Vueway: Uses, Dosage & Side Effects
A next-generation macrocyclic gadolinium-based MRI contrast agent with high relaxivity for enhanced diagnostic imaging in adults and children aged 2 years and older
Vueway (gadopiclenol) is a prescription gadolinium-based contrast agent (GBCA) used to enhance the quality of magnetic resonance imaging (MRI) scans. It belongs to the macrocyclic class of GBCAs and features approximately twice the T1 relaxivity of conventional gadolinium contrast agents, allowing effective diagnostic imaging at half the standard gadolinium dose (0.05 mmol/kg versus 0.1 mmol/kg). Vueway is administered as an intravenous injection by healthcare professionals during MRI examinations to improve visualization and delineation of abnormal structures or lesions throughout the body and brain. It is approved for use in adults and children aged 2 years and older. Clinical trials have demonstrated that Vueway provides equivalent or superior image quality compared to conventional GBCAs while delivering significantly less gadolinium per examination.
Quick Facts: Vueway
Key Takeaways
- Vueway (gadopiclenol) is a macrocyclic gadolinium-based contrast agent with approximately twice the T1 relaxivity of conventional GBCAs, enabling high-quality MRI at half the standard gadolinium dose (0.05 mmol/kg body weight).
- It is approved for use in adults and children aged 2 years and older, with the same weight-based dosing across all age groups (0.1 mL/kg body weight).
- Vueway is administered intravenously by healthcare professionals and patients are monitored for at least 30 minutes after injection for potential allergic reactions.
- The most common side effects are injection site reactions and headache; serious allergic reactions are uncommon but can occur, and no cases of nephrogenic systemic fibrosis (NSF) have been reported in clinical trials.
- Vueway has a macrocyclic chemical structure that provides high kinetic and thermodynamic stability, reducing the risk of gadolinium release in the body compared to linear GBCAs.
What Is Vueway and What Is It Used For?
Vueway contains the active substance gadopiclenol, a macrocyclic gadolinium chelate designed specifically for use as a contrast medium in magnetic resonance imaging (MRI). MRI is a diagnostic imaging technique that uses powerful magnetic fields and radiofrequency pulses to create detailed cross-sectional images of the body’s internal structures. While MRI can produce excellent images without contrast agents, certain clinical situations require enhanced imaging to detect, characterize, and delineate lesions or abnormalities that may not be visible on unenhanced scans.
Gadolinium-based contrast agents (GBCAs) work by shortening the T1 relaxation time of water protons in surrounding tissues. When gadolinium is present in a tissue, the hydrogen nuclei in nearby water molecules return to their equilibrium state more quickly after being excited by the MRI scanner’s radiofrequency pulse. This results in increased signal intensity on T1-weighted MRI sequences, making areas where the contrast agent has accumulated appear brighter on the images. This enhancement is particularly useful for visualizing areas where the blood–brain barrier has been disrupted (such as brain tumors, infections, or inflammatory conditions), regions with abnormal vascularity, and lesions throughout the body including the spine, liver, kidneys, and musculoskeletal system.
What distinguishes Vueway from conventional gadolinium-based contrast agents is its exceptionally high T1 relaxivity. Relaxivity is a measure of how effectively a contrast agent enhances the MRI signal per unit concentration of gadolinium. Gadopiclenol has an r1 relaxivity of approximately 12.8 mM−1s−1 at 1.5 Tesla and 37°C in human plasma, which is roughly twice that of conventional extracellular GBCAs such as gadobutrol (r1 ≈ 5.2), gadoterate meglumine (r1 ≈ 3.6), and gadopentetate dimeglumine (r1 ≈ 4.1). This high relaxivity is achieved through a unique molecular design that features two water molecules coordinated in the inner sphere of the gadolinium complex, compared to the single inner-sphere water molecule found in most other GBCAs.
