Gadoteridol

This information applies to the following medicines:

1. Gadodiamide (gad-oh-DYE-a-mide)

2. Gadopentetate (gad-o-PEN-te-tate)†

3. Gadoteridol (gad-oh-TER-i-dol)†

4. Gadoversetamide (gad-oh-ver-SET-a-mide)†

MRI (magnetic resonance imaging) contrast agents (also called paramagnetic 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.

MRI contrast agents are given by injection before or during MRI to help diagnose problems or diseases of the brain or the spine. In addition, gadopentetate is used to help diagnose problems in other parts of the body, such as the bones and joints, breast, liver, soft tissues, and uterus. Gadoversetamide is also used to help diagnose problems in the liver.

MRI contrast agents may also be used to diagnose other conditions as determined by your doctor.

MRI contrast agents are injected into a vein. The doses of these agents will be different for different patients depending on the weight of the person.

These agents are to be used only by or under the supervision of a doctor.

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, test results may be affected by other things. For MRI contrast agents, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to contrast agents such as gadodiamide, gadopentetate, gadoteridol, or gadoversetamide. Also, tell your doctor if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. However, in animal studies, MRI contrast agents caused a delay in development of the animal fetus, increased the risk of losing the fetus, and caused birth defects and other side effects in the offspring when these agents were given to the mother in doses many times the human dose. Also, it is not known yet what effect the magnetic field used in MRI might have on the development of the fetus. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known what amount of MRI contrast agents passes into the breast milk. However, your doctor may want you to stop breast-feeding for some time after you receive an MRI contrast agent. Be sure you have discussed this with your doctor.

Children—Although there is no specific information comparing use of MRI contrast agents in children with use in other age groups, these agents are not expected to cause different side effects or problems in children than they do in adults.

Older adults—These contrast agents have been tested and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Other medical problems—The presence of other medical problems may affect the use of MRI contrast agents. Make sure you tell your doctor if you have any other medical problems, especially:

* Allergies or asthma (history of)—If you have a history of allergies or asthma, you may be at greater risk of having an allergic reaction to the contrast agent

* Anemia or

* Low blood pressure—MRI contrast agents may make these conditions worse

* Epilepsy—There may be an increased chance of seizures

* Heart disease—There may be an increased chance of developing an irregular heart beat

* Kidney disease (severe)—Kidney disease can cause the MRI agent to stay in the body longer than usual, which may increase the chance of side effects

* Sickle cell disease—There may be a greater risk of blockage of the blood vessels in patients with this condition