Primovist: Uses, Dosage & Side Effects
Liver-specific gadolinium-based MRI contrast agent (gadoxetic acid disodium) for the detection and characterization of focal liver lesions
Primovist (gadoxetic acid disodium, also sold as Eovist in the United States) is a liver-specific paramagnetic contrast agent used exclusively for magnetic resonance imaging (MRI) of the liver. Unlike conventional extracellular gadolinium contrast agents, Primovist is selectively taken up by functioning liver cells (hepatocytes) through the organic anion transporting polypeptides OATP1B1 and OATP1B3, and is subsequently excreted into the bile through the MRP2 transporter. This unique biodistribution allows a dedicated hepatobiliary imaging phase beginning approximately 10 to 20 minutes after injection, which dramatically improves detection and characterization of focal liver lesions. Primovist is administered as a single intravenous bolus injection at a dose of 0.025 mmol per kilogram (0.1 ml/kg) by trained radiology staff in a hospital or imaging centre, and is available only on prescription.
Quick Facts: Primovist
Key Takeaways
- Primovist (gadoxetic acid disodium) is a liver-specific MRI contrast agent that uniquely combines the early vascular imaging properties of a conventional gadolinium agent with a delayed hepatobiliary phase provided by active hepatocyte uptake.
- Its main clinical use is the detection and characterization of focal liver lesions, particularly to differentiate hepatocellular carcinoma (HCC) from benign lesions such as focal nodular hyperplasia (FNH) and to identify small liver metastases before surgery.
- The standard adult dose is 0.025 mmol per kilogram body weight (equivalent to 0.1 ml/kg), given as a single intravenous bolus injection, followed by a saline flush and standardized MRI image acquisition in multiple phases.
- Primovist has approximately balanced hepatobiliary (about 50 percent) and renal (about 50 percent) elimination, which provides a safer profile in mild to moderate renal impairment than purely renally excreted gadolinium agents, although caution is still required in severe renal disease.
- The most common side effects are mild and transient, including headache, nausea, and injection-site reactions; serious hypersensitivity reactions are rare, but the injection must always be administered in a facility equipped to manage emergencies.
What Is Primovist and What Is It Used For?
Primovist is the trade name for the gadolinium chelate gadoxetic acid disodium, chemically known as gadolinium ethoxybenzyl-diethylenetriamine penta-acetic acid (Gd-EOB-DTPA). It belongs to a specialized subgroup of gadolinium-based contrast agents (GBCAs) known as hepatobiliary or liver-specific contrast agents. In the United States and several other markets the same compound is sold under the brand name Eovist. It is manufactured by Bayer AG and was first approved by the European Medicines Agency (EMA) in 2004 and by the U.S. Food and Drug Administration (FDA) in 2008.
Like all gadolinium-based contrast agents, Primovist works by altering the way the tissues in your body relax after being exposed to a strong magnetic field in the MRI scanner. The gadolinium atom is paramagnetic, which means it markedly shortens the T1 relaxation time of nearby water molecules. On T1-weighted images, tissues containing Primovist therefore appear much brighter than they would without contrast. Because gadolinium is toxic in its free form, it is tightly bound (chelated) to a specially designed organic ligand. The ethoxybenzyl (EOB) side group attached to the DTPA ligand is what gives Primovist its unique hepatobiliary behaviour.
After intravenous injection, Primovist behaves initially like a conventional extracellular gadolinium agent: it distributes rapidly through the blood vessels and then into the extracellular space, producing the usual dynamic arterial, portal venous, and equilibrium (late) phases of a liver MRI. However, approximately 50 percent of the injected dose is subsequently taken up by functioning hepatocytes through the organic anion transporting polypeptides OATP1B1 and OATP1B3. Once inside the hepatocytes, gadoxetic acid is eventually excreted unchanged into the bile canaliculi via the multidrug resistance-associated protein 2 (MRP2). The remaining 50 percent of the dose is excreted unchanged by the kidneys through glomerular filtration.