The practical consequence of this high relaxivity is that Vueway can produce equivalent or superior contrast enhancement at a lower dose of gadolinium. The recommended dose of Vueway is 0.05 mmol/kg body weight, which is half the standard dose used for most conventional GBCAs (0.1 mmol/kg). This dose reduction translates directly to a lower total gadolinium burden per examination, which is a significant clinical advantage given growing awareness about gadolinium retention in body tissues, including the brain, bones, and skin, even in patients with normal kidney function.
Vueway was evaluated in three pivotal phase III clinical trials that compared its diagnostic performance to that of gadobutrol (Gadovist/Gadavist), a widely used macrocyclic GBCA. These trials enrolled over 1,300 patients across multiple indications including central nervous system (CNS) lesions, body/extremity lesions, and combined neurological and body imaging. The primary endpoints assessed non-inferiority of Vueway in terms of lesion visualization, border delineation, and internal morphology as evaluated by independent blinded readers. In all three trials, Vueway at 0.05 mmol/kg demonstrated non-inferiority to gadobutrol at 0.1 mmol/kg across all key imaging parameters, confirming that the half-dose of gadopiclenol provides diagnostic image quality equivalent to the full dose of conventional agents.
Vueway received its first regulatory approval from the U.S. Food and Drug Administration (FDA) in September 2022, followed by approval from the European Medicines Agency (EMA) in 2023. It is approved for use in adults and children aged 2 years and older for contrast-enhanced MRI of the central nervous system and all body regions. Vueway represents a meaningful advancement in contrast-enhanced MRI by maintaining high diagnostic quality while reducing gadolinium exposure.
Gadopiclenol’s high relaxivity means that each gadolinium atom in Vueway produces approximately twice the signal enhancement compared to conventional agents. This allows diagnostic-quality MRI at half the gadolinium dose (0.05 vs. 0.1 mmol/kg), reducing total gadolinium exposure per examination. This is particularly relevant for patients who require frequent or repeated contrast-enhanced MRI examinations, such as those with multiple sclerosis, brain tumors under surveillance, or chronic inflammatory conditions.
What Should You Know Before Receiving Vueway?
Contraindications
The only absolute contraindication to Vueway is known hypersensitivity (allergy) to gadopiclenol or to any of the excipients in the formulation. The excipients in Vueway include tetraxetan, trometamol (tromethamine), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections. If you have a documented allergy to any of these substances, Vueway must not be administered.
While not an absolute contraindication, Vueway is not recommended for patients with severe renal impairment (glomerular filtration rate [GFR] below 30 mL/min/1.73m²) due to the theoretical risk of nephrogenic systemic fibrosis (NSF). NSF is a serious and potentially debilitating fibrosing condition that has been associated with exposure to gadolinium-based contrast agents, particularly linear (non-macrocyclic) agents, in patients with severely impaired kidney function. While no cases of NSF have been reported with gadopiclenol in clinical trials, the general precautionary measures applicable to all GBCAs apply.
Warnings and Precautions
Seek immediate medical attention if you experience signs of a serious allergic reaction after receiving Vueway, including swelling of the face, lips, tongue, or throat, difficulty breathing, skin rash, or dizziness. Most reactions occur within 30 minutes of injection, but delayed reactions can occur hours or even days later.
Before receiving Vueway, inform your doctor or radiologist about the following:
- Previous contrast media reactions: If you have ever had a reaction to any contrast agent (gadolinium-based or iodinated), you may be at increased risk for a reaction to Vueway. Your doctor may administer premedication (such as corticosteroids or antihistamines) and will monitor you more closely.
- Asthma: Patients with asthma may be at higher risk for bronchospasm during or after contrast agent administration. Ensure your asthma is well controlled before the procedure and inform your radiologist about your condition.
- History of allergies: If you have a history of allergic conditions such as hay fever (allergic rhinitis) or urticaria (hives), you may be at slightly increased risk for a hypersensitivity reaction. Your doctor will take appropriate precautions.
