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gadobutrol

Generic Name: gadobutrol (GAD oh BUE trol)
Brand Name: Gadavist

What is gadobutrol?

Gadobutrol 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.

Gadobutrol is used to help diagnose certain disorders of the brain and spine (central nervous system). Gadobutrol is also used with MRI of the breast to help detect breast cancer.

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

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

Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Before receiving this medicine, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadobutrol. Also tell your doctor if you have recently received any contrast agents similar to gadobutrol.

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What should I discuss with my healthcare provider before receiving gadobutrol?

Gadobutrol 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 medicine, tell your doctor if you have kidney disease or if you are on dialysis. You may not be able to receive gadobutrol. Also tell your doctor if you have recently received any contrast agents similar to gadobutrol.

To make sure gadobutrol is safe for you, tell your doctor if you have:

  • diabetes;

  • high blood pressure;

  • liver disease;

  • asthma, hay fever, or a history of food or drug allergies;

  • a history of seizures;

  • 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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed within 18 hours after using gadobutrol. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

How is gadobutrol given?

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

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

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

What happens if I overdose?

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

What should I avoid after receiving gadobutrol?

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

Gadobutrol side effects

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

Some side effects of gadobutrol may occur up to several days after injection.

Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

  • 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.

Also call your doctor at once if you have:

  • kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

  • severe pain, burning, or irritation around the IV needle.

Common side effects may include:

  • headache;

  • unusual or unpleasant taste in your mouth;

  • nausea; or

  • cold feeling, warmth, pain, 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)

Gadobutrol dosing information

Usual Adult Dose for CNS Magnetic Resonance Imaging:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use: Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Usual Adult Dose for Diagnostic:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use: Indicated for use with MRI to assess the presence and extent of malignant breast disease.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injection
Comments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.

Use:
-Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

What other drugs will affect gadobutrol?

Other drugs may interact with gadobutrol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about gadobutrol.
  • 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: 2.01. Revision Date: 2015-02-02, 9:24:52 AM.

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