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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Gadoterate Meglumine
Generic Name
Gadoterate Meglumine
Active Ingredient
Gadoterate MeglumineCategory
Other
Variants
7
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Gadoterate Meglumine, you must consult a qualified healthcare professional.
| 376.9 mg/mL | INJECTION | INTRAVENOUS | 65219-080 |
| 376.9 mg/mL | INJECTION | INTRAVENOUS | 65219-088 |
| 376.9 mg/mL | INJECTION | INTRAVENOUS | 70436-123 |
Detailed information about Gadoterate Meglumine
Gadoterate meglumine is a macrocyclic, ionic gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) to visualize lesions with abnormal vascularity in the central nervous system.
The standard recommended dose of gadoterate meglumine for adult patients is 0.1 mmol/kg of body weight. This is equivalent to 0.2 mL/kg of the 0.5 mmol/mL solution. For example, a patient weighing 70 kg (154 lbs) would typically receive a 14 mL injection. The dose is administered as an intravenous bolus injection, usually at a rate of approximately 2 mL per second. Following the injection, the intravenous line is typically flushed with a 0.9% sodium chloride (saline) solution to ensure the entire dose enters the central circulation.
In pediatric patients, including term neonates, the dosage is the same as in adults: 0.1 mmol/kg (0.2 mL/kg) of body weight. Clinical trials have demonstrated that this weight-based dosing provides consistent image enhancement across all age groups. Healthcare providers must exercise precision when calculating doses for small infants to avoid over-administration. Gadoterate meglumine has not been studied in preterm infants.
For patients with mild to moderate renal impairment, no specific dose adjustment is usually required, but the lowest effective dose should be used. However, in patients with severe renal impairment (GFR < 30 mL/min/1.73m²), the risk of Nephrogenic Systemic Fibrosis (NSF) must be carefully weighed against the diagnostic benefit. In many cases, healthcare providers will avoid the use of GBCAs in these patients unless the imaging is essential and no alternative is available.
Because gadoterate meglumine is eliminated exclusively by the kidneys and does not undergo hepatic metabolism, no dosage adjustments are necessary for patients with liver disease or impaired hepatic function.
Clinical studies have not identified significant differences in safety or effectiveness between elderly patients (65 years and older) and younger patients. However, because elderly patients are more likely to have reduced renal function, healthcare providers should screen for kidney disease before administration.
Gadoterate meglumine is administered only by trained healthcare professionals in a clinical setting (such as a hospital or imaging center). You do not 'take' this medication yourself.
Since gadoterate meglumine is a single-dose diagnostic agent administered at the time of your MRI, a 'missed dose' is not possible in the traditional sense. If your MRI appointment is canceled or rescheduled, the timing of the injection will simply be moved to your new appointment time.
Overdose with gadoterate meglumine is extremely rare due to the controlled clinical environment in which it is administered. However, if an excessive dose is given, it may lead to increased pressure on the kidneys. In patients with normal kidney function, the body will naturally eliminate the excess. In patients with severe renal failure, hemodialysis may be used to remove the gadoterate meglumine from the blood. Symptoms of an acute reaction might include severe nausea, vomiting, or skin reactions.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Gadoterate meglumine is generally well-tolerated by most patients. However, like all medications, it can cause side effects. Common reactions reported in clinical trials include:
Gadoterate meglumine is intended for diagnostic use only and must be administered by a qualified healthcare professional. Before receiving this agent, it is vital that you provide a complete medical history, especially regarding kidney function, allergies, and previous reactions to contrast media. While gadoterate meglumine is one of the more stable agents in its class, it is not without risks, particularly for specific vulnerable populations.
Gadoterate meglumine carries a prominent FDA Black Box Warning regarding Nephrogenic Systemic Fibrosis (NSF). This condition is characterized by the formation of excessive connective tissue in the skin and internal organs, leading to severe disability or death. The warning emphasizes that patients with severe renal impairment or acute kidney injury are at the highest risk. Healthcare providers are instructed to screen all patients for renal dysfunction before administering gadoterate meglumine.