- Kidney (renal) impairment: Vueway is primarily eliminated through the kidneys. Impaired kidney function can delay clearance of the contrast agent from your body, potentially increasing gadolinium exposure. Your doctor may order a blood test (serum creatinine or estimated GFR) to assess your kidney function before administration, especially if you are 65 years of age or older.
- Seizure disorders or epilepsy: If you have a history of seizures or are being treated for epilepsy, inform your doctor before receiving Vueway. Gadolinium-based contrast agents have been associated with a very small risk of seizures in susceptible individuals.
- Cardiovascular disease: If you have a disease affecting your heart or blood vessels, your doctor should be informed, as hypersensitivity reactions to contrast media can affect cardiovascular function.
Your doctor or radiologist may decide to perform a blood test to check your kidney function before deciding to use Vueway, particularly if you are 65 years of age or older. This is a standard precaution for all gadolinium-based contrast agents and helps ensure that the contrast agent can be safely eliminated from your body.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor or radiologist before receiving Vueway. Gadopiclenol can cross the placenta, and its effects on the developing fetus have not been fully characterized in humans. As a precaution, Vueway should not be used during pregnancy unless the clinical situation makes it absolutely necessary and the potential benefit to the mother justifies the potential risk to the fetus. In such cases, the minimum effective dose should be used.
If you are breastfeeding or planning to start breastfeeding, discuss this with your doctor or radiologist. It is not fully known to what extent gadopiclenol is excreted in human breast milk. As a precautionary measure, your doctor may recommend that you interrupt breastfeeding for 24 hours after receiving Vueway and discard the milk produced during that period. However, given the very small amounts of contrast agent typically excreted in breast milk and the minimal absorption of gadolinium compounds from the infant’s gastrointestinal tract, some medical societies consider it safe to continue breastfeeding after receiving macrocyclic GBCAs. The decision should be made jointly between you and your healthcare provider.
Drug Interactions
Inform your doctor, radiologist, or pharmacist about all medications you are currently taking, have recently taken, or might take. In particular, inform them if you are taking medications for cardiovascular or blood pressure conditions, including:
- Beta-blockers (such as atenolol, metoprolol, propranolol): Beta-blockers can mask the signs and symptoms of anaphylaxis and may reduce the effectiveness of epinephrine (adrenaline) used to treat severe allergic reactions. If you are taking a beta-blocker and experience a hypersensitivity reaction to Vueway, the reaction may be more difficult to recognize and treat.
- Vasoactive substances: Medications that affect blood vessel tone may interact with the cardiovascular effects of contrast media reactions.
- ACE inhibitors (such as enalapril, ramipril, lisinopril): Angiotensin-converting enzyme inhibitors have been associated with a potentially increased risk of late-onset anaphylactoid reactions to contrast media.
- Angiotensin II receptor antagonists (such as losartan, valsartan, candesartan): Similar to ACE inhibitors, these medications may influence the body’s response to contrast media.
No formal pharmacokinetic drug interaction studies have been conducted with gadopiclenol. As gadopiclenol does not undergo hepatic metabolism and is eliminated primarily through renal excretion in unchanged form, clinically significant pharmacokinetic interactions with other medications are not expected. However, the clinical interactions described above relate to pharmacodynamic effects (i.e., how the body responds to allergic or adverse reactions) rather than how the drug is metabolized.
Driving and Operating Machinery
Vueway has no or negligible direct effect on the ability to drive or operate machinery. However, if you feel unwell after your MRI examination (for example, if you experience dizziness, nausea, or visual disturbances), you should not drive or operate machinery until you have fully recovered.
Sodium Content
Vueway contains less than 1 mmol (23 mg) of sodium per 15 mL vial, making it essentially sodium-free. This is relevant for patients who are on a controlled sodium diet.
How Does Vueway Interact with Other Drugs?
