Gadavist (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.
Gadavist is used to help diagnose certain disorders of the brain and spine (central nervous system).
Gadavist is also used with MRI of the breast to help detect breast cancer.
Important information
Gadavist 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 Gadavist. 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.
Before taking this medicine
Gadavist can cause a life-threatening condition in people with advanced kidney disease. The symptoms of this condition include:
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burning, itching, swelling, scaling, and tightening or hardening of your skin;
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muscle weakness;
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joint stiffness in your arms, hands, legs, or feet;
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deep bone pain in your ribs or your hips;
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trouble moving; or
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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 Gadavist. Also tell your doctor if you have recently received any contrast agents similar to gadobutrol.
To make sure Gadavist is safe for you, tell your doctor if you have:
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diabetes;
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high blood pressure;
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liver disease;
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asthma, hay fever, or a history of food or drug allergies;
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a history of seizures;
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if you are over 60 years old;
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if you have ever had any type of reaction to a contrast agent; or
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if you have recently had an injury, surgery, or severe infection.
It is not known whether Gadavist 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 Gadavist. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.
How is Gadavist given?
Gadavist 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 Gadavist 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 to the Gadavist injection.
Gadavist dosing information
Usual Adult Dose of Gadavist 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 of Gadavist 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 happens if I miss a dose?
Since Gadavist 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 Gadavist?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Gadavist side effects
Get emergency medical help if you have signs of an allergic reaction to Gadavist: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects of Gadavist may occur up to several days after injection.
Gadavist 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:
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burning, itching, swelling, scaling, and tightening or hardening of your skin;
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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:
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kidney problems - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or
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severe pain, burning, or irritation around the IV needle.
Common Gadavist side effects may include:
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headache;
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unusual or unpleasant taste in your mouth;
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nausea; or
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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)
What other drugs will affect Gadavist?
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.