This dual elimination pathway is the key to Primovist's clinical advantage. Starting about 10 minutes after injection and remaining optimal for approximately 20 to 30 minutes, the healthy liver parenchyma becomes strongly enhanced on T1-weighted images, while most focal lesions that do not contain normal hepatocytes (such as metastases, cysts, and many primary liver cancers) appear as dark defects against the bright liver background. This hepatobiliary phase dramatically improves the detection of small lesions and, in combination with the earlier dynamic phases, helps radiologists distinguish benign from malignant liver tumours.
Approved Indications
Primovist is approved by the EMA, the FDA, and regulatory authorities in many other countries for the following indication:
- Detection and characterization of focal liver lesions in adults using T1-weighted magnetic resonance imaging of the liver, when additional information beyond that obtainable from unenhanced MRI is required.
Within this broad indication, Primovist is particularly useful in the following clinical scenarios:
Hepatocellular Carcinoma (HCC)
Primovist has become a cornerstone in the non-invasive diagnosis of hepatocellular carcinoma, especially in patients with chronic liver disease or cirrhosis who are at high risk. HCC typically arises from dedifferentiated hepatocytes that lose expression of the OATP transporters and therefore fail to take up Primovist during the hepatobiliary phase. The combination of arterial phase hyperenhancement, washout on the portal venous or transitional phase, and hypointensity on the hepatobiliary phase provides a highly specific imaging signature. Major international guidelines, including those from the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Diseases (AASLD), the Asian Pacific Association for the Study of the Liver (APASL), and the Liver Imaging Reporting and Data System (LI-RADS), now incorporate gadoxetic acid-enhanced MRI as an accepted imaging modality for HCC diagnosis and surveillance.
Focal Nodular Hyperplasia (FNH) and Hepatic Adenomas
Primovist is highly valuable for distinguishing focal nodular hyperplasia from hepatic adenomas, which can be difficult to differentiate on other imaging modalities. FNH contains functioning hepatocytes and abnormal bile ductules that retain or trap Primovist, so these lesions typically appear iso- or hyperintense (equal to or brighter than the surrounding liver) in the hepatobiliary phase. Hepatic adenomas generally lack normal biliary drainage and therefore usually appear hypointense (darker). This distinction has important clinical implications, since hepatic adenomas may require surgical treatment due to the risk of bleeding and malignant transformation, while FNH is a benign lesion that rarely requires intervention.
Liver Metastases
Primovist significantly improves the detection of small liver metastases, particularly from colorectal cancer. Because metastatic lesions do not contain normal hepatocytes, they appear as sharply defined dark lesions against the bright liver background in the hepatobiliary phase. Several comparative studies have shown that gadoxetic acid-enhanced MRI detects more and smaller metastases than multidetector CT and than MRI with conventional extracellular gadolinium agents. This improved sensitivity can alter surgical planning before liver resection and may avoid unnecessary surgery when unresectable disease is identified.
Cholangiocarcinoma and Biliary Assessment
Because Primovist is excreted into the bile, it also provides functional information about the biliary system. Prolonged delayed imaging can be used as a form of MR cholangiography to evaluate biliary leaks, identify anatomical variants before liver transplantation or surgery, and assess the extent of cholangiocarcinoma. Although Primovist is not designed primarily for biliary imaging, the additional biliary information obtained during a liver examination is often clinically useful.
Unlike standard extracellular gadolinium-based contrast agents (such as gadobutrol, gadoterate, or gadobenate), Primovist is actively transported into liver cells by specific membrane carriers. This active uptake is responsible for both its unique hepatobiliary imaging phase and its dual route of elimination. It is important to understand that Primovist is not used for brain, cardiac, musculoskeletal, or general vascular MRI; for those examinations, other gadolinium agents are preferred.
What Should You Know Before Receiving Primovist?
Contraindications
Primovist must not be administered in the following situations:
- Hypersensitivity: Do not use Primovist if you have a known severe allergic or hypersensitivity reaction to gadoxetic acid disodium or to any of the excipients in the formulation (including trisodium caloxetate and trometamol). A previous non-severe reaction is not an absolute contraindication but requires careful risk assessment and often premedication or use of an alternative agent.