Unlike many traditional oral medications, gadopiclenol does not undergo hepatic (liver) metabolism and is not a substrate, inhibitor, or inducer of cytochrome P450 (CYP) enzymes or drug transporters. It is eliminated almost entirely through renal (kidney) excretion in unchanged form, with an elimination half-life of approximately 1.7 hours in patients with normal kidney function. This pharmacokinetic profile means that gadopiclenol is unlikely to have traditional drug-drug interactions that alter blood levels of either Vueway or concomitant medications.
However, there are important pharmacodynamic interactions to be aware of. These relate not to how the drug is processed by the body, but to how the body responds to potential adverse reactions to the contrast agent. The medications listed in the table below are of particular clinical relevance:
| Drug Category | Examples | Clinical Significance |
|---|---|---|
| Beta-blockers | Atenolol, metoprolol, propranolol, bisoprolol | May mask anaphylaxis symptoms; reduce epinephrine effectiveness in treating allergic reactions |
| ACE Inhibitors | Enalapril, ramipril, lisinopril, perindopril | Potentially increased risk of late-onset anaphylactoid reactions |
| Angiotensin II Receptor Blockers | Losartan, valsartan, candesartan, irbesartan | May influence hemodynamic response to contrast reactions |
| Vasoactive Substances | Nitrates, calcium channel blockers, alpha-blockers | May affect cardiovascular response during adverse reactions |
| Nephrotoxic Drugs | NSAIDs, aminoglycosides, cisplatin, cyclosporine | May impair renal function and delay gadolinium clearance |
| Metformin | Metformin, metformin combinations | No direct interaction; but concurrent renal impairment assessment may be relevant |
It is essential to inform your doctor, radiologist, or MRI technologist about all medications you are taking before receiving Vueway. This includes prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. While Vueway itself does not alter the levels or effects of other drugs, your healthcare team needs this information to prepare for the safe management of any potential adverse reactions and to assess your overall risk profile.
Patients taking beta-blockers deserve particular attention. Beta-adrenergic blockade can diminish the typical signs and symptoms of anaphylaxis (such as tachycardia), making recognition of a serious allergic reaction more difficult. Furthermore, beta-blockers can reduce the efficacy of epinephrine, the first-line treatment for anaphylaxis. Radiologists and MRI staff are trained to manage these situations, but awareness of beta-blocker use helps them prepare appropriate alternative rescue medications (such as glucagon) if needed.
You do not need to stop any of your regular medications before receiving Vueway unless specifically instructed by your doctor. The interactions described above relate to how allergic reactions are managed, not to the contrast agent’s effectiveness. Always bring a current list of your medications to your MRI appointment so the radiology team can provide the safest possible care.
What Is the Correct Dosage of Vueway?
Vueway is administered exclusively by healthcare professionals with experience in clinical MRI practice. It is not a medication that patients self-administer. The contrast agent is injected intravenously (into a vein) through a small needle or intravenous cannula, either manually (by hand) or using an automated power injector. Your doctor or radiologist will determine whether Vueway is appropriate for your examination and will calculate the correct dose based on your body weight.
Adults
The recommended dose of Vueway for adults is 0.1 mL per kilogram of body weight, which corresponds to 0.05 mmol/kg of gadopiclenol. This is half the standard gadolinium dose (0.1 mmol/kg) used for most other gadolinium-based contrast agents, reflecting Vueway’s high relaxivity that enables equivalent image quality at a reduced dose.
| Body Weight | Volume of Vueway | Gadopiclenol Dose | Gadolinium Content |
|---|---|---|---|
| 50 kg | 5.0 mL | 2.5 mmol | 393 mg |
| 60 kg | 6.0 mL | 3.0 mmol | 472 mg |
| 70 kg | 7.0 mL | 3.5 mmol | 550 mg |
| 80 kg | 8.0 mL | 4.0 mmol | 629 mg |
| 100 kg | 10.0 mL | 5.0 mmol | 786 mg |
Vueway is typically administered as a bolus injection at a rate appropriate for the type of MRI examination being performed. For most body and CNS examinations, a flow rate of 1–2 mL per second is commonly used, followed by a saline flush. The timing of the MRI acquisition relative to the injection depends on the specific clinical indication and the MRI protocol being used. Your radiologist and MRI technologist will coordinate the injection timing with the imaging sequence to ensure optimal contrast enhancement.
