Immune globulin bovine (Oral)

Immune globulin bovine is a medical food used to manage enteropathy (intestinal or bowel problems) in patients who have difficulty eating, digesting, absorbing, or metabolizing food or certain nutrients. It is also used to help patients control chronic loose or frequent stools (for example, diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV-associated enteropathy).

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

It is very important that your doctor check your progress at regular visits. This will help you see if EnteraGam™ is working properly and to decide if you should keep taking it.

Call your doctor right away if you have shortness of breath or trouble breathing after taking EnteraGam™.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems that would limit the use of EnteraGam™ in children.

Geriatric

While studies on the effects of EnteraGam™ in older adults have not been conducted, no specific problems related to age have been reported so far.

Breast Feeding

There are no adequate studies on the risks to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose or take other precautions. Inform 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 taken around the time of eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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.

In the U.S.

• EnteraGam

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.

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.