Pronunciation:

gad-oh-TER-i-dol

Brand Names:

• Prohance

Dosage Forms:

• Solution

Warnings:

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadoteridol injection is not approved for intrathecal use. GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of gadoteridol injection in these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with: chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended gadoteridol dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration .

Classifications:

Therapeutic—

Radiological Non-Ionic Contrast Media

Uses of This Medicine:

Gadoteridol injection is a magnetic resonance imaging (MRI) contrast agent used to help create a clear picture of the body during an MRI scan. MRI scans use magnets and computers to create images of certain areas of the body. Unlike x-rays, MRI scans do not involve radiation. Gadoteridol is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the brain, spine, head, or neck.

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 gadoteridol injection in newborns to children 17 years of age. Safety and efficacy have been established.

Older adults—

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

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:

• Anemia or
• Asthma or allergies, history of or
• Diabetes or
• Hypertension (high blood pressure) or
• Sickle cell anemia—Use with caution. May increase risk for side effects.

• Kidney problems, severe, or history of or
• Liver disease, history of or
• Seizures (grand mal), history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine. It is given through an IV catheter that is placed into one of your veins just before you have an MRI 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 scan to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine should not be given intrathecally (injection given through the spinal canal). It may cause serious unwanted effects including agitation, back pain, blurred vision, change or loss of consciousness, confusion, death, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or metal changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting when given intrathecally.

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 increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadoteridol.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 breathing after receiving the medicine.

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

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

Absence of or decrease in body movement

arm, back, or jaw pain

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

blurred vision

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

chest pain, discomfort, or tightness

confusion

cough

decreased awareness or responsiveness

difficult or labored breathing

difficulty swallowing

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

false feeling of insects crawling on the skin

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

fever

general feeling of discomfort or illness

headache, severe and throbbing

hives, itching, skin rash

hoarseness

increased salivation

loss of bladder control

loss of consciousness

low blood pressure or pulse

nausea

nervousness

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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

seizures

shakiness in the legs, arms, hands, or feet

slow, fast, or irregular breathing

spasm of the throat

sweating

trembling or shaking of the hands or feet

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

Agitation

burning, dry, or itching eyes

coughing that sometimes produces a pink frothy sputum

decreased or uncontrolled urination

difficult, fast, noisy breathing

discharge, excessive tearing

incoordination

lack or loss of strength

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

muscle weakness

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

paralysis or severe weakness of the legs

slow heartbeat

skin lesions (plaques)

stiffness of the arms or legs

swelling in the legs and ankles

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:

Rare

Anxiety

bad, unusual, or unpleasant (after) taste

bleeding gums

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

continuing ringing or buzzing or other unexplained noise in the ears

diarrhea

dry mouth

ear discomfort

hearing loss

irritation in the mouth

loss of coordination in the arms

mouth ulcers

rash with flat lesions or small raised lesions on the skin

redness and swelling of the gums

runny or stuffy nose

sneezing

stomach cramps

tingling sensation in the throat

voice changes

vomiting

watery eyes

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.