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

Also tell your doctor if you have diabetes, high blood pressure, liver disease, 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 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 medication, 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 you can safely receive this medication, tell your doctor if you have any of these other conditions:

  • 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.

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

Gadobutrol can pass into breast milk and may harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a 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 medication 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 any of these 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.

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;

  • seizure (convulsions);

  • breathing problems;

  • pounding heartbeats or fluttering in your chest; or

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

Less serious side effects may include:

  • headache, dizziness;

  • dry mouth, nausea, vomiting;

  • feeling unusually hot;

  • unusual or unpleasant taste in your mouth;

  • numbness or tingly feeling;

  • mild itching or rash; 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 Vascular Magnetic Resonance Imaging:

To detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system:
0.1 mL/kg body weight (0.1 mmol/kg) as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second. Flush the intravenous cannula with physiological saline solution after the injection.

Usual Pediatric Dose for Vascular Magnetic Resonance Imaging:

2 years of age and older:
To detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system:
0.1 mL/kg body weight (0.1 mmol/kg) as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second. Flush the intravenous cannula with physiological saline solution after the injection.

What other drugs will affect gadobutrol?

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. Many other drugs (including some over-the-counter medicines) can harm your kidneys. You may need dose adjustments or special tests if you have recently used any of these medications, such as:

  • lithium (Eskalith, Lithobid);

  • methotrexate (Rheumatrex, Trexall);

  • pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  • medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  • IV antibiotics such as amphotericin B (Amphotec, AmBisome, Abelcet), amikacin (Amikin), bacitracin (Baci IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  • antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), foscarnet (Foscavir), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte); or

  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

There may be other drugs that can affect gadobutrol. 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 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: 1.02. Revision Date: 2013-11-27, 4:54:20 PM.

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