Pronunciation:

gad-oh-PEN-te-tate dye-MEG-loo-meen

Brand Names:

• Magnevist

Warnings:

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF), in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all 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), perform lab testing to estimate the GFR. Do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Uses of This Medicine:

Gadopentetate 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 diagnostic procedure that use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve radiation. Gadopentetate is a gadolinium-based contrast agent (GBCA).

Gadopentetate is given by injection before MRI to help diagnose problems in the brain, spine, head, neck, tissues, and other parts of your 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 gadopentetate injection in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

No information is available on the relationship of age to the effects of gadopentetate injection in geriatric patients.

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 or allergies, history of or
• Patients who have had prior reactions to contrast media—Use with caution. May increase your risk for having an allergic reaction.

• Diabetes or
• Hypertension (high blood pressure) or
• Infection, severe or—Use with caution. May increase your risk of having kidney problems (eg, reduced kidney function).

• Kidney disease, mild or moderate—Use with caution. May increase the likelihood of serious side effects.

• Kidney disease, severe (acute 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. It is given through a needle 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.

The risk of having a serious disease called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that it is still important to receive this medicine. Check with your doctor right away if you or your child have burning or itching of the skin, red or dark patches on the skin, swelling, hardening, or tightening of the skin, joint stiffness, limited range of motion in the arms and legs, pain that is deep in the hip bone or ribs, or muscle weakness. These may be symptoms of 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 cold, clammy skin, confusion, dizziness, lightheadedness, a skin rash, itching, sweating, swelling of the face, tongue, or throat, trouble with breathing, or chest pain after you receive 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 kidney failure. This is more likely if you or your child are receiving high doses of gadopentetate injection.

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

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

changes in skin color

chest pain, discomfort, tightness, or heaviness

chills

confusion

cough

difficult or labored breathing

difficulty with swallowing

dizziness

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

fainting

fast, pounding, or irregular heartbeat or pulse

fever

headache, severe and throbbing

hives, itching, skin rash

irritation of the throat

loss of bladder control

loss of consciousness

nausea

nervousness

noisy breathing

pain or swelling of the treated skin

paleness of the skin

pounding in the ears

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

red or irritated eyes

redness, tenderness, itching, burning, or peeling of the skin

runny nose

seizures

slow heartbeat

sneezing

sore throat

stuffy nose

sweating

swelling of the foot or leg

swelling or puffiness of the face

tenderness

total body jerking

unusual tiredness or weakness

Incidence not known

Agitation

blistering, peeling, or loosening of the skin

burning or itching of the skin

coughing that sometimes produces a pink frothy sputum

decreased urine output

depression

diarrhea

difficulty with speaking

frequent strong or increased urge to urinate

hoarseness

hostility

increased sweating

irritability

joint or muscle pain

joint stiffness

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

limited range of motion in the arms and legs

muscle twitching or weakness

no blood pressure or pulse

no breathing

pain that is deep in the hip bone or ribs

pain, redness, or swelling in the arm or leg

rapid weight gain

red or dark patches on the skin

shakiness in the legs, arms, hands, or feet

skin swelling, hardening, or tightening

slow or irregular breathing

sores, ulcers, or white spots in the mouth or on the lips

spots on your skin resembling a blister or pimple

stopping of the heart

swelling of the face, ankles, or hands

tenderness

tightness in the chest

trembling or shaking of the hands or feet

troubled breathing

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

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

Rare

Bad, unusual, or unpleasant (after) taste

burning, dry, or itching eyes

change in taste

continuing ringing or buzzing or other unexplained noise in the ears

decrease or change in vision

difficulty having a bowel movement

discharge or excessive tearing

double vision

dry mouth

ear pain

eye pain

feeling cold or warm

hearing loss

hyperventilation

increased salivation

lack or loss of strength

loss of appetite

nervousness

pain in the tooth

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

restlessness

seeing double

sleepiness or unusual drowsiness

stomach pain or discomfort

tearing of the eyes

thirst

trouble sleeping

uncontrolled eye movements

vomiting

weight loss

Incidence not known

Blurred or loss of vision

change in sense of smell

difficulty with moving

disturbed color perception

double vision

halos around lights

night blindness

overbright appearance of lights

poor hearing

tunnel vision

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.