Medically reviewed on March 25, 2018
(gad oh BEN ate dye MEG loo meen)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
MultiHance: 529 mg/mL (5 mL, 10 mL, 15 mL, 20 mL, 50 mL, 100 mL)
Brand Names: U.S.
- Diagnostic Agent
- Gadolinium-Containing Contrast Agent
- Radiological/Contrast Media, Nonionic (High Osmolality)
- Radiological/Contrast Media, Paramagnetic Agent
Gadobenate dimeglumine is a gadolinium-containing paramagnetic agent. Exposure to an external magnetic field induces a large local magnetic field in exposed tissues. This local magnetism disrupts water protons in the vicinity, resulting in a change in proton density and spin characteristics, which can be detected by the imaging device.
Vd: 0.17 to 0.282 L/kg; Distribution half-life: 0.084 to 0.605 hours
Gadobenate and dimeglumine dissociate after injection; pharmacokinetics are based on gadobenate; there is no additional biotransformation of gadobenate
Urine (78% to 96%); feces
Normal renal function: ~1 to 2 hours
CrCl 30 to 60 mL/minute: ~6 hours
CrCl 10 to 30 mL/minute: ~9.5 hours
End-stage renal disease (ESRD) (without dialysis): ~42 hours
Special Populations: Renal Function Impairment
Elimination half-life was 6.1 ± 3 and 9.5 ± 3.1 hours for the moderate and severe renal impairment groups, respectively, compared with 1 to 2 hours in healthy patients. In patients with end-stage renal disease requiring hemodialysis, approximately 72% of the dose was recovered by hemodialysis over a 4-hour period. The mean elimination half-life on dialysis was 1.21 ± 0.29 hours compared with 42.4 ± 24.4 hours when off dialysis.
Special Populations: Elderly
Clearance appeared to decrease slightly with increasing age.
Special Populations: Children
The geometric mean maximum plasma concentration (Cmax) was 62.3 mcg/mL in children 2 to 5 years of age and 64.2 mcg/mL in children older than 5 years of age. The geometric mean area under the curve (AUC0-∞) was 77.9 mcg•h/mL in children 2 to 5 years of age and 82.6 mcg•h/mL in children older than 5 years of age. The geometric mean half-life was 1.2 hours in children 2 to 5 years of age and 0.93 hours in children older than 5 years of age. More than 80% of the dose was recovered in urine after 24 hours. Pharmacokinetic simulations indicate similar AUC and Cmax values for children younger than 2 years of age compared to those reported for adults.
Use: Labeled Indications
CNS imaging: Magnetic resonance imaging (MRI) agent to visualize CNS lesions in adults and pediatric patients with abnormal blood brain barrier or abnormal vascularity in the brain, spine, and associated tissues
Renal and aorto-ilio-femoral vasculature imaging: Magnetic resonance angiography (MRA) agent to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease
Hypersensitivity to gadobenate dimeglumine, any gadolinium-based contrast agent, or any component of the formulation
CNS imaging: IV: 0.1 mmol/kg (0.2 mL/kg)
Renal and aorto-ilio-femoral vasculature imaging: IV: 0.1 mmol/kg (0.2 mL/kg); calculate scan delay with test bolus (1 to 2 mL) or with automatic detection technique
Refer to adult dosing.
CNS imaging: IV:
Infants and Children <2 years of age: 0.05 to 0.1 mmol/kg (0.1 to 0.2 mL/kg)
Children ≥2 years and Adolescents: Refer to adult dosing.
Dosing: Renal Impairment
Dose adjustment is not recommended; however, use with caution. Risk for NSF development increases as renal function decreases.
Hemodialysis: If administered to patients already receiving hemodialysis, consider prompt hemodialysis following exposure (eg, within 3 hours) (Kuo, 2007). Data has shown hemodialysis enhances gadolinium elimination with average gadolinium excretory rates of 78%, 96%, and 99% in the first, second, and third hemodialysis sessions, respectively (Kuo, 2007; Okada, 2001).
