Pronunciation:

gad-oh-PIK-len-ol

Brand Names:

• Elucirem

Dosage Forms:

• Solution

Warnings:

Warning: Nephrogenic Systemic Fibrosis (NSF)Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs 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 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, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.For patients at highest risk for NSF, do not exceed the recommended gadopiclenol dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration .

Classifications:

Therapeutic—

Diagnostic Agent

Uses of This Medicine:

Gadopiclenol injection is a magnetic resonance imaging (MRI) contrast agent used to help create a clear picture of the body during an MRI scan. MRI scans use magnets and computers to create images or “pictures” of certain areas of the body. Unlike x-rays, MRI scans do not involve radiation. Gadopiclenol is a gadolinium-based contrast agent (GBCA) that is given by injection before an MRI to help diagnose problems in the brain, spine, head, neck, chest, stomach, hip area, muscle, bone, and other parts of the 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 have not been performed on the relationship of age to the effects of gadopiclenol injection in children younger than 2 years of age. 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 gadopiclenol injection in the elderly. However, elderly patients are more likely to have age-related kidney disease which may require caution in patients receiving this medicine.

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, history of or
• Kidney problems, severe, or history of or
• Liver disease, severe—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.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in 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 your 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.

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 serious allergic reaction, which can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have difficulty in swallowing, fast heartbeat, skin itching, rash, or redness, swelling of the face, throat, or tongue, or trouble breathing after receiving 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.

This medicine may increase your risk of having acute kidney injury (AKI). This has occurred in patients with severe kidney problems, and the risk is increased with high doses of gadopiclenol.

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

Make sure your doctor knows that you have used this medicine. This medicine may affect the results of certain medical tests.

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

Blistering, burning, crusting, dryness, or flaking of the skin

bloody urine

decreased frequency or amount of urine

increased blood pressure

increased thirst

itching, scaling, severe redness, soreness, or swelling of the skin

loss of appetite

lower back or side pain

nausea

swelling of the face, fingers, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

weight gain

Incidence not known

Agitation

burning or itching of the skin

coma

confusion

decreased urine output

deep bone pain in the hips or ribs

depression

difficulty in swallowing

dizziness

headache

hostility

irritability

joint stiffness

lethargy

limited range of motion in the arms and legs

muscle twitching or weakness

red or dark patches on the skin of the arms or legs

seizures

skin swelling, hardening, or tightening

stupor

swelling of the face, throat, tongue, ankles, or hands

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:

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 feelings

change in taste

loss of taste

rash with flat lesions or small raised lesions on the skin

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.