Children (Aged 2 Years and Older)
The recommended dose of Vueway for children aged 2 years and older is the same as for adults: 0.1 mL/kg body weight (0.05 mmol/kg). In pediatric patients, healthcare professionals should use vials with a syringe (rather than pre-filled syringes or automated injectors) to achieve more precise measurement and administration of the required volume. Accurate dosing is especially important in younger and smaller children, where even small volume differences can result in meaningful dose variations.
The safety and efficacy of Vueway have not been established in children under 2 years of age, and it is not recommended for use in this age group.
Elderly Patients
No dose adjustment is required for elderly patients (65 years of age and older). However, your doctor may order a blood test to assess your kidney function before administration, as kidney function tends to decline with age. If your kidney function is found to be significantly impaired, your doctor will determine whether Vueway is appropriate for you and may consider alternative imaging strategies.
Patients with Kidney Problems
Vueway is not recommended for use in patients with severe renal impairment (GFR < 30 mL/min/1.73m²). However, if the clinical need is compelling and no suitable alternative is available, a single dose of Vueway may be administered. In such cases, a second injection should not be given for at least 7 days to allow adequate time for elimination. In patients with moderate renal impairment, Vueway can generally be used with standard precautions, but kidney function should be assessed before administration.
Overdose
Overdose with Vueway is highly unlikely because it is administered by trained healthcare professionals in a controlled clinical setting. In the unlikely event that an overdose occurs, your doctor will monitor your vital signs and clinical status closely. Gadopiclenol can be removed from the body through hemodialysis (dialysis) if necessary. There is no specific antidote for gadopiclenol overdose, and treatment is supportive.
Post-Injection Observation
After receiving Vueway, you will be kept under observation for at least 30 minutes. This is the period during which most adverse reactions, particularly allergic reactions, are most likely to occur. In rare cases, reactions can occur several hours or even days after injection. If you experience any unusual symptoms after leaving the imaging facility (such as skin rash, swelling, difficulty breathing, or severe headache), seek medical attention immediately and inform the treating physician that you received a gadolinium-based contrast agent.
What Are the Side Effects of Vueway?
Like all medicines, Vueway can cause side effects, although not everyone who receives it will experience them. After administration of Vueway, you will be kept under observation by healthcare professionals. Most side effects occur within minutes of injection, although some reactions can occur up to seven days later. It is important to report any unusual symptoms to your doctor or radiologist immediately.
There is a small risk of allergic reactions to Vueway. Such reactions can range from mild (skin rash, hives) to severe (anaphylaxis, which is a life-threatening emergency). If you experience swelling of the face, lips, tongue, or throat, difficulty breathing, dizziness (low blood pressure), skin rash, coughing, sneezing, or runny nose after receiving Vueway, inform your healthcare provider immediately, as these may be the first signs of a serious allergic reaction.
The following side effects have been observed during clinical trials with Vueway:
Common
May affect up to 1 in 10 people
- Injection site reactions (pain, swelling, feeling cold or warm, bruising, or redness at the injection site)
- Headache
Uncommon
May affect up to 1 in 100 people
- Allergic reactions (skin inflammation, skin redness, difficulty breathing, voice changes, throat tightness, throat irritation, abnormal sensation in the mouth, transient facial flushing, swollen eyes, swelling, rash, itching)
- Diarrhea
- Nausea (feeling sick)
- Fatigue (tiredness)
- Abdominal pain (stomach pain)
- Dysgeusia (unusual taste in the mouth)
- Feeling of warmth
- Vomiting
Reported with Other GBCAs
Potential class-effect risks
- Nephrogenic systemic fibrosis (NSF) – hardening of the skin that can also affect soft tissue and internal organs, reported with other gadolinium-containing contrast agents. No cases of NSF have been reported with Vueway in clinical trials.