There are no specific drugs that are absolutely contraindicated for use with gadoterate meglumine. However, the drug should never be mixed in the same syringe or IV line with other medications, as physical incompatibilities may occur. Each medication should be administered through a separate line or the line should be thoroughly flushed between administrations.
These are conditions where the drug may be used, but only after a careful risk-benefit analysis by the medical team:
Gadoterate meglumine is classified under the older FDA Pregnancy Category C. Data on the use of gadoterate meglumine in pregnant women are limited. Animal studies have shown that gadolinium can cross the placental barrier and may be retained in fetal tissues. There is a theoretical risk that the release of free gadolinium could harm fetal development. The American College of Radiology (ACR) recommends that GBCAs should only be administered to pregnant women when the information requested is essential for the health of the mother or fetus and cannot be obtained via other means. It should not be used for 'routine' screening during pregnancy.
Small amounts of gadoterate meglumine (less than 0.04% of the maternal dose) are excreted into human breast milk. Furthermore, the absorption of gadolinium by the infant's gastrointestinal tract is extremely low (less than 1%). According to the ACR and most clinical guidelines, it is safe to continue breastfeeding after receiving gadoterate meglumine. Mothers who are concerned may choose to 'pump and dump' for 12 to 24 hours, but this is generally considered unnecessary by medical experts.
Gadoterate meglumine is FDA-approved for use in pediatric patients from birth (term neonates) through adolescence. It is one of the few contrast agents with specific safety data for infants under two years of age. In neonates, the kidneys are not yet fully mature, which means the drug may stay in the system longer than in adults. However, clinical trials have shown that the standard dose of 0.1 mmol/kg is safe and effective for this population. It is not approved for use in premature infants.
Gadoterate meglumine is a paramagnetic contrast agent. Its primary mechanism of action involves the gadolinium ion ($Gd^{3+}$), which has seven unpaired electrons. This electronic configuration gives it a high magnetic moment. When the patient is placed in the MRI's magnetic field, gadoterate meglumine shortens the T1 and T2 relaxation times of water protons in the surrounding tissues. The shortening of T1 relaxation increases the signal intensity (brightness) of the tissues where the drug has accumulated. Because it is a macrocyclic agent, the gadolinium is held tightly within the DOTA ligand, preventing the toxic metal from interacting directly with biological molecules while still allowing it to influence the magnetic properties of nearby water.
The diagnostic effect of gadoterate meglumine is immediate upon reaching the target tissue. The 'peak' enhancement for CNS imaging typically occurs within minutes of the bolus injection. The duration of the effect is limited by the rapid redistribution and renal clearance of the drug. It does not have any known effect on the cardiovascular system or other organ systems at the recommended diagnostic doses, other than the rare risk of hypersensitivity.
Common questions about Gadoterate Meglumine
Gadoterate meglumine is a contrast agent used specifically for magnetic resonance imaging (MRI) of the central nervous system. It helps radiologists see the brain, spine, and surrounding tissues more clearly by highlighting areas of inflammation, tumors, or vascular abnormalities. When injected into a vein, it travels through the bloodstream and accumulates in areas where the blood-brain barrier has been damaged. This allows for a more accurate diagnosis of conditions like multiple sclerosis, primary brain cancers, or metastatic tumors. It is approved for use in adults, children, and even newborn infants.
The most common side effects reported by patients receiving gadoterate meglumine include nausea, headache, and reactions at the site of injection. Injection site reactions may feel like coldness, warmth, or mild pain where the needle was inserted. Some patients also report a temporary metallic taste in their mouth or a brief feeling of dizziness immediately following the injection. These symptoms are usually mild and go away on their own within a few minutes to an hour. If you experience more severe symptoms like hives or trouble breathing, you should alert the medical staff immediately.