The EMA summary of product characteristics does not list severe renal impairment as an absolute contraindication for Primovist, but regulatory authorities require a formal benefit-risk assessment in patients with an estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73 m2 because of the theoretical risk of nephrogenic systemic fibrosis (see below).
Warnings and Precautions
As with all contrast agents, Primovist can rarely cause severe, unpredictable hypersensitivity reactions including anaphylactic shock, angio-oedema, laryngeal oedema, and cardiovascular collapse. These reactions can occur within minutes of the injection or, more rarely, several hours later. Primovist must therefore always be administered in a facility where emergency resuscitation equipment and trained personnel are immediately available. Patients should be observed during and for at least 30 minutes after the injection. Patients with a history of asthma, bronchospasm, drug allergy, or a previous reaction to any contrast agent are at higher risk.
Inform the radiology staff before the examination if any of the following applies to you:
- Previous contrast reaction: Any previous reaction to iodinated (CT) or gadolinium-based (MRI) contrast agents increases the risk of a reaction to Primovist. Tell your radiologist, who may prescribe premedication with corticosteroids and antihistamines, or choose a different agent.
- Asthma or allergic disease: Poorly controlled asthma, severe hay fever, eczema, or a history of drug allergies increases the risk of a reaction. Ensure your asthma is well controlled before the scan.
- Kidney disease: If you have known chronic kidney disease, have had a kidney transplant, are on dialysis, or have recently had an episode of acute kidney injury, the radiologist will check your current eGFR and weigh the benefits of Primovist against the small risk of nephrogenic systemic fibrosis in severe renal impairment.
- Heart disease: In patients with severe cardiovascular disease, transient cardiovascular adverse effects (such as changes in blood pressure or heart rhythm) may be less well tolerated. Tell your doctor if you have unstable angina, severe heart failure, or a history of serious arrhythmia.
- Seizure disorders: Although rare, convulsions have been reported after gadolinium contrast administration. Inform the radiology team if you have a history of epilepsy or a lowered seizure threshold.
- Low sodium diet: Primovist contains 0.23 mmol (5.3 mg) of sodium per ml. This should be considered for patients on a controlled sodium diet, although the absolute amount in a single injection is small.
Nephrogenic systemic fibrosis is a rare but serious condition characterized by progressive skin thickening and fibrosis of internal organs that has been linked to gadolinium-based contrast agents in patients with severe renal impairment. Primovist is classified by both the EMA and the FDA as an intermediate-risk (group II) agent based on a macrocyclic-like stability profile and balanced elimination, but the theoretical risk cannot be entirely excluded. Current guidelines recommend that in patients with an eGFR below 30 ml/min/1.73 m2, Primovist should be used only after careful risk-benefit assessment and at the lowest diagnostic dose.
Gadolinium Retention in the Body
Small amounts of gadolinium may be retained for months to years in various tissues, including the brain (particularly the dentate nucleus and globus pallidus), bone, skin, and internal organs, after administration of gadolinium-based contrast agents. The clinical significance of this retention in otherwise healthy patients is currently unknown, and no adverse health effects have been conclusively established. However, regulatory agencies recommend that the lowest effective dose be used and that contrast-enhanced MRI be limited to situations where it offers a clear diagnostic benefit, particularly in patients who may require repeated lifetime examinations.
Pregnancy and Breastfeeding
Primovist should not be used during pregnancy unless the clinical condition of the mother requires the use of gadoxetic acid and no suitable alternative imaging technique is available. Gadolinium-based contrast agents cross the placenta and appear in the fetal circulation; although no specific fetal harm has been conclusively demonstrated in humans, the long-term consequences of fetal gadolinium exposure are unknown. Where possible, MRI during pregnancy should be performed without contrast.
After administration of Primovist, the manufacturer recommends that breastfeeding be discontinued for at least 24 hours to minimize any possible gadolinium exposure to the infant. International expert guidelines, including those of the ACR and ESUR, now consider continued breastfeeding acceptable after gadolinium contrast agents because less than 0.04 percent of the administered dose is excreted into breast milk and an even smaller fraction is absorbed by the infant. Patients should discuss the balance of risks and benefits with their doctor and radiologist.
