gadoversetamide

Generic Name: gadoversetamide (GAD oh ver SET a mide)
Brand Name: OptiMARK

What is gadoversetamide?

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

Gadoversetamide is used to help diagnose certain disorders of the brain and spine (central nervous system), or the liver.

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

What is the most important information I should know about gadoversetamide?

Gadoversetamide 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;

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  • 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 gadoversetamide. Also tell your doctor if you have recently received any contrast agents similar to gadoversetamide.

Also tell your doctor if you have diabetes, high blood pressure, liver disease (or liver transplant), anemia or other red blood cell disorder, a heart rhythm disorder, a personal or family history of Long QT Syndrome, asthma or allergies, a history of seizures, 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.

What should I discuss with my healthcare provider before taking gadoversetamide?

Gadoversetamide 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 gadoversetamide. Also tell your doctor if you have recently received any contrast agents similar to gadoversetamide.

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);

  • a heart rhythm disorder;

  • anemia or other red blood cell disorder;

  • a history of seizures (convulsions);

  • a personal or family history of Long QT Syndrome;

  • 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 gadoversetamide will harm an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

It is not known whether gadoversetamide passes into breast milk or if it could harm a nursing baby. Do not breast-feed for at least 72 hours after receiving gadoversetamide. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

How should I take gadoversetamide?

Gadoversetamide 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.

Gadoversetamide can cause you to have unusual results with certain medical tests for 12 to 24 hours after your MRI. Tell any doctor who treats you that you have received gadoversetamide.

What happens if I miss a dose?

Since gadoversetamide 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 while taking gadoversetamide?

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

Gadoversetamide side effects

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

  • fast, uneven heart rate.

Less serious side effects may include:

  • headache, dizziness;

  • nausea, diarrhea;

  • flushing (warmth, redness, or tingly feeling);

  • unusual or unpleasant taste in your mouth;

  • numbness, burning pain, or tingling in your hands or feet; or

  • cold feeling, warmth, pain, bruising, swelling, or burning where the medicine was injected.

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.

See also: Side effects (in more detail)

Gadoversetamide dosing information

Usual Adult Dose for Magnetic Resonance Angiography:

For use with magnetic resonance imaging (MRI) in patients with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues and to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomography:

Bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection.

What other drugs will affect gadoversetamide?

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 gadoversetamide, 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 gadoversetamide. 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 gadoversetamide.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2012-08-13, 3:51:31 PM.

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