Gadavist

The active ingredient in Gadavist is gadobutrol. Gadobutrol (Gadavist) is a contrast media that contains gadolinium. It is used in conjunction with an MRI scan to assist your radiologist in better diagnosing your medical problem by revealing the locations of abnormal tissues in your body.

It is used to help diagnose certain disorders of the brain and spine (central nervous system or CNS), or the blood vessels of the kidneys, and the heart. It can also help find the presence of breast cancer cells.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Gadavist. However, the following is a synopsis of the general guidelines for the use of Gadavist:

• Gadavist is administered as an infusion into a vein. This injection will be given to you by a healthcare provider in a clinic or hospital.
• Inform your provider if you have any burning, pain, or swelling around the IV needle after the medicine is injected.

Some mild or common side effects of Gadavist seen in clinical trials include:

• Headache.
• Nausea.
• Dizziness.
• Changes in taste (dysgeusia).
• Paresthesia (tingling, numbness, burning, or prickling in the skin).
• Injection site reactions such as skin redness (erythema) and pain.

Some individuals may experience serious side effects while using Gadavist. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe skin, muscle, or organ thickening. The risk is typically higher for people with chronic severe kidney disease or acute kidney injury. Symptoms include red areas, swelling, itching, skin hardening, discomfort, joint ache, and muscle weakness.
• Allergic reactions include skin rash, itching, hives, shortness of breath (dyspnea), and swelling.

These are not all of the possible adverse reactions of Gadavist. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the U.S. Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Gadavist, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Kidney problems.
• Diabetes.
• High blood pressure.
• Liver disease.
• Asthma or allergies.
• Over 60 years of age.

Boxed Warning

Gadolinium-based contrast agents (GBCAs) have been linked to nephrogenic systemic fibrosis (NSF) in patients with low kidney function. NSF is a dangerous, sometimes fatal illness that produces fibrosis of the skin, muscles, and organs. Use should be avoided in high-risk individuals unless absolutely required, and the lowest prescribed dose should be administered with adequate clearance time before repeat administration. Individuals with severe chronic renal disease (GFR <30) or acute kidney damage are most at risk. Patients, particularly older adults or those with hypertension or diabetes, should be examined for renal issues, and their GFR should be measured with lab testing before treatment.

NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.

A previous hypersensitivity reaction to gadavist or similar contrast media.

Gadavist works immediately after injection because it is a contrast agent used in MRI scans. It does not treat a specific ailment, but rather improves the appearance of blood vessels, tissues, and organs on MRI pictures. The impact occurs during the imaging procedure and is immediately eliminated from the body via the kidneys.

When Gadavist is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions.

Gadavist (gadobutrol) is generally considered safe because it is administered as a single MRI contrast injection and is not taken long-term. Unlike many medications, it has no notable drug-drug interactions.

Each milliliter of gadobutrol injection contains one millimole (mmol) of gadobutrol (Gadavist) in a single-dose vial or syringe.

Your radiologist will prescribe a recommended dose of gadobutrol (Gadavist) based on your weight. A nurse or radiologist often injects 0.1 mL/kg body weight into the veins on imaging day.

Store at room temperature and keep out of reach of children.

Bayer is the company that manufactures Gadavist.

There are several lower-cost generic versions available of Gadavist.

Gadavist is not a routine drug; instead, it is administered as a single injection during an MRI scan to improve image quality. There's no need to "stop" it because the body spontaneously eliminates it via the kidneys, generally within a day. If you have kidney problems or have had adverse effects, your doctor will follow up with you and may recommend that you avoid further scans.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.