Gadoversetamide (Intravenous)

Gadoversetamide injection is used to help diagnose or find issues 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 image of 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 specific 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 for your doctor to monitor you or your child's progress while receiving this medicine and during the MRI scan to ensure it is working properly. Blood and urine tests may be needed to check for side effects.

The risk of a very serious disease called nephrogenic systemic fibrosis (NSF) is higher in patients with severe kidney disease. Even if you have severe kidney issues, your doctor may still decide it is important for you to receive this medicine. Contact your doctor immediately 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 movement in the arms and legs, deep pain in the hip bone or ribs, or muscle weakness. These may be signs of NSF.

This medicine may cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and needs immediate medical help. Inform your doctor right away if you have a rash, itching, hoarseness, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine contains a metal called gadolinium, which can remain in your body (including the brain, bones, and skin) for a long time (several months to years). Discuss any concerns with your doctor.

This medicine may increase your risk of having acute kidney injury that requires dialysis. This is more likely in patients with a history of kidney problems or in patients receiving higher doses of gadoversetamide injection. Talk to your doctor about this risk.

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

In deciding to use a medicine, you and your doctor need to consider the risks versus the benefits. For this medicine, please think about the following:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of gadoversetamide injection in children. However, children with serious kidney problems may need to be cautious when receiving this medicine. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown geriatric-specific problems that would limit the use of gadoversetamide injection in older adults. However, older patients are more likely to have age-related kidney issues, which may require caution when using gadoversetamide.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor might adjust 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 mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may influence the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Asthma or allergies, history of or
• Patients who have had previous 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 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.

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.