While there is no direct chemical interaction between alcohol and gadoterate meglumine, it is generally recommended to avoid alcohol for at least 24 hours after your MRI. Alcohol is a diuretic and can lead to dehydration, which may make it harder for your kidneys to process and eliminate the contrast agent. Staying well-hydrated with water is the best way to help your body clear the medication. If you have any history of kidney disease, avoiding alcohol is even more important to protect your renal health. Always follow the specific post-procedure instructions provided by your imaging center.
The safety of gadoterate meglumine during pregnancy has not been fully established, and it is generally used only when the potential benefit outweighs the risk to the fetus. Gadolinium can cross the placenta and stay in the fetal environment for an unknown amount of time. Because of this, the American College of Radiology suggests avoiding gadolinium contrast unless it is absolutely necessary for a critical diagnosis that cannot wait until after delivery. If you are pregnant or think you might be, you must inform your doctor and the MRI technologist before the procedure. They may choose to perform the MRI without contrast or use a different imaging method like ultrasound.
Gadoterate meglumine works almost instantly once it is injected into your vein. Because it is administered as an intravenous bolus, it reaches the heart and then the brain and spine within seconds. The radiologist will typically begin taking the 'contrast-enhanced' images within minutes of the injection to capture the drug at its peak concentration in the target tissues. The enhancement effect lasts long enough for the remainder of the MRI sequence, usually about 20 to 30 minutes. After this time, the drug begins to redistribute and be filtered out by your kidneys.
Gadoterate meglumine is not a daily medication that you 'take' over time; it is a single-dose diagnostic tool administered by a healthcare professional. Therefore, there is no concept of 'stopping' the medication or experiencing withdrawal. Once the injection is given for your MRI, the process is complete. You do not need to worry about tapering off the drug or any long-term dependency. If you have concerns about the drug remaining in your system, drinking plenty of fluids after the procedure will help your kidneys eliminate it more quickly.
Since gadoterate meglumine is only given during a scheduled MRI appointment by a medical professional, you cannot 'miss a dose' in the way you might miss a daily pill. If you miss your MRI appointment, you simply won't receive the medication. If the appointment is rescheduled, the contrast will be administered at that time. There is no need to 'make up' a dose or take any action other than following your healthcare provider's instructions for rescheduling your imaging procedure.
No, gadoterate meglumine does not cause weight gain. It is a single-dose diagnostic agent that is cleared from the body relatively quickly, usually within 24 hours for patients with healthy kidneys. It does not affect your metabolism, appetite, or fat storage. Any weight fluctuations you experience would be unrelated to this contrast agent. If you notice sudden swelling or 'water weight' after the procedure, especially in your legs or face, contact your doctor, as this could be a sign of a rare allergic reaction or kidney issue rather than typical weight gain.
Gadoterate meglumine can generally be used even if you are taking other medications, but you must inform your doctor about everything you take. The main concern is with other drugs that might affect your kidneys, such as certain antibiotics or high-dose anti-inflammatory drugs (NSAIDs). Additionally, if you take beta-blockers for heart health, you might be at a slightly higher risk for an allergic reaction. The contrast agent itself is not mixed with other drugs in the same syringe. Your medical team will review your medication list to ensure the MRI contrast is safe for you.
As of 2024, gadoterate meglumine is primarily available under the brand name Dotarem, but generic versions have begun to enter the market following the expiration of certain patent protections. Generic versions must meet the same strict FDA standards for safety, purity, and effectiveness as the original brand-name product. Whether you receive the brand name or a generic version, the active ingredient and the way it works in your body will be identical. Your hospital or imaging center will determine which specific version they stock based on their current supply contracts.
Other drugs with the same active ingredient (Gadoterate Meglumine)
These effects occur in a smaller percentage of the population and are usually transient:
> Warning: Stop the procedure and call your doctor immediately if you experience any of these.
