Pronunciation:

gad-oh-TER-ate MEG-loo-meen

Brand Names:

• Clariscan
• Dotarem

Dosage Forms:

• Solution

Warnings:

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadoterate Meglumine 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 gadoterate meglumine in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73m(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, older than 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing .

Classifications:

Therapeutic—

Diagnostic Agent, Radiopharmaceutical Imaging

Uses of This Medicine:

Gadoterate injection is used 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. Gadoterate is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the brain, spine, head, neck, and other parts of the body.

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 gadoterate injection in newborns to children 17 years of age. However, safety and efficacy have not been established in preterm newborns.

Older adults—

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

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:

• Asthma, history of or
• Patients who have had prior reactions to contrast media—Use with caution. May increase the likelihood of an allergic reaction.

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

• Kidney disease, mild or moderate—Use with caution. May increase the risk for more serious side effects.

• Kidney problems, severe (acute or long-term)—Should not be used in patients with this condition.

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 you 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 cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin) 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 requiring dialysis. This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadoterate injection. Talk to your doctor about this risk.

Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, 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

Blurred vision

dizziness

fast, irregular, pounding, or racing heartbeat or pulse

headache

nervousness

pounding in the ears

slow or fast heartbeat

Incidence not known

Areas of the skin that turned red or dark or feel tight

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

bone pain in the hips or ribs

burning, dry, or itching eyes

change in consciousness

chest pain or discomfort

cough

decreased or uncontrolled urination

difficulty with swallowing

discharge or excessive tearing

fainting

fever

hives or welts, itching, skin rash

increased sweating

lack or loss of strength

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

lightheadedness, dizziness, or fainting

loss of consciousness

muscle weakness

no blood pressure or pulse

no breathing

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

paralysis or severe weakness of the legs

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

redness of the skin

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

shakiness in the legs, arms, hands, or feet

skin that burns or itches, swells, scales, or hardens

stiff joints or muscles

stopping of the heart

trembling or shaking of the hands or feet

trouble moving your arms or legs

uncontrolled bowel movements

uncontrolled movements of the body

unusual tiredness or weakness

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

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

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

change in taste

discomfort in the throat

fear

loss of taste

nausea

pain in the arms or legs

sleepiness or unusual drowsiness

vomiting

Incidence not known

Transient, mild, pleasant aromatic odor

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.