MultiHance

GADOBENATE DIMEGLUMINE

Manufacturer: BRACCO DIAGNOSTICS INC

Score: 148.0

Quick Summary

MultiHance is a gadolinium-based contrast agent used for magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients, as well as for magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection. MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents. The most commonly reported adverse reactions are nausea and headache. Special population considerations include use in pregnancy, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

MRI of the CNS in adults and pediatric patients
MRA to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease
Visualization of lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues

Important Safety Information

Warning

Risk associated with intrathecal use and nephrogenic systemic fibrosis

Contraindications

Known allergic or hypersensitivity reactions to gadolinium-based contrast agents

Adverse Reactions

Nausea
Headache
Hypersensitivity reactions
Nephrogenic systemic fibrosis

Dosing Recommendations

General Guidance

No dose adjustment is necessary for pediatric patients 2 years of age and older, but dose adjustments may be necessary for patients with impaired renal function

MRI of the CNS

Adult Dose

0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection

Pediatric Dose

0.1 to 0.2 mL/kg for pediatric patients below 2 years of age

MRA of renal and aorto-ilio-femoral vessels

Adult Dose

0.2 mL/kg (0.1 mmol/kg) administered as a rapid bolus intravenous injection

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

GBCAs cross the placenta and result in fetal exposure and gadolinium retention
Use MultiHance only if imaging is essential and cannot be delayed

Nursing Mothers

Limited literature reports that breastfeeding after gadobenate dimeglumine administration to the mother would result in the infant receiving an oral dose of 0.001%-0.04% of the maternal dose
The developmental and health benefits of breastfeeding should be considered together with the mother's clinical need for MultiHance

Pediatric Use

MultiHance is approved for intravenous use for MRI of the CNS in pediatric patients from birth, including term neonates, to less than 17 years of age
Adverse reactions in pediatric patients were similar to those reported in adults

Geriatric Use

Of the total number of 4967 adult subjects in clinical studies of MultiHance, 33% were 65 or older
No overall differences in safety or effectiveness were observed between these elderly subjects and the younger subjects
The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to MultiHance may be greater in patients with impaired renal function