- Gadolinium retention – small amounts of gadolinium may be retained in the body (including the brain) after GBCA administration. The clinical significance of this retention is currently unknown. Macrocyclic agents like Vueway show lower retention than linear agents.
Injection site reactions are the most frequently reported adverse events with Vueway. These reactions are generally mild and transient, resolving spontaneously within hours to a few days without requiring specific treatment. They include pain at the injection site, local swelling, a feeling of warmth or cold at the injection site, bruising, and redness.
Allergic (hypersensitivity) reactions to Vueway can manifest in various ways. Early-onset reactions (occurring within minutes to hours) may include skin inflammation, redness, difficulty breathing, voice changes, throat tightness, throat irritation, and transient facial flushing. Late-onset reactions (occurring hours to days after injection) may include swollen eyes, generalized swelling, rash, and itching. Most allergic reactions observed in clinical trials were mild to moderate in severity. However, severe allergic reactions, including anaphylaxis, are possible with any gadolinium-based contrast agent and can be life-threatening if not treated promptly.
Nephrogenic systemic fibrosis (NSF) is a serious condition that has been associated with other gadolinium-based contrast agents, particularly linear (non-macrocyclic) agents, in patients with severely impaired kidney function. NSF causes thickening and hardening of the skin and can also affect connective tissues and internal organs. No cases of NSF have been reported with Vueway during clinical trials. Nevertheless, the precautionary measures recommended for all GBCAs apply, and Vueway is not recommended for patients with severe renal impairment.
Regarding gadolinium retention, studies have shown that small amounts of gadolinium can remain in the body for months to years after GBCA administration, including in the brain (particularly the dentate nucleus and globus pallidus), bones, liver, and skin. This phenomenon occurs with all GBCAs, but macrocyclic agents such as Vueway have been consistently shown to result in significantly lower gadolinium retention compared to linear agents. The clinical significance of gadolinium retention is currently not established, and no adverse health effects have been definitively linked to the retention of gadolinium from macrocyclic agents. Regulatory agencies including the FDA and EMA continue to monitor this issue and recommend that GBCAs should be used only when clinically necessary, at the lowest effective dose, and that repeated examinations should be justified by clinical need.
Contact medical staff immediately if you experience any of the following after receiving Vueway: swelling of the face, lips, tongue, or throat; difficulty breathing or wheezing; dizziness or feeling faint; widespread skin rash or hives; rapid heartbeat or chest tightness. These symptoms may indicate a serious allergic reaction that requires emergency treatment.
How Should Vueway Be Stored?
As Vueway is administered in hospitals and imaging centers, storage is primarily the responsibility of healthcare facilities rather than patients. However, understanding proper storage conditions can be useful for patients who want to be informed about the quality and integrity of the medication they receive.
- Shelf life: Do not use Vueway after the expiration date printed on the vial or pre-filled syringe label and carton after “EXP.” The expiration date refers to the last day of the stated month.
- Vials: No special storage conditions are required. Once opened, chemical and physical in-use stability has been demonstrated for up to 24 hours at up to 25°C. From a microbiological standpoint, the product should be used immediately after opening.
- Pre-filled syringes: Do not freeze. Store according to the manufacturer’s labeling.
- Appearance: Vueway is a clear, colorless to slightly yellow solution. Do not use if the solution is not clear or if it contains visible particles.
- Single use: Each vial or pre-filled syringe is intended for single use in one patient. Any unused product must be discarded after the examination.
- Disposal: Unused medicine should not be disposed of via wastewater or household waste. Healthcare facilities follow established procedures for the safe disposal of pharmaceutical waste to protect the environment.