One of the most discussed long-term considerations is Gadolinium Retention. Research has shown that trace amounts of gadolinium can remain in the brain, bones, and skin for months or even years after an MRI. While macrocyclic agents like gadoterate meglumine are less likely to leave deposits than linear agents, retention still occurs. To date, no specific disease or health problem has been definitively linked to these small deposits in patients with normal kidney function, but the FDA continues to monitor this closely. Patients who require multiple lifetime MRI scans may be at higher risk for accumulation.
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.
Report any unusual symptoms to your healthcare provider.
Before the procedure, your doctor will likely order a blood test to check your estimated Glomerular Filtration Rate (eGFR), which measures how well your kidneys are working. This is especially important if you are over 60, have diabetes, or have high blood pressure. During the injection, your heart rate, blood pressure, and breathing will be monitored by the imaging staff. After the procedure, no routine lab tests are typically required unless you have a known kidney condition.
Gadoterate meglumine does not typically cause sedation or cognitive impairment. Most patients are able to drive and operate machinery immediately after their MRI. However, if you experience dizziness or nausea as a side effect, you should wait until these symptoms pass before driving.
There are no known direct interactions between alcohol and gadoterate meglumine. However, alcohol can cause dehydration, which may put additional stress on the kidneys when they are trying to eliminate the contrast agent. It is generally advisable to avoid alcohol for 24 hours after the procedure and focus on water intake.
As this is a single-use diagnostic agent, there is no 'discontinuation' or tapering process. Once the MRI is complete and the drug is injected, the process is finished. There is no risk of withdrawal syndrome.
> Important: Discuss all your medical conditions with your healthcare provider before starting Gadoterate Meglumine.
There are no known interactions with specific foods, including grapefruit or dairy. However, the primary 'interaction' of concern is hydration status. Patients should be well-hydrated but may be asked to avoid heavy meals immediately before the MRI to minimize the risk of nausea and vomiting during the scan.
While there are no documented interactions with supplements like St. John's Wort or Ginkgo Biloba, any supplement that affects kidney function should be disclosed to the radiologist. Creatine supplements, for example, can artificially elevate serum creatinine levels, which might lead to an inaccurate calculation of your kidney function (eGFR).
Gadoterate meglumine can interfere with certain laboratory tests if the blood is drawn shortly after the MRI:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients who have had a mild reaction to other gadolinium-based contrast agents (such as gadobutrol or gadopentetate dimeglumine) may be at an increased risk for a reaction to gadoterate meglumine. However, because gadoterate meglumine is macrocyclic and ionic, it is sometimes used as an alternative in patients who reacted to 'linear' agents, provided the previous reaction was not severe and appropriate premedication (like corticosteroids and antihistamines) is administered.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Gadoterate Meglumine.
In patients over the age of 65, the primary concern is the natural age-related decline in kidney function. Since gadoterate meglumine is cleared by the kidneys, elderly patients should be screened for renal impairment before administration. There is no evidence that the drug works differently or is less safe in the elderly, provided their kidney function is adequate.
This is the most critical special population for gadoterate meglumine.
No special considerations are required for patients with liver disease. The liver does not play a role in the clearance or metabolism of gadoterate meglumine.
> Important: Special populations require individualized medical assessment.
|---|---|
| Bioavailability | 100% (Intravenous) |
| Protein Binding | < 5% |
| Half-life | 1.4 - 1.6 hours |
| Tmax | Immediate (end of injection) |
| Metabolism | None |
| Excretion | Renal (91% within 24 hours) |
Gadoterate meglumine belongs to the class of Macrocyclic Gadolinium-Based Contrast Agents (GBCAs). It is further sub-classified as an ionic agent. Other drugs in the GBCA class include gadobutrol (Gadavist), gadoteridol (ProHance), and gadobenate dimeglumine (MultiHance). Among these, gadoterate meglumine is noted for its high stability and its approval for use in the youngest pediatric populations.