gadobenate (MultiHance)
Classes: Gadolinium-Containing Contrast Agents; Contrast Media, Nonionic/ High Osmolality
Dosing and uses of MultiHance (gadobenate)
Adult dosage forms and strengths
intravenous solution
- 529mg/mL
CNS Imaging
MRI contrast agent indicated for CNS imaging to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues
0.1 mmol/kg (0.2 mL/kg) rapid IV bolus; follow by saline flush of at least 5 mL
Renal & Aorto-Ilio-Femoral Vessel Imaging
For use in magnetic resonance angiography to evaluate renal or aorto-ilio-femoral occlusive vascular disease
0.1 mmol/kg (0.2 mL/kg) rapid IV bolus; follow by saline flush of at least 20 mL
Pediatric dosage forms and strengths
intravenous solution
- 529mg/mL
CNS Imagining
MRI contrast agent indicated for CNS imaging to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues
<2 years: Safety and efficacy not established
2 years or older: 0.1 mmol/kg (0.2 mL/kg) rapid IV bolus; follow by saline flush of at least 5 mL
Warnings
Black box warnings
Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73 sq.m), hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant
NSF affects internal organs, skin, and muscle and can be fataL
Only use if essential and MRI cannot provide appropriate diagnostic image
Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses
Contraindications
Hypersensitivity; known allergy to gadolinium or formulation components
Cautions
History of asthma/allergy/drug reactions or hypersensitivity-like disorders
Risk of anaphylactoid reaction
Risk for nephrogenic systemic fibrosis (NSF) in patients w/ acute or chronic severe renal insufficiency, hepatorenal syndrome or in perioperative liver transplantation period
Screen patients for kidney disease before use and monitor renal function afterward; nephrogenic systemic fibrosis (NSF) associated with use of gadolinium contrast media in patients with kidney disease
Anemia, hepatic/renal impairment, hemoglobinopathies, thrombotic syndromes
Risk of hypotension/hypertension
Patients with or using medication for metabolic, cardiac, or other abnormalities predisposing to cardiac arrhythmias
Cardiac arrhythmias reported; use caution in patients with predisposing proarrhythmic conditions or that are taking proarrhythmic drug therapy concurrently
May prolong systemic exposure in patients with decreased multispecific organic anion transporters
Local tissue damage may occur in extravasation
Brain deposits
- 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
- Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
- It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
- Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of MultiHance (gadobenate)
Mechanism of action
Gadolinium-containing paramagnetic agent that when exposed to an external magnetic field induces a large local magnetic field in exposed tissues. The local magnetism changes proton density and spin characteristics that can be detected in the imaging device
Pharmacokinetics
Vd: 0.17-0.282 L/kg; does not cross intact blood brain barrier
Half-life: 1-2 hr (normal renal function); 6 hr (CrCl 30-60 mL/min); 9.5 hr (10-30 mL/min); 42 hr (end-stage renal disease)
Excretion: Urine 78-96%; feces 0.4-0.6%