What Does Vueway Contain?
Understanding the composition of Vueway is important, particularly for patients with known allergies or sensitivities to specific pharmaceutical ingredients. Below is a detailed breakdown of the formulation.
Active Ingredient
The active substance is gadopiclenol, a macrocyclic gadolinium chelate. Each milliliter of solution contains 485.1 mg of gadopiclenol, which corresponds to 0.5 mmol of gadopiclenol and 78.6 mg of gadolinium. Gadopiclenol has a macrocyclic molecular structure in which the gadolinium ion is enclosed within a rigid cage-like ligand. This macrocyclic design provides high kinetic and thermodynamic stability to the complex, meaning the gadolinium ion is tightly bound and resistant to release in biological conditions. This structural stability is an important safety feature, as free (unchelated) gadolinium ions are toxic and may contribute to adverse effects including NSF.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Gadopiclenol | Active substance (gadolinium chelate) | 485.1 mg/mL (0.5 mmol/mL) |
| Tetraxetan | Chelating ligand / stabilizer | Free ligand for additional stability |
| Trometamol (Tromethamine) | Buffer (pH stabilizer) | Maintains physiological pH |
| Hydrochloric acid | pH adjustment | Used to fine-tune solution pH |
| Sodium hydroxide | pH adjustment | Used to fine-tune solution pH |
| Water for injections | Solvent | Volume to stated fill |
Appearance and Pack Sizes
Vueway is a clear, colorless to slightly yellow solution for injection. It is available in the following presentations:
- Vials: 1 vial containing 3, 7.5, 10, 15, 30, 50, or 100 mL of solution. Multi-packs of 25 vials containing 7.5, 10, or 15 mL are also available.
- Pre-filled syringes: 1 or 10 pre-filled syringes containing 7.5, 10, or 15 mL of solution. Pre-filled syringes are available with various administration sets for manual injection or use with specific power injectors (Optistar Elite or Medrad Spectris Solaris EP).
Not all pack sizes may be marketed in every country. Your hospital or imaging center will use the presentation that is most appropriate for the clinical setting and the examination being performed.
Marketing Authorization Holder and Manufacturer
The marketing authorization holder for Vueway in the European Union is Bracco Imaging S.p.A. (Milan, Italy). Manufacturing is performed by Guerbet (Aulnay-sous-Bois, France), BIPSO GmbH (Singen, Germany), and Bracco Imaging S.p.A. (Colleretto Giacosa, Italy). Vueway is approved and available in multiple countries across Europe, North America, and other regions worldwide.
Frequently Asked Questions About Vueway
Vueway (gadopiclenol) is a gadolinium-based contrast agent used to enhance MRI (magnetic resonance imaging) scans. It is injected intravenously before or during an MRI examination to improve the visualization of abnormal structures or lesions in the brain and body. By making certain areas appear brighter on MRI images, Vueway helps radiologists distinguish between healthy tissue and diseased tissue, aiding in the accurate diagnosis of conditions such as brain tumors, spinal cord lesions, liver metastases, inflammatory conditions, and vascular abnormalities. It is approved for use in adults and children aged 2 years and older.
Vueway stands out from conventional gadolinium-based contrast agents due to its uniquely high T1 relaxivity – approximately twice that of standard agents. This means each gadolinium atom in Vueway produces stronger signal enhancement on MRI images. As a result, Vueway achieves diagnostic-quality images at half the standard gadolinium dose (0.05 mmol/kg instead of 0.1 mmol/kg). This dose reduction translates to less total gadolinium delivered to the patient per examination, which is a significant advantage given current awareness about gadolinium retention in the body. Additionally, Vueway is a macrocyclic agent, which means its gadolinium ion is tightly enclosed in a stable cage-like structure, reducing the risk of gadolinium release compared to linear agents.