Children and Adolescents
Primovist is approved in the EU for use in children of all ages, including neonates, for the diagnosis of focal liver lesions when MRI is needed and an extracellular contrast agent is not sufficient. In the United States, Eovist is approved for patients aged two months and older. The safety and efficacy profile in children is similar to that in adults. Paediatric dosing is weight-based (0.025 mmol/kg). In very young children and infants, immature liver function and lower OATP expression may reduce hepatobiliary phase enhancement.
Driving and Operating Machinery
Primovist itself is not expected to affect the ability to drive. However, some patients may experience transient dizziness, headache, or nausea after the injection or after the MRI examination. If you experience any of these symptoms, do not drive until they have resolved. If sedation was used to help you tolerate the MRI scan, you should not drive for at least 24 hours and must follow specific local anaesthetic or sedation instructions.
How Does Primovist Interact with Other Drugs?
Primovist does not undergo any significant metabolism in the human body; it is excreted unchanged in bile and urine. As a result, it does not inhibit or induce cytochrome P450 enzymes and has minimal potential for classical pharmacokinetic drug-drug interactions. However, because its hepatobiliary uptake is actively mediated by specific membrane transporters, medications that compete for these transporters can potentially reduce hepatic enhancement and affect diagnostic quality.
Tell the radiology team and your referring doctor about all medications, supplements, and recent imaging studies, including over-the-counter products and herbal remedies. The radiologist will consider these when interpreting your images and may recommend rescheduling the examination or adjusting timing to avoid pharmacological interference.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Rifampicin (strong OATP1B1/1B3 inhibitor) | Competes with gadoxetic acid for hepatocyte uptake, reducing hepatobiliary phase signal and delaying biliary excretion | Avoid concomitant use where possible; consider alternative hepatic imaging or postpone if clinically acceptable |
| Ciclosporin (OATP1B1/1B3 and MRP2 inhibitor) | Reduced hepatocyte uptake and biliary excretion, potentially decreasing the quality of the hepatobiliary phase | Inform the radiologist; imaging may still be diagnostic but images should be interpreted with caution |
| Other iodinated contrast agents (recent CT) | Bilirubin elevation or serum albumin competition may reduce hepatocyte transporter activity | Ideally wait at least 24 hours between iodinated CT contrast and Primovist-enhanced MRI |
| Previous gadolinium contrast within 24 hours | Residual contrast in the extracellular space may interfere with quantitative image analysis | Space examinations by at least 7 hours for elimination; 24 hours or more is preferred |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Erythromycin (weak OATP inhibitor) | Mild reduction in hepatocyte uptake possible | Generally clinically insignificant; monitor hepatobiliary phase quality |
| Probenecid | Theoretical reduction in renal tubular secretion of gadoxetic acid | Unlikely to be clinically relevant at a single diagnostic dose |
| Statins (OATP1B1 substrates, e.g. rosuvastatin, simvastatin) | Competitive inhibition is theoretically possible; clinical studies show minimal effect at standard doses | No need to interrupt statin therapy for a single Primovist study |
| Beta-blockers (e.g. propranolol, metoprolol) | May blunt the physiological response to an anaphylactic reaction and complicate resuscitation | Do not discontinue; ensure emergency preparations include glucagon availability |
| Elevated bilirubin (cholestasis, liver failure) | High endogenous bilirubin competes with gadoxetic acid for OATP transport, reducing hepatocyte uptake | The hepatobiliary phase is often of limited diagnostic value at total bilirubin above 3 mg/dl (51 micromol/l) |
Laboratory test interference should also be considered. Serum iron determinations by complexometric methods may give falsely low values up to 24 hours after administration of Primovist, because gadolinium chelates interfere with some colorimetric assays. Other routine laboratory tests are not affected.
What Is the Correct Dosage of Primovist?
