Choletec (Intravenous)

Technetium Tc 99m mebrofenin injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that might be used to find and treat certain diseases or to study how the body's organs function.

Technetium Tc 99m mebrofenin injection is used to help your doctor take images of your liver, gallbladder, and bile duct to check how well they are working.

This medicine should only be given by or under the direct supervision of a doctor with specialized training in nuclear medicine.

It is very important that your doctor monitors you closely while you are receiving this medicine. This will help your doctor determine if the medicine is working correctly and decide if you should keep receiving it.

This medicine may cause serious allergic reactions. Contact your doctor immediately if you experience a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after the injection.

You will be exposed to radiation when you receive this medicine. Discuss any concerns you have about this with your doctor.

In deciding to use a diagnostic test, you and your doctor must consider the risks of the test against the benefits it provides. Other factors may also influence test results. For this test, please take note of the following:

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 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 have not been conducted on how age affects the results of technetium Tc 99m mebrofenin injection in children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how age affects the effects of technetium Tc 99m mebrofenin injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In such cases, your doctor may want 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

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this diagnostic test. Be sure to tell your doctor if you have any other medical issues, especially:

• Gallstones or
• Liver disease (including hepatitis) or
• Pancreatitis (inflammation of the pancreas)—These conditions may affect the image quality of the gallbladder.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Rare

• Chills
• hives or welts, itching, or skin rash
• nausea
• redness of the skin

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Choletec

Available Dosage Forms:

• Kit

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

A doctor or other health professional will give you this medicine. This medicine is given through a needle placed in a vein.

It is best to receive this medicine without food, at least 4 hours before or after a meal.