gadopentetate dimeglumine

What is the most important information I should know about gadopentetate dimeglumine?

Gadopentetate dimeglumine can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• deep bone pain in your ribs or your hips;
• trouble moving; or
• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadopentetate dimeglumine.

Also tell your doctor if you have diabetes, high blood pressure, liver disease (or liver transplant), asthma or allergies, if you are over 60 years old, if you have ever had a reaction to a contrast agent, or if you have recently had an injury, surgery, or severe infection.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

Some of the side effects of gadopentetate dimeglumine can occur up to 48 hours after you have received the medication.

What is gadopentetate dimeglumine?

Gadopentetate dimeglumine is a contrast agent that produces magnetic effects. It is used in combination with magnetic resonance imaging (MRI) to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on the MRI.

Gadopentetate dimeglumine is used to help diagnose certain disorders of the heart, brain, blood vessels, and spinal tissues.

Gadopentetate dimeglumine may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving gadopentetate dimeglumine?

Gadopentetate dimeglumine can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• deep bone pain in your ribs or your hips;
• trouble moving; or
• skin redness or discoloration.

Before receiving this medication, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadopentetate dimeglumine.

To make sure you can safely receive this medication, tell your doctor if you have any of these other conditions:

• diabetes;
• high blood pressure;
• liver disease (or liver transplant);
• asthma, hay fever, or a history of food or drug allergies;
• if you are over 60 years old;
• if you have ever had any type of reaction to a contrast agent; or
• if you have recently had an injury, surgery, or severe infection.

FDA pregnancy category C. It is not known whether gadopentetate dimeglumine will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

Gadopentetate dimeglumine can pass into breast milk and may harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is gadopentetate dimeglumine used?

Gadopentetate dimeglumine is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting during your MRI.

Your doctor or other healthcare provider may want to watch you for a short time after your test is over. This is to make sure you do not have any unwanted side effects or delayed reactions.

What happens if I miss a dose?

Since gadopentetate dimeglumine is used only during your MRI, you will not be on a dosing schedule.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving gadopentetate dimeglumine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of gadopentetate dimeglumine?

Some of the side effects of gadopentetate dimeglumine can occur up to 48 hours after you have received the medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• urinating less than usual or not at all;
• drowsiness, confusion, mood changes, increased thirst, loss of appetite;
• swelling, weight gain, feeling short of breath; or
• swelling, irritation, or skin changes where the injection was given.

Less serious side effects may include:

• headache;
• dizziness; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect gadopentetate dimeglumine?

This medication can harm the kidneys in certain people, and this effect may be increased if you also use other medicines harmful to the kidneys. Before you receive gadopentetate dimeglumine, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

There may be other drugs that can affect gadopentetate dimeglumine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about gadopentetate dimeglumine.

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