Gadobenate (Intravenous)

Gadobenate is a magnetic resonance imaging (MRI) contrast agent that helps produce clear images of the body during MRI scans. MRI scans are a specific type of diagnostic procedure that uses magnets and computers to create images or "pictures" of certain areas inside the body. Unlike x-rays, MRI scans do not use ionizing radiation. Gadobenate is a gadolinium-based contrast agent (GBCA).

Gadobenate is administered by injection before an MRI scan to assist in identifying issues in the brain, spine, and other areas of your body.

This medicine is to be used only by or under the direct supervision of a doctor.

It is very important for your doctor to monitor the progress of you or your child while receiving this medicine and during the MRI scan. This will help your doctor see if the medicine is working correctly and check for any unwanted effects.

Contact your doctor immediately if you or your child experience burning or itching of the skin, red or dark patches on the skin, skin swelling, hardening, or tightening, joint stiffness, limited movement in the arms and legs, deep pain in the hip bone or ribs, or muscle weakness. These may be signs of a serious condition called nephrogenic systemic fibrosis (NSF).

This medicine can cause a severe allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. Inform 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 is a gadolinium-based contrast agent. Gadolinium may accumulate in the brain, bones, skin, and other organs in patients with normal kidney function. Discuss any concerns with your doctor.

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

This medicine can lead to changes in heart rhythm, including a condition known as QT prolongation. It may alter the way your heart beats and could cause fainting or serious side effects in some patients. Contact your doctor immediately if you or your child show any symptoms of heart rhythm issues, such as a fast, pounding, or irregular heartbeat.

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

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

In deciding to use a diagnostic test, you must weigh the risks against the benefits. This is a choice you and your doctor will make together. Other factors may also affect test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children that would limit the usefulness of gadobenate injection. However, safety and effectiveness have not been established in preterm babies.

Geriatric

Studies conducted so far have not shown any specific problems in the elderly that would limit the usefulness of gadobenate. However, older patients are more likely to have kidney issues related to age, which may require caution and a dose adjustment for patients receiving gadobenate.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while other medicines may be used together even if an interaction might happen. In these cases, your doctor may need to change the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence the use of this diagnostic test. Be sure to tell your doctor if you have any other medical issues, especially:

• Anemia or any blood disorder
• Asthma or allergies, history of
• Heart disease, history of
• Heart rhythm problems (e.g., arrhythmia)
• Severe kidney problems (recent or long-term)
• Liver disease
• Patients who have recently received a GBCA
• History of seizures—Use with caution. May worsen side effects.

• Diabetes
• 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 stronger because the medicine may be removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, you may need medical attention.

Check with your doctor or nurse right away if you experience any of the following side effects:

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 or discomfort
• chills
• confusion
• cough
• coughing that may produce 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 standing up quickly 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
• tightness in the chest
• 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. Your healthcare professional may be able to suggest ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, 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, 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.

In the U.S.

• Multihance

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Ionic Contrast Media

A doctor or other trained health professional will give you 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.