All About Gadobutrol:
Gadobutrol is a hydrophilic (liquid-loving), gadolinium-based contrast agent that is used in CE-MRI (contrast-enhanced magnetic resonance imaging) for clear images of the body while performing the MRI (magnetic resonance imaging) scan. It is one of the most commonly used contrast agents for the diagnosis of disrupted areas of the BBB (blood-brain barrier) and vascular anomalies of the central nervous system. Gadobutrol is a second-generation macrocyclic contrast agent used in both children and adults during MRI. It is available in the form of a solution that is injected by healthcare professionals while doing MRI scans and magnetic resonance angiography for the diagnosis of various vascular anomalies, coronary artery disease, and disrupted areas of the central nervous system. Gadobutrol was approved by FDA (food and drug organization) on March 24, 2011, as the safest contrast agent for use in both adults and children. Read the article to know more about Gadobutrol usage, indications, contraindications, mechanism of action, and side effects.
How Does Gadobutrol Work?
Gadobutrol works by reducing the T1 and T2 relaxation times (parameters in MRI). Shorter T1 and T2 times enhance the signal. The concentration of the drug and R1 relaxation time result in the T1 shortening effect and enhance the image quality with improved tissue visualization.
Uses of Gadobutrol:
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Magnetic Resonance Imaging (MRI) of the Central Nervous System: To diagnose the areas of the disrupted blood-brain barrier.
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Breast MRI: To evaluate the extent of breast disease in case of malignancy in adult patients.
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Magnetic Resonance Angiography: For evaluation of arterial diseases like renal artery and supra-aortic diseases in children, adults, and neonates. It is also used to assess vascular anomalies.
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MRI of the Heart: To diagnose coronary artery disease.
Doses:
The ideal recommended dose for adult and pediatric patients is 0.1 milliliter per kilogram of body weight. In patients with cardiac diseases, the dose is divided equally into two separate injections.
For Patients
Learn More About Gadobutrol
When and Why Is Gadobutrol Injection Used?
Intravenous injections of Gadobutrol are used during magnetic resonance imaging and magnetic resonance angiography to rule out diseases of the central nervous system, spine, heart, breast, and other body parts. Diseases of arterial occlusion, coronary artery diseases, breast cancer, and renal artery occlusion can be ruled out with high-definition images produced by MRI and by using the contrast agent Gadobutrol.
Things to Inform the Doctor Before They Administer Gadobutrol
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Inform the doctor in case of any systemic diseases like diabetes, asthma, hypertension, blood disorders, or kidney diseases.
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Inform the doctor in case of any previous history of magnetic resonance imaging with any other contrast agents.
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Update the doctor about any kind of allergy to any drug or its composition. Any allergies to dyes, preservatives, contrast agents, and food products should be reported to the doctor.
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Inform the doctor in case of pregnancy or planning to become pregnant.
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Breastfeeding mothers should inform the doctor about their health conditions.
Starting Gadobutrol
How to Administer Gadobutrol?
Gadobutrol is a contrast agent that is administered by healthcare professionals only while performing magnetic resonance imaging and angiography. It is usually administered into the veins (intravenous) very slowly (2 mL per minute should be the rate of administration) under all septic precautions and sterile conditions. The volume of administration depends on the individual’s body weight. It can be used for both adults and children (including neonates).
Things to Do After Gadobutrol Injection:
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Observe any side effects like skin rashes, or swelling on the face or lips. Inform the doctor about the side effects noticed.
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Drugs can cause drowsiness and dizziness after administration, so it is advised not to drive or use heavy machinery after the injection.
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Inform the doctor immediately in case of worsening of the health condition.
Look Out for the Side Effects:
Common Side Effects:
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Allergies like skin rashes, hives, itching, and scratching of the skin.
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Feeling drowsiness or dizziness.
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Lack of mental alertness.
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Chest pain.
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Change in amount of urine.
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Difficulty in urination.
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Burning sensation or pain at the site injection.
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Bitter taste in the mouth.
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Headaches.
In case of any adverse effects noticed after the injection, it is recommended to inform the doctor immediately.
Dietary Alterations
Gadobutrol does not interact with food, so it can be used with or without food.
What Should Be Done in Case of Overdose?
The safe, tolerable dose of Gadobutrol administered is around 1.5 mL per kilogram of body weight. Increased levels of Gadobutrol in the body can be removed by the doctor through hemodialysis.
Storage of Gadobutrol:
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Gadobutrol solution can be stored at room temperature of 15 to 30 degree Celsius.
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Gadobutrol is used at room temperature.
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Avoid using Gadobutrol if the solution is discolored and the container is broken.
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Avoid using expired Gadobutrol solutions.
Avoid Self-Prescription:
Gadobutrol is only used by doctors and is administered by them during diagnostic procedures. It is not available for the patient's use.
For Doctors
Indications:
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While performing magnetic resonance imaging for getting clear images of the affected areas.
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To diagnose any disruption in the central nervous system.
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For the diagnosis of coronary artery disease.
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For the diagnosis of vascular anomalies.