Primovist is always administered by a radiologist, radiographer, or trained nurse as an intravenous injection, typically through a peripheral venous cannula in the arm. The dose is calculated individually based on body weight. Unlike chemotherapy agents, no premedication is required in patients without a history of contrast reaction or severe allergic disease.
Adults
Standard Adult Dose
Dose: 0.025 mmol of gadoxetic acid disodium per kilogram body weight
Volume: 0.1 ml per kilogram of the 0.25 mmol/ml solution (for example, 7 ml for a 70 kg adult)
Administration: Single intravenous bolus injection at approximately 2 ml/second, followed by a 20 to 30 ml saline (0.9 percent sodium chloride) flush
Imaging timing: Dynamic phases (arterial, portal venous, and equilibrium) in the first 3 to 5 minutes, followed by the hepatobiliary phase at 10 to 20 minutes after injection (optimally 20 minutes in most patients)
Children and Neonates
Paediatric Dose (all ages, including neonates)
Dose: 0.025 mmol per kilogram body weight
Volume: 0.1 ml per kilogram of the 0.25 mmol/ml solution
Administration: Slow intravenous injection; the hepatobiliary phase may need to be acquired slightly later than in adults because of age-related differences in transporter expression and hepatocyte function
Note: In the United States (Eovist), approval is limited to patients aged 2 months and older
Elderly Patients
Patients Aged 65 Years or Older
Dose: Same as standard adult dose (0.025 mmol/kg)
Considerations: No dose adjustment is required on the basis of age alone. However, kidney function declines with age, so estimated glomerular filtration rate (eGFR) should be confirmed in patients over 65 years, particularly those with diabetes, hypertension, or other risk factors for renal impairment.
Renal Impairment
Mild to Moderate Renal Impairment (eGFR 30 to 89 ml/min/1.73 m²)
Dose: Standard 0.025 mmol/kg. No dose reduction is required because Primovist is eliminated roughly equally by the liver and kidneys.
Monitoring: No special monitoring is recommended beyond routine radiology practice.
Severe Renal Impairment (eGFR below 30 ml/min/1.73 m²)
Dose: Use only after careful risk-benefit assessment. If used, the standard dose of 0.025 mmol/kg should not be exceeded.
Monitoring: No more than one dose should be administered within 7 days to allow elimination. Patients on dialysis should undergo dialysis as soon as possible after the examination, although dialysis is not a reliable means of preventing nephrogenic systemic fibrosis.
Hepatic Impairment
No dose adjustment is required in mild to moderate hepatic impairment. In severe hepatic dysfunction, biliary excretion may be substantially reduced, which will diminish the diagnostic value of the hepatobiliary phase but does not increase the risk of toxicity because renal elimination is preserved. In patients with high serum bilirubin (typically above 3 mg/dl or 51 micromol/l), the hepatobiliary phase often provides limited diagnostic information and an alternative imaging strategy may be preferred.
Missed or Failed Injection
Because Primovist is administered in a clinical setting as a single injection per examination, the concept of a missed dose does not apply in the usual sense. If the injection fails (for example, due to extravasation or loss of venous access), the radiologist will decide whether a repeat injection is appropriate based on the estimated amount delivered, the extent of extravasation, and the clinical priority of the scan. Do not attempt to "top up" the dose yourself.
Overdose
No case of human overdose has been reported. In clinical studies, single doses of up to 0.4 mmol/kg (16 times the diagnostic dose) were well tolerated. In the event of accidental overdose, the patient should be monitored clinically and treated symptomatically. Gadoxetic acid can be removed by haemodialysis, although this is not routinely required.
How Primovist Is Given
Primovist is supplied in prefilled glass syringes or vials as a clear, colourless to pale yellow solution at a concentration of 0.25 mmol/ml. Before administration, the solution is inspected visually for particulates and discolouration; any discoloured or contaminated solution must be discarded. The calculated dose is drawn up or connected to a power injector and administered through a suitable peripheral intravenous cannula. Injection into a vein in the antecubital fossa is preferred to minimize the risk of extravasation. The injection is followed by a saline flush of at least 20 ml to ensure complete delivery of the dose into the circulation.
