Description
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.
Before Using
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.
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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.
Proper Use
Take EnteraGam™ exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
You may take EnteraGam™ with or without food.
To use:
- Empty packet of powder into a cup or a glass.
- Add at least 4 oz (120 mL) of water (or other liquid as preferred).
- Avoid hot liquids.
- Stir until fully mixed and drink immediately. Do not shake.
- You may also mix the powder with foods such as pudding or yogurt.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (powder):
- For clinical dietary management of enteropathy:
- Adults—One packet per day, taken as a single dose, or in divided doses in the morning and evening. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 packets per day.
- Children 2 years of age and older—One-half packet per day, as a single dose or in divided doses.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For clinical dietary management of enteropathy:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your to see if EnteraGam™ is working properly and to decide if you should continue to take it.
Call your doctor right away if you have shortness of breath or trouble breathing after taking EnteraGam™.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Shortness of breath
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Difficulty having a bowel movement (stool)
- headache
- increased urination
- nausea
- stomach cramps
Incidence not known
- Itching or skin rash (mild)
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20110230