Peritoneal dialysis: Likely to be less efficient at clearing gadolinium (Joffe, 1998; Kuo, 2007).
Dosing: Hepatic Impairment
Child-Pugh class B or C: Pharmacokinetics were not significantly altered; dose adjustment is not recommended.
Visually inspect prior to use; do not use if discolored or if particulate matter present. Pharmacy bulk package vial should only be entered once (using a suitable transfer device). Do not mix with other medications, including parenteral nutrition.
IV: Administer as rapid IV bolus injection. To ensure complete injection of medium, flush line with NS after administration using at least 5 mL (for CNS imaging) or at least 20 mL (for renal or aorto-ilio-femoral vasculature imaging). Do not administer other medications in the same IV line. May begin imaging immediately after administration.
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; initiate hyaluronidase antidote; elevate extremity.
Hyaluronidase: Intradermal or SubQ: Inject a total of 1 mL (15 units/mL) as five separate 0.2 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; Zenk 1981) or injection of a total of 5 mL (150 units/mL) as five separate 1 mL injections around the extravasation site has been also used successfully (Rowlett 2012).
Store at controlled room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Pharmacy bulk package must be discarded within 8 hours after opening in a sterile environment; discard unused portion after 8 hours (storage temperature should not exceed 25°C [77°F] during this time frame). If drawn into a plastic disposable syringe for administration, use immediately after preparation.
Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Macimorelin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
QTc-Prolonging Agents (Highest Risk): QTc-Prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy
QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Moderate Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Xipamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy
May cause transient increase in serum ferritin, urine zinc (with renal disease), or bilirubin (with hepatic metabolic disorders)
1% to 10%:
Central nervous system: Feeling hot (1%), headache (1%)
Gastrointestinal: Nausea (1%), vomiting (≤1%)
Local: Injection site reaction (1%)
<1%, postmarketing, and/or case reports: Abdominal pain, altered sense of smell, anaphylactic shock, anaphylactoid reaction, anaphylaxis, basophilia, chest pain, chills, diarrhea, dizziness, dysgeusia, dyspnea, ECG abnormality (including PR, QRS, QT, and ST-T segment changes), eye pruritus, facial edema, fatigue, fever, first-degree atrioventricular block, hyperhidrosis, hypersensitivity reaction, laboratory test abnormality (including blood chemistry, hematology, hepatic enzymes, urinalysis), laryngospasm, loss of consciousness, malaise, myalgia, nasal congestion, necrotizing pancreatitis (acute), ocular hyperemia, oral paresthesia, pain, paresthesia, pruritus, pulmonary edema, seizure, shock, sneezing, skin rash, swelling of lips, tongue edema, tremor, urticaria, visual disturbance, weakness, wheezing, xerostomia
Concerns related to adverse effects:
• Arrhythmias: Cardiac arrhythmias have been observed; use with caution in patients with predisposing proarrhythmic conditions or concurrent proarrhythmic drug therapy. Although average changes in QTc compared to placebo were minimal (<5 msec) and no patients experienced malignant arrhythmias, numerically more patients experienced QTc prolongation between 30-60 msecs and ≥61 msecs compared to placebo in one clinical trial.
• Extravasation: Vesicant; ensure proper needle or catheter placement prior to and during administration. Avoid extravasation. May cause injection site reactions (local burning/pain, swelling, blistering, and necrosis).
• Gadolinium retention: Gadolinium is retained for months or years in brain, bone, skin, and other organs (kidney, liver, spleen); the highest concentration and longest duration have been found in the bone. Linear GBCAs (gadodiamide and gadoversetamide > gadoxetate disodium, gadopentetate dimeglumine, and gadobenate dimeglumine) result in more retention than macrocyclic GBCAs (gadoterate meglumine, gadobutrol, and gadoteridol). Pathologic and clinical consequences of gadolinium retention in skin and other organs have been established in patients with impaired renal function; there also have been rare reports of pathologic skin changes in patients with normal renal function. Consequences of gadolinium retention in the brain or in patients with normal renal function have not been established. Patients with normal renal function that may be at higher risk for gadolinium retention include: patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions; take GBCA retention characteristics into consideration for these patients. Minimize repetitive GBCA imaging studies.