After the injection, you will be moved back into the MRI scanner for the dynamic phases. Approximately 10 to 15 minutes after injection, you may be given a short break before the hepatobiliary phase images are acquired, typically around 20 minutes after injection. The entire examination, including setup and post-processing, usually takes 30 to 60 minutes.
Primovist is exclusively for intravenous use in a medical imaging facility and must never be self-administered, injected intramuscularly, or taken by any other route. It must not be mixed in the same syringe or infusion line with other medications. Extravasation (leakage into surrounding tissues) can cause local pain, swelling, and rarely skin damage, and should be reported immediately to the radiology staff.
What Are the Side Effects of Primovist?
Like all medicines, Primovist can cause side effects, although not everyone experiences them. In post-marketing experience involving several million administrations worldwide, the overall rate of side effects has been low, with most reported effects being mild and self-limiting. The side effects listed below are based on clinical trials and post-marketing surveillance data collated in the EMA Summary of Product Characteristics.
The side effects are organized by frequency category, reflecting how commonly they have been observed. Your radiology team will watch for signs of adverse reactions during and after your injection.
Common
May affect up to 1 in 10 people
- Headache
- Nausea
Uncommon
May affect up to 1 in 100 people
- Dizziness, sensation of spinning (vertigo)
- Tingling, prickling, or “pins and needles” sensation (paraesthesia)
- Altered or unpleasant taste in the mouth (dysgeusia)
- Vomiting, dry mouth
- Abdominal pain, abdominal discomfort
- Rash
- Back pain
- Chest pain
- Injection-site reactions (warmth, coldness, burning, pain, or irritation)
- Feeling hot or cold, flushing, pallor
- Chills, fatigue, general feeling of being unwell (malaise)
- Increased blood pressure
- Respiratory symptoms (shortness of breath, nasal congestion, sneezing)
- Itching (pruritus), including generalized and localized pruritus
- Excessive sweating
Rare
May affect up to 1 in 1,000 people
- Restlessness, anxiety
- Tremor
- Loss of consciousness, syncope (fainting)
- Reduced sense of touch (hypoaesthesia)
- Smell disturbances (parosmia)
- Heart racing (palpitations), irregular heart rhythm, bundle branch block
- Fast heart rate (tachycardia)
- Difficulty breathing (dyspnoea), respiratory distress
- Oropharyngeal discomfort, laryngeal discomfort, sensation of throat tightening
- Hypersensitivity reactions including angioedema (swelling of face, lips, tongue), conjunctivitis, and urticaria (hives)
- Cold sweats
- Feeling of generalized warmth
Very Rare and Post-Marketing
May affect fewer than 1 in 10,000 people
- Anaphylactic or anaphylactoid shock with circulatory collapse
- Severe laryngeal or pharyngeal oedema
- Bronchospasm or acute asthma exacerbation
- Nephrogenic systemic fibrosis (reported almost exclusively in patients with severe renal impairment who received multiple or high doses of various gadolinium agents)
- Transient cardiac arrhythmias, including atrioventricular block
- Extravasation with local tissue reactions, cellulitis, or very rarely tissue necrosis
Not Known
Frequency cannot be estimated from available data
- Gadolinium deposition in the brain, bone, skin, and other tissues (clinical significance currently unknown)
- Fibrosing skin lesions mimicking nephrogenic systemic fibrosis in patients with preserved kidney function (extremely rare)
- Signal intensity increase on unenhanced T1-weighted brain MRI in patients who have received multiple doses
It is important to report any suspected side effect to your healthcare provider. Reporting helps regulatory authorities continuously monitor the benefit-risk balance of medicines. You can also report side effects directly to your national pharmacovigilance agency (for example, the FDA MedWatch programme in the United States, the Yellow Card scheme in the United Kingdom, or the EMA EudraVigilance system in the European Union).
Seek emergency medical care immediately if you develop any of the following after a Primovist injection: difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, severe rash or hives, severe dizziness or fainting, chest pain, or a rapid or irregular heartbeat. Late reactions can occur hours or even days after the examination.
