Pronunciation:

gad-oh-BEN-ate dye-MEG-loo-meen

Brand Names:

• Multihance

Dosage Forms:

• Solution

Warnings:

Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. Gadobenate dimeglumine injection is not approved for intrathecal use. GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of gadobenate dimeglumine in these patients unless the diagnostic information is essential and not available with non-contrasted 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 kidney disease (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 gadobenate dimeglumine dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration

Classifications:

Therapeutic—

Radiological Ionic Contrast Media

Uses of This Medicine:

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

This medicine is to be used only by or under the direct supervision of a 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 gadobenate injection in the pediatric population. However, safety and efficacy have not been established in preterm babies.

Older adults—

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

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 any other blood disorder or
• Asthma or allergies, history of or
• Heart disease, history of or
• Heart rhythm problems (eg, arrhythmia) or
• Kidney problems, severe (recent or long-term) or
• Liver disease or
• Patients who have recently received a GBCA or
• Seizures, history of—Use with caution. May cause side effects to become worse.

• Diabetes or
• Hypertension (high blood pressure)—Use with caution. May increase risk for more serious side effects.

• Dubin-Johnson syndrome (an inherited disorder)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A doctor or other trained health professional will give you 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 the progress of you or your child while you are receiving this medicine and during the MRI scan. This will allow your doctor to see if the medicine is working properly and 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 mental 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 you receive 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.

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

This medicine can cause changes in heart rhythm, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have fainting or irregular heartbeat.

Before you have any medical tests, tell the medical doctor in charge that you or your child are receiving gadobenate. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Anxiety

back pain

black, tarry stools

bladder pain

bloody or cloudy urine

blue lips and fingernails

blurred vision

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

chest pain, discomfort, or tightness

chills

confusion

cough

coughing that sometimes produces a pink frothy sputum

dark urine

decreased urination

deep or fast breathing with dizziness

difficult or labored breathing

difficult, burning, or painful urination

difficult, fast, or noisy breathing

difficulty with breathing or swallowing

dizziness

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

excessive muscle tone

fainting

fast, slow, or irregular heartbeat

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

hives, itching, skin rash

inability to move the legs or arms

increased sweating

lower back or side pain

muscle stiffness, tension, or tightness

nausea

nervousness

numbness of the feet, hands, and around the mouth

pain in the shoulders, arms, jaw, or neck

pain or redness at the injection site

pale skin at the injection site

paralysis of one side of the body

pounding heartbeat

pounding in the ears

problems with speech or speaking

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

reddening of the skin, especially around the ears

seizures

shakiness in the legs, arms, hands, or feet

sore throat

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

sugar in the urine

sweating

swelling in the legs and ankles

swelling of the eyes, face, or inside of the nose

swollen glands

tiredness

trembling or shaking of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Incidence not known

Lack or loss of strength

loss of consciousness

peeling of the skin

skin lesions

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, rash, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

feeling hot

Rare

Bad, unusual, or unpleasant (after) taste

belching

blurred or loss of vision

change in sense of smell

change in taste

continuing ringing or buzzing or other unexplained noise in the ears

decreased awareness or responsiveness

diarrhea

difficulty having a bowel movement

difficulty with moving

disturbed color perception

double vision

dry mouth

ear pain

feeling unusually cold

halos around lights

hearing loss

heartburn

indigestion

joint pain

lack or loss of strength

loss of bowel control

muscle aches, spasms, or cramps

night blindness

overbright appearance of lights

redness of the eye

severe sleepiness

shivering

stomach discomfort or upset

stuffy nose

swollen joints

tunnel vision

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.