Pronunciation:

man-ga-FOE-di-pir

Brand Names:

• Teslascan

Uses of This Medicine:

Mangafodipir is an MRI (magnetic resonance imaging) contrast agent (also known as paramagnetic agents). MRI agents are used to help provide a clear picture during MRI. MRI is a special kind of diagnostic procedure. It uses magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, it does not involve ionizing radiation.

Mangafodipir is given by injection before MRI to help diagnose problems in the liver.

Mangafodipir is injected into a vein. The dose of this agent will be different for different patients depending on the body weight of the person.

This medicine is to be used only by or under the supervision of a doctor.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mangafodipir in children under 12 years of age with use in other age groups.

Mangafodipir is not expected to cause different side effects or problems in teenagers than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mangafodipir in the elderly with use in other age groups.

Breast-feeding—

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.

Other medicines—

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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergies (history of) or
• Immune system problems (history of)—Possible increased risk of having an allergic reaction to mangafodipir

• Nausea or vomiting or
• Other stomach problems such as reflux (acid backing up from the stomach)—This medicine commonly causes nausea and vomiting, which could cause more problems

Proper Use of This Medicine:

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.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

Rare

Chest pain

irregular heartbeat

itching

shortness of breath

skin rash or hives

swelling of face

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:

More common

Nausea and/or vomiting

redness at place of injection

warmth at place of injection

Less common

Abdominal or stomach pain

coldness at place of injection

feeling of pressure at place of injection

dizziness

headache

pain at place of injection

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.