How Should Primovist Be Stored?
As a hospital-administered product, storage of Primovist is managed by pharmacy and radiology staff. However, understanding the basic storage principles may help patients and healthcare workers outside radiology appreciate how the product is kept safe and effective.
- Temperature: Store at or below 25°C (77°F). Do not freeze. Primovist does not require refrigeration.
- Protection from light: Keep the container in the original outer carton until immediately before use to protect from light.
- Container integrity: Inspect each vial or prefilled syringe before use. Do not use if the solution is cloudy or severely discoloured, if particles are present, or if the container is damaged.
- Single use only: Primovist is supplied as a single-dose product. Any portion of the solution not used for a single examination must be discarded. Do not save opened or partially used vials for a later patient.
- Stability after withdrawal: Once drawn up into a syringe for administration, Primovist should be used promptly. Chemical and physical in-use stability has been demonstrated for up to 24 hours at 20 to 25°C; however, from a microbiological perspective, immediate use is recommended.
- Expiry date: Do not use Primovist after the expiry date (EXP) printed on the packaging. The expiry date refers to the last day of the stated month.
- Keep out of the reach and sight of children.
- Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for pharmaceutical waste.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use; these measures will help protect the environment.
What Does Primovist Contain?
Understanding what Primovist contains is important for identifying potential allergens and explaining the chemistry behind its imaging properties.
- Active substance: Gadoxetic acid disodium, also known as disodium gadoxetate or Gd-EOB-DTPA. Each millilitre of solution contains 181.43 mg of gadoxetic acid disodium (equivalent to 0.25 mmol).
- Excipients: Trisodium caloxetate (used to bind any free gadolinium and enhance complex stability), trometamol (a buffer), sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injection.
- Sodium content: Primovist contains approximately 0.23 mmol (5.3 mg) of sodium per millilitre. A standard adult dose of 7 ml in a 70 kg adult therefore delivers about 37 mg of sodium, which is clinically negligible but should be noted in patients on strictly sodium-restricted diets.
Appearance: Primovist is a clear, colourless to pale yellow aqueous solution. It is isotonic, with an osmolality of approximately 688 mOsm/kg H2O at 37°C, slightly higher than plasma. The pH is approximately 7.0 to 7.6, similar to physiological pH, which contributes to good local tolerability.
Pack sizes: Primovist is supplied in several presentations depending on the market, including glass vials of 5 ml, 7.5 ml, and 10 ml, and prefilled glass syringes of 5 ml, 7.5 ml, and 10 ml. Each carton typically contains 1 or 5 units.
Marketing authorization holder: Bayer AG, 51368 Leverkusen, Germany. In the United States, the same product is marketed by Bayer HealthCare Pharmaceuticals under the brand name Eovist.
Other Brand Names
Gadoxetic acid disodium (Gd-EOB-DTPA) is marketed under two main brand names worldwide. In Europe, most of Asia, Latin America, and many other regions it is sold as Primovist. In the United States and Canada it is marketed as Eovist. Both products contain the same active substance at the same concentration and are functionally interchangeable.
Frequently Asked Questions About Primovist
Primovist is a liver-specific MRI contrast agent. Unlike conventional extracellular gadolinium agents, approximately half of the injected Primovist is actively taken up by functioning liver cells and then excreted into the bile. This creates a delayed hepatobiliary imaging phase 10 to 20 minutes after injection during which the healthy liver becomes bright and most focal liver lesions appear dark. This dramatically improves detection and characterization of liver tumours, especially hepatocellular carcinoma, focal nodular hyperplasia, and colorectal metastases. For examinations of other organs (brain, heart, musculoskeletal system, general vascular studies), a standard extracellular gadolinium agent is preferred.
Most patients feel only a brief sensation in the arm where the contrast is injected. Because Primovist is administered as a small-volume bolus (typically 5 to 10 ml) immediately followed by a saline flush, some patients describe a momentary warmth or coldness spreading from the injection site, a metallic or unusual taste in the mouth, or a mild flushing sensation. These feelings typically resolve within a minute or two. If you experience pain, significant burning, or swelling at the injection site, tell the radiology team immediately, as these may indicate that the contrast has leaked outside the vein.
