Pronunciation:

gad-oh-ver-SET-a-mide

Warnings:

Patients with impaired renal function receiving gadolinium-based contrast agents have an increased risk of nephrogenic systemic fibrosis, which may result in fatal or debilitating fibrosis of the internal organs, skin, or muscles. Avoid use in this population unless required diagnostic information is not attainable with noncontrasted imaging. Screen patients for conditions that may affect renal function prior to administration and measure GFR if present. Do not use in patients with chronic (GFR less than 30 mL/min) or acute kidney injury, do not exceed the recommended dose, and allow time for the contrast to be removed from the body before readministration .

Uses of This Medicine:

Gadoversetamide injection is used to help diagnose or find problems in the brain, spine, head, neck, liver, and other parts of your body. It is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) scans. Contrast agents are used to help create a clear picture of the different parts of the body during certain medical procedures, such as MRI scans. MRI scans use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation.

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 have not been performed on the relationship of age to the effects of gadoversetamide injection in the pediatric population. However, pediatric patients with serious kidney problems may require caution in patients receiving this medicine. Safety and efficacy have not been established.

Older adults—

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

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 the likelihood of an allergic reaction.

• Diabetes or
• Hypertension (high blood pressure) or
• Infection, severe—Use with caution. May increase your likelihood 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 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 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 very 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, itching, swelling, hardening, or tightening of the skin, red or dark patches on 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 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 using this 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 is more likely in patients with a history of kidney problems or in patients receiving increasing doses of gadoversetamide injection. Talk to your doctor about this risk.

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

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:

More common

Feeling faint, dizzy, or lightheaded

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

headache

sweating

Rare

Blurred vision

changes in skin color, pain, tenderness, or swelling of the foot or leg

chest pain

confusion

constipation

cough

decrease in the amount of urine

depression

difficulty in moving

difficulty swallowing

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

dry mouth

fast, slow, irregular, pounding, or racing heartbeat or pulse

fever

general feeling of discomfort or illness

hives, itching, skin rash

inability to move the eyes

incoherent speech

increased blinking or spasms of the eyelid

increased urination

joint pain or swelling

leg cramp

loss of appetite

metallic taste

muscle ache, pain, cramp, or stiffness

muscle weakness

nausea

neck pain or stiffness

nervousness

paleness of the skin

pelvic pain

pounding in the ears

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

sticking out of the tongue

stomach pain

thirst

tightness in the chest

trouble in breathing, speaking, or swallowing

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

unusual tiredness or weakness

vomiting

weight loss

Incidence not known

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

difficulty or noisy breathing

incoordination

muscle weakness

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

paralysis or severe weakness of the legs

seizures

stiffness of the arms or legs

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:

More common

Bad unusual or unpleasant (after) taste

bleeding, blistering, burning, coldness, discoloration of 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

change in taste

Less Common

Back pain

diarrhea

lack or loss of strength

nausea

runny nose

sneezing

stomach pain

stuffy nose

Rare

Anxiety

confusion

constipation

continuing ringing or buzzing or other unexplained noise in the ears

double vision

feeling of constant movement of self or surroundings

hearing loss

increased salivation

seeing double

sensation of spinning

voice changes

weight loss

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.