Vueway should be used with caution in patients with kidney (renal) impairment. It is not recommended for patients with severe renal impairment (GFR below 30 mL/min/1.73m²) due to the risk of nephrogenic systemic fibrosis (NSF), a serious condition that has been associated with gadolinium exposure in patients with poor kidney function. If Vueway must be used in such patients, only one dose should be administered per examination, with at least 7 days between subsequent doses. For patients with mild to moderate kidney impairment, Vueway can generally be used with standard precautions, but kidney function should be assessed beforehand. Your doctor may perform a blood test to evaluate your kidney function before the procedure.
This is a topic you should discuss with your doctor or radiologist. The manufacturer recommends interrupting breastfeeding for 24 hours after receiving Vueway and discarding milk produced during that period. However, several major medical organizations (including the American College of Radiology and the European Society of Urogenital Radiology) consider it safe to continue breastfeeding after receiving macrocyclic gadolinium-based contrast agents, as only very small amounts are excreted in breast milk and even less is absorbed by the infant’s digestive system. The decision should be made jointly between you and your healthcare provider based on your individual circumstances.
In patients with normal kidney function, Vueway has an elimination half-life of approximately 1.7 hours, meaning most of the contrast agent is cleared from the bloodstream within several hours. Essentially complete urinary excretion occurs within about 24 hours. However, trace amounts of gadolinium may be retained in various body tissues (including the brain, bones, and skin) for longer periods. This phenomenon occurs with all gadolinium-based contrast agents. Macrocyclic agents like Vueway have been shown to result in lower gadolinium retention than linear agents. The clinical significance of this trace retention is currently not established, and no adverse health effects have been definitively attributed to gadolinium retained from macrocyclic agents.
Yes, Vueway is approved for use in children aged 2 years and older at the same weight-based dose as adults (0.1 mL/kg body weight, equivalent to 0.05 mmol/kg). In pediatric patients, healthcare professionals use vials with a single-use syringe to achieve precise dosing. The safety profile in children has been consistent with that observed in adults in clinical trials. Vueway is not recommended for children under 2 years of age, as safety and efficacy have not been established in this age group.
References
- European Medicines Agency (EMA). Vueway (gadopiclenol) – Summary of Product Characteristics. Last updated 2025. Available at: EMA Vueway EPAR.
- U.S. Food and Drug Administration (FDA). Vueway (gadopiclenol) – Prescribing Information. Bracco Diagnostics. Revised 2024.
- Bendszus M, Roberts D, Kolumban B, et al. Dose Finding Study of Gadopiclenol, a New Macrocyclic Contrast Agent, in MRI of Central Nervous System. Invest Radiol. 2020;55(3):129–137. doi:10.1097/RLI.0000000000000624.
- Fries P, Braunagel M, Seidensticker M, et al. Gadopiclenol, a New Gadolinium-Based Contrast Agent for MRI: Results of a Phase III Multicenter Trial. Radiology. 2023;307(1):e220757. doi:10.1148/radiol.220757.
- American College of Radiology (ACR). ACR Manual on Contrast Media. Version 2024. Committee on Drugs and Contrast Media.
- European Society of Urogenital Radiology (ESUR). ESUR Guidelines on Contrast Agents. Version 10.0, 2023.
- Gulani V, Calamante F, Shellock FG, et al. Gadolinium Deposition in the Brain: Summary of Evidence and Recommendations. Lancet Neurol. 2017;16(7):564–570. doi:10.1016/S1474-4422(17)30158-8.
- World Health Organization (WHO). Diagnostic Imaging – Magnetic Resonance Imaging. Technical Report. 2023.
- British National Formulary (BNF). Gadopiclenol. National Institute for Health and Care Excellence (NICE). 2025.
- Thomsen HS. Nephrogenic Systemic Fibrosis: A Serious Adverse Reaction to Gadolinium – 1997–2006–2016. Acta Radiol. 2016;57(6):643–648. doi:10.1177/0284185115626480.
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