In patients with normal kidney and liver function, Primovist is eliminated rapidly. The elimination half-life is approximately 1 hour, and the vast majority of the dose is excreted within 24 hours through the combined action of the kidneys (into urine) and the liver (into bile and then stool). However, very small amounts of gadolinium may be retained for months to years in tissues such as bone, brain, and skin after any gadolinium-based contrast agent. The clinical importance of this residual gadolinium in otherwise healthy people is not established, but regulators recommend using the lowest effective dose and avoiding unnecessary contrast-enhanced examinations.
Yes. After the examination you are generally encouraged to drink plenty of water for the rest of the day, unless you have been told to restrict fluids for other medical reasons (such as heart failure or severe kidney disease). Good hydration supports normal kidney function and helps the body eliminate the contrast. However, the main route of elimination for Primovist is dual (renal and biliary), and the pharmacokinetics are not dramatically changed by increased fluid intake. Always follow the specific advice of your doctor or radiology team.
Gadolinium-based contrast agents, including Primovist, are chemically very different from iodinated CT contrast agents. A previous reaction to iodinated contrast does not automatically mean you will react to Primovist, but it does identify you as a higher-risk patient. The radiology team will review your history carefully and may consider premedication with a corticosteroid and antihistamine before the examination, or choose a different imaging strategy. Always inform your radiologist of any previous contrast reaction, the type of contrast involved, and the severity of the reaction.
Fasting is not strictly required for contrast safety, but many centres ask patients to avoid solid food for 4 to 6 hours before a Primovist-enhanced liver MRI. This reduces movement artefacts caused by gallbladder contraction and bowel peristalsis, which can obscure the liver and biliary tree. Clear liquids are usually allowed up to the time of the scan. Routine medications should generally be continued unless specifically instructed otherwise. Follow the preparation instructions given by your imaging centre, which may vary depending on local protocols.
Primovist itself has no interaction with metal implants. However, the MRI scanner uses very strong magnetic fields, and your eligibility for MRI depends on the type of implant. Modern MRI-conditional pacemakers, defibrillators, and many orthopaedic implants can be safely scanned under specific protocols. Older devices and certain cerebral aneurysm clips, cochlear implants, or embedded metal fragments (for example from welding injuries) may be contraindications. The MRI safety screening is performed separately from the decision about contrast, so discuss both your implants and your contrast history with the radiology team before the examination.
References
- European Medicines Agency (EMA). Primovist – Summary of Product Characteristics (SmPC). Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/primovist
- U.S. Food and Drug Administration (FDA). Eovist (gadoxetate disodium) – Prescribing Information. Last updated 2024.
- European Society of Urogenital Radiology (ESUR). ESUR Guidelines on Contrast Media, Version 10.0. Contrast Media Safety Committee. 2023.
- American College of Radiology (ACR). ACR Manual on Contrast Media. ACR Committee on Drugs and Contrast Media. 2024 edition.
- Hamm B, Staks T, Mühler A, et al. Phase I clinical evaluation of Gd-EOB-DTPA as a hepatobiliary MR contrast agent: safety, pharmacokinetics, and MR imaging. Radiology. 1995;195(3):785-792. doi:10.1148/radiology.195.3.7754011
- Halavaara J, Breuer J, Ayuso C, et al. Liver tumor characterization: comparison between liver-specific gadoxetic acid disodium-enhanced MRI and biphasic CT – a multicenter trial. Journal of Computer Assisted Tomography. 2006;30(3):345-354.
- Hammerstingl R, Huppertz A, Breuer J, et al. Diagnostic efficacy of gadoxetic acid (Primovist)-enhanced MRI and spiral CT for a therapeutic strategy: comparison with intraoperative and histopathologic findings in focal liver lesions. European Radiology. 2008;18(3):457-467. doi:10.1007/s00330-007-0716-9
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