrictions on the length of therapy.

If you have additional questions about EnteraGam, you can ask your healthcare provider for a package insert that is written for healthcare providers.

What other drugs will affect EnteraGam

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.

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