Gadoterate (Intravenous)

Gadoterate injection is used to help diagnose or find problems in the brain, spine, head, neck, 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 different parts of the body during certain medical procedures, like 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.

It is very important that your doctor checks you or your child's progress while you are receiving this medicine and during the MRI scan to ensure 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 experience 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, deep pain 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 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 is more likely in patients with a history of kidney problems or in patients receiving increasing 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, a feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Studies have not shown any specific problems in children from newborns to 17 years of age that would limit the use of gadoterate injection. However, safety and effectiveness have not been established in preterm newborns.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the use of gadoterate injection. However, older patients are more likely to have kidney problems related to aging, which may require caution when using gadoterate.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain 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 certain medicines may also cause interactions. Discuss with your healthcare professional how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, 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
• Severe infection—Use with caution. May increase your risk of kidney problems (e.g., reduced kidney function).

• Mild or moderate kidney disease—Use with caution. May increase the likelihood of serious side effects.

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

Along with its intended effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

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

• Red or dark areas on the skin or tightness in the skin
• bluish color of the fingernails, lips, skin, palms, or nail beds
• bone pain in the hips or ribs
• burning, dry, or itchy eyes
• change in consciousness
• chest pain or discomfort
• cough
• decreased or uncontrolled urination
• difficulty 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 typically do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have suggestions to help prevent or reduce some of these side effects. Talk to your health care professional if any of the following side effects continue, 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 sensations
• 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

• Short-lived, mild, pleasant aromatic smell

Other side effects not listed may also happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clariscan
• Dotarem

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

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.