• Hypersensitivity reactions: Anaphylactic and anaphylactoid reactions (some fatal) have occurred (with cardiovascular, respiratory or dermatologic involvement); symptoms typically occurred within minutes of administration. Monitor patients closely during and for up to 2 hours after infusion. If hypersensitivity occurs, begin immediate management. Appropriate equipment (eg, ventilator) and emergency medications (eg, epinephrine) should be available during use. Delayed reactions may also occur (within several hours of administration). Patients with a history of allergic reactions and/or bronchial asthma may be at an increased risk for developing hypersensitivity reactions; use caution in these patients.
• Nephrogenic systemic fibrosis: [US Boxed Warning]: Gadolinium-based contrast agents (GBCAs) exposure increases the risk for nephrogenic systemic fibrosis (NSF) in patients with renal impairment; avoid use unless GBCA enhanced imaging is essential for diagnostic purposes. The risk is highest in patients with acute kidney injury or chronic, severe renal disease (glomerular filtration rate [GFR] <30 mL/minute/1.73 m2). NSF may result in debilitating or fatal systemic fibrosis; affects the skin, muscle, and internal organs. Prior to administration, screen all patients for acute kidney injury or other conditions which may reduce renal function; estimate GFR in patients at risk for chronic declines in renal function (eg, age >60, chronic hypertension, diabetes). Do not exceed the recommended dose and allow a sufficient interval between readministration in patients at risk for NSF. The risk for NSF appears lower in patients with moderate, chronic renal disease (GFR 30 to 59 mL/minute/1.73 m2) and little, if any, in patients with mild, chronic renal disease (GFR 60 to 89 mL/minute/1.73 m2). In patients receiving hemodialysis, consider prompt initiation of hemodialysis following administration. If NSF occurs, report to manufacturer or the Food and Drug Administration (FDA).
• Metabolic disorders: May prolong systemic exposure with some drugs (eg, cisplatin, anthracyclines) due to competition for certain multispecific organic anion transporters (MOAT) especially in patients with decreased MOAT activity (eg, Dubin Johnson syndrome).
• Renal impairment: Use with caution in patients with renal impairment. Dose-dependent worsening of renal function or acute renal failure has occurred in patients with renal insufficiency following use of other gadolinium agents, generally within 48 hours following administration. Evaluate renal function in patients with renal impairment prior to use; consider follow-up monitoring.
• Scan interpretation: Certain lesions may not appear with contrast-enhanced scan that do appear with noncontrast imaging; use caution when interpreting.
Signs of hypersensitivity (during and for several hours after procedure); renal function (prior to administration); short- and long-term monitoring of signs and symptoms of NSF (eg, burning, itching, swelling, hardening and/or tightening of skin, joint stiffness, deep hip or rib bone pain, muscle weakness, limited range of motion, and/or yellowed/raised spots on whites of eye)
Gadolinium-based contrast agents cross the placenta; in general, their use in pregnant women is controversial (ACOG 2017). Use should be avoided unless critical for the care of the mother or fetus and it is not prudent to wait until after pregnancy. Agents with a low risk for development of nephrogenic systemic fibrosis should be used at the lowest effective dose (ACR 2015).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea, headache, or sensation of warmth. Have patient report immediately to prescriber signs of nephrogenic systemic fibrosis (skin burning, itching, swelling, or scaling; red or dark spots on the skin; hard or tight skin; stiff joints; muscle weakness; hip or rib pain; or difficulty moving, bending, or straightening arms, hands, legs, or feet), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), abnormal heartbeat, or severe injection site redness, edema, pain or irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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- Drug class: magnetic resonance imaging contrast media
Other brands: Multihance