Pronunciation:

gad-oh-BUE-trol

Brand Names:

• Gadavist

Dosage Forms:

• Solution

Warnings:

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. The risk for NSF is greatest in patients with acute kidney injury or chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m(2). Evaluate patients for acute kidney injury or other conditions which may reduce renal function. Patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes) should have their estimate the glomerular filtration rate (GFR) determined through laboratory testing. Do not exceed the recommended gadobutrol dose in patients at highest risk for NSF. Allow sufficient time for the drug to be eliminated by the body prior to subsequent doses .

Classifications:

Therapeutic—

Diagnostic Agent, Radiological Contrast Media

Uses of This Medicine:

Gadobutrol injection is a magnetic resonance imaging (MRI) contrast agent that is used to help create a clear picture of the body during an MRI scan. MRI scans are a special kind of procedure that lets a doctor look at the inside of the body, such as the brain. They use magnets and computers to create images or “pictures” of the body. Unlike x-rays, MRI scans do not involve radiation. Gadobutrol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, breast, and other parts of your body.

Gadobutrol injection is also used for magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adults and children. It is also used to assess how well blood flows through your heart (myocardial perfusion) and late gadolinium enhancement in adult patients with coronary artery disease (CAD).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadobutrol injection in children. However, safety and efficacy have not been established in premature infants.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadobutrol injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving gadobutrol.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic disorders, history of or
• Bronchial asthma, history of—Use with caution. May increase your risk for an allergic reaction to this medicine.

• Diabetes or
• Hypertension (high blood pressure) or
• Infection, severe or—Use with caution. May increase risk for kidney problems.

• Kidney disease, severe (recent or long-term)—Should not be used in patients with this condition unless your doctor specifically tells you that it is necessary.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins just before you have an MRI or MRA scan.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress while you are receiving this medicine and during the MRI or MRA scan to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor or nurse right away if you or your child have burning or itching of the skin, deep bone pain in the hips or ribs, joint stiffness, a limited range of motion in the arms and legs, muscle weakness, red or dark patches on the skin of the arms or legs, or skin swelling, hardening, or tightening within the first few days or weeks after you receive this medicine. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have chest pain, cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, and throat, or trouble with breathing after receiving the medicine.

This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin, liver, kidney, spleen) for a long time (several months to years). Talk to your doctor if you have concerns.

This medicine may increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased if you or your child are receiving high doses of gadobutrol.

Tell your doctor right away if you or your child have burning pain, feeling of warmth or coldness, redness or swelling at the injection site.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

confusion

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

feeling of warmth

general feeling of discomfort or illness

hives or welts, itching, or skin rash

loss of consciousness

paleness of the skin

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

seizures

sweating

tightness in the chest

unusual tiredness or weakness

Incidence not known

Bluish color of the fingernails, lips, skin, palms, or nail beds

burning sensation

burning, dry, or itching eyes

chest pain

cough

decreased or uncontrolled urination

deep bone pain

difficulty with swallowing

discharge or excessive tearing

hoarseness

increased sweating

lack or loss of strength

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

muscle stiffness or weakness

no blood pressure or pulse

no breathing

noisy breathing

numbness, tingling, pain, or weakness in the hands or feet

paralysis or severe weakness of the legs

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches

slow or irregular breathing

sneezing

stiff joints or trouble moving

stopping of the heart

swelling of the mouth or throat

uncontrolled bowel movements

uncontrolled movements of the body

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Headache

nausea

Rare

Change in sense of smell

change in taste

dizziness

dry mouth

feeling hot or cold

loss of taste

unusually warm skin

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.