gadobenate (MultiHance)

Dosing and uses of MultiHance (gadobenate)

• Adult
• Pediatric

 

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%