gadobutrol 7.5 mmol/7.5 mL (1 mmol/mL) intravenous syringe

Generic name:
Gadolinium-based contrast agent - injection

Brand name(s)
Clariscan , Dotarem , Elucirem , Eovist , Gadavist , Multihance , Prohance , Vueway

This medication may rarely cause kidney damage. The risk of kidney damage is greater if you already have kidney problems, if you are an older adult, or if you have high blood pressure or diabetes. Your doctor should check how well your kidneys are working before you receive this medication.

See also Side Effects section.

This medication is used before a magnetic resonance imaging (MRI) scan. It belongs to a class of drugs known as gadolinium-based contrast agents (GBCAs). This medication helps the MRI scan make clearer images, so your doctor can more easily diagnose your condition.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start this medication. If you have any questions, ask your health care professional.

This medication is given by injection into a vein by a health care provider. The injection is given as directed by your doctor. The dosage is based on your medical condition and weight.

Nausea, unpleasant taste, or headache may occur. If any of these effects last or get worse, tell your health care professional.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• kidney problems (such as change in the amount of urine)
• pain/swelling/redness at the injection site
• swelling ankles/feet

Get medical help right away if you have any very serious side effects, including:

• dark patches on the skin
• hardening/tightening of the skin
• joint stiffness
• hip/rib pain
• muscle weakness
• trouble moving

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your health care professional if you are allergic to it; or to other gadolinium-based contrast agents (such as gadoterate meglumine, gadoteridol, gadoxetate disodium, gadobenate dimeglumine, gadobutrol, or gadopiclenol); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease (including being on dialysis)
• diabetes
• high blood pressure

Gadolinium can stay in your body for months or years after getting this medication. Studies have not found harmful effects from gadolinium if your kidneys work normally. For more details talk to your doctor.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as kidney function) may be done before you use this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable. This medication is given once before your imaging test.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.