Hepatolite (Intravenous)

Technetium Tc 99m disofenin injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that can be used to detect and treat certain diseases or to examine how the body's organs are functioning.

Technetium Tc 99m disofenin injection is used to assist your doctor in viewing images of your liver, gallbladder, and bile duct to evaluate how well they are working.

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

It is very important for your doctor to monitor you closely while you are receiving this medicine. This will help your doctor see 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, or throat, difficulty breathing, or chest pain after the injection.

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

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it will provide. This is a decision for you and your doctor to make. Additionally, other factors may affect test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care 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 use of technetium Tc 99m disofenin injection in children. Safety and effectiveness have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of technetium Tc 99m disofenin injection have not been performed in older adults, there are no expected issues that would limit its usefulness in elderly patients. However, older patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and a dose adjustment for those receiving technetium Tc 99m disofenin injection.

Breast Feeding

Studies in breastfeeding women have shown harmful effects in infants. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to change the dose, or other precautions may be necessary. 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 used at or around the time of eating food or consuming certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Rare

• Chills
• nausea

Incidence not known

• Blistering, peeling, or loosening of the skin
• cough
• diarrhea
• fever
• itching at the injection site
• joint or muscle pain
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unusual tiredness or weakness

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.

• Hepatolite

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.