Contraindications:
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The drug Gadobutrol is contraindicated in patients with severe systemic diseases.
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The drug Gadobutrol is not indicated in patients with severe hypersensitivity reactions in the past with any contrast agent or dye.
Pharmacology
Mechanism of Action:
Gadolinium acts by shortening T1 and T2 relaxation times. High signal intensity is received with increased shortening of T1 and T2 times. The T1 and T2 shortening effects increase the clarity of the images and improve tissue visualization.
Ingredients
Active Ingredient: Gadobutrol is the only active agent present.
Inactive Ingredients:
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Calcobutrol sodium.
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Hydrochloric acid.
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Distilled water.
Doses and Forms:
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Gadobutrol is available in the clear, pale yellow, and colorless solution form and is administered by the healthcare professional intravenously (into the veins) during magnetic resonance imaging and angiography. The dose and volume of the drug are determined by body weight.
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Gadobutrol is recommended at a dose of 1.5 mL per kilogram of body weight.
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Gadobutrol is available in the form of prefilled syringes containing 604 mg of Gadobutrol per milliliter.
Absorption:
The average absorption rate of Gadobutrol is around 1.1 millimoles per hour per liter in a person with normal kidney function.
Volume of Distribution:
The average plasma level after administration of 0.1 millimoles per kilograms of body weight of Gadobutrol injection is around 0.59 mmol per liter.
Protein Binding:
The drug Gadobutrol does not bind to any specific protein.
Metabolism:
The drug Gadobutrol does not undergo a metabolic process.
Excretion:
The contrast agent Gadobutrol is excreted unchanged by the kidney through glomerular filtration. A very negligible extrarenal exception is observed.
Half-Life:
The average half-life of Gadobutrol is around 1.8 hours.
Renal Clearance:
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In healthy individuals with normal kidney functioning, the average renal clearance is around 1.1 to 1.7 mL per minute.
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After 2 hours of the administration of the drug, fifty percent of the drug is removed or from the body unexchanged through urine.
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After 12 hours of the injection, almost the entire drug is eliminated or excreted through the urine.
Toxicity:
Mild to severe cardiac, respiratory, and skin manifestations have been reported due to Gadobutrol's toxic dose. A few studies have reported hypersensitivity reactions in case of toxicity. However, toxicity cases with Gadobutrol are very rare.
Warning and Precautions:
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Risk of Nephrogenic Systemic Fibrosis: It is advised to check if the child is having any burning or itching sensation after the administration of the medication Gadobutrol. It is recommended to check for any joints or pain near hips or ribs, stiffness in the joint, and limited movement of the extremities due to weakness of the muscle. As these are red flag symptoms for Nephrogenic Systemic Fibrosis.
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Risk of Acute Kidney Injury: The drug Gadobutrol carries the risk of acute kidney injury (AKI). It is observed in patients with severe kidney problems and people who received an overdose of Gadobutrol.
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Risk of Fall: The drug Gadobutrol can result in increased drowsiness and dizziness among the patients after injections. Precautions should be taken to not operate heavy machinery or drive after the administration of the drug.
Drug Interactions
No data on drug interactions is yet available.
Other Specifications
Gadobutrol in Pregnant and Lactating Women:
Not enough research and controlled trials are yet available to determine the efficacy and safety of the drug Gadobutrol in pregnant and lactating women. However, a few studies show retention of Gadolinium-based contrast agents in the bodies of pregnant females after crossing the placenta, resulting in fetal exposure. With the potential risk, Gadobutrol can be used cautiously in case magnetic resonance imaging needs to be performed in emergencies to avoid delays in diagnosis. The risk of fetal birth defects and miscarriages in pregnant females is rarely reported in the literature after the administration of Gadobutrol. A trace amount of Gadolinium-based contrast agent was reported to be found in the breast milk, which interferes with the absorption of the milk.
Gadobutrol in Pediatric Patients:
The drug Gadobutrol has proven efficacy for use in children, including infants. The drug Gadobutrol can be safely used in the pediatric population for the diagnosis of vascular abnormalities of the central nervous system and disruptions in the blood-brain barrier.
Gadobutrol in Geriatric Patients:
The drug Gadobutrol can be used safely in elderly patients as well. According to the research, Gadobutrol has delayed clearance in elderly populations as compared to the younger population. So it is advisable to use Gadobutrol very cautiously in elderly patients in accurate dosage based on body weight.
Results after Clinical Trials:
Various clinical trials have been done with Gadobutrol to check its effectiveness as a diagnostic tool. A few clinical trials reported are:
Magnetic Resonance Imaging in Breast Malignancy:
A trial was performed on different subjects for breast examination with plain MRI and other subjects with Gadobutrol-induced magnetic resonance imaging. In a few subjects, mammograms were also performed. All the readings obtained from different techniques were evaluated. The results showed superior results in subjects who had undergone Gadobutrol breast MRI to that of other techniques.
Magnetic Resonance Angiography in Vascular Anomalies:
Various clinical trials done to diagnose vascular anomalies in the central nervous system with Gadobutrol induced magnetic resonance angiography. It shows superior results than CTA (computed tomography angiography).
