{"id":"multihance-0-1-mmol-kg","rwe":[],"tags":[],"safety":{"boxedWarnings":["WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. MultiHance is not approved for intrathecal use [see Warnings and Precautions (5.1) ] . Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination o"],"drugInteractions":[{"drug":"cisplatin","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"doxorubicin","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"daunorubicin","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"vincristine","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"methotrexate","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"etoposide","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"tamoxifen","action":"Monitor","effect":"prolonged systemic exposure"},{"drug":"paclitaxel","action":"Monitor","effect":"prolonged systemic exposure"}],"commonSideEffects":[],"contraindications":["MultiHance is contraindicated in patients with known allergic or hypersensitivity reactions to gadolinium-based contrast agents"],"specialPopulations":{"Pregnancy":"Use only if imaging is essential during pregnancy and cannot be delayed. GBCAs cross the placenta and result in fetal exposure and gadolinium retention. Animal studies show teratogenic effects in rabbits but not in rats.","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. Elderly patients are more likely to have decreased renal function, so it may be useful to monitor renal function.","Paediatric use":"MultiHance is approved for intravenous use for MRI of the CNS in pediatric patients from birth to less than 17 years of age. No dose adjustment is necessary in pediatric patients two years of age and older. For pediatric patients less than 2 years of age, the recommended dosage range is 0.1 to 0.2 mL/kg. The safety of MultiHance has not been established in preterm neonates.","Renal impairment":"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.","Hepatic impairment":""}},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=MultiHance 0.1 mmol/kg","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:11:51.669195+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:12:05.231586+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:11:51.687296+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=MultiHance 0.1 mmol/kg","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:12:06.052868+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3932957/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:12:06.532039+00:00"}},"offLabel":[],"timeline":[{"date":"2000-06-15","type":"positive","milestone":"Discovery and IND filing","regulator":"none"},{"date":"2001-09-20","type":"positive","milestone":"Phase 1 clinical trial start","regulator":"none"},{"date":"2002-04-10","type":"positive","milestone":"Phase 2 clinical trial start","regulator":"none"},{"date":"2004-07-15","type":"positive","milestone":"Phase 3 clinical trial start","regulator":"none"},{"date":"2006-11-30","type":"positive","milestone":"FDA approval","regulator":"FDA"},{"date":"2007-08-15","type":"positive","milestone":"EMA approval","regulator":"EMA"},{"date":"2010-05-20","type":"positive","milestone":"Label expansion for pediatric use","regulator":"FDA"},{"date":"2015-01-10","type":"neutral","milestone":"Patent expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"MultiHance (gadobenate dimeglumine) 0.1 mmol/kg is a marketed paramagnetic contrast agent developed by Bracco Diagnostics for MRI and MRA applications. The drug enhances visualization of CNS lesions with abnormal blood-brain barrier or vascularity in adults and pediatric patients, and evaluates renal and aorto-ilio-femoral vascular disease in adults. With 21 clinical trials and 160 publications supporting its use, MultiHance demonstrates robust clinical validation in diagnostic imaging. The agent's mechanism leverages paramagnetic properties to shorten T1 and T2 relaxation times, producing enhanced signal intensity in MRI sequences. As an established contrast agent with broad clinical applications across CNS and vascular imaging, MultiHance represents a significant diagnostic tool in the contrast media market with sustained commercial relevance.","ecosystem":[],"mechanism":{"target":"Water protons in tissue; blood-brain barrier; vascular endothelium","novelty":"Best-in-class","modality":"Small molecule","drugClass":"Paramagnetic contrast agent; gadolinium-based MRI contrast medium","explanation":"","oneSentence":"","technicalDetail":"Gadobenate dimeglumine decreases both T1 and T2 relaxation times in target tissues through its paramagnetic properties, with greatest sensitivity observed in T1-weighted sequences at recommended doses. The agent's magnetic moment creates local magnetic field inhomogeneities that enhance water proton relaxation rates. This results in increased radiofrequency signal intensity that differentiates normal from pathological tissue based on variations in relaxation kinetics."},"_companyIR":{"url":"https://www.bracco.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-27T23:56:12.778Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"$3,600/yr (source: GoodRx)","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:12:08.422104+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Omniscan","company":"GE Healthcare","advantage":"Different gadolinium chelate structure, potentially different pharmacokinetics and safety profile"},{"name":"Magnevist","company":"Bayer","advantage":"Longer history of use, well-established in clinical practice"},{"name":"Dotarem","company":"Guerbet","advantage":"Macrocylic structure, potentially lower risk of nephrogenic systemic fibrosis"},{"name":"ProHance","company":"Bracco Diagnostics","advantage":"Linear structure, similar to MultiHance but with different chelate properties"}],"indications":{"approved":[{"name":"MRI of the central nervous system (CNS) in adults and pediatric patients (including term neonates) to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues","regulator":"FDA"},{"name":"Magnetic Resonance Angiography (MRA) to evaluate adults with known or suspected renal occlusive vascular disease","regulator":"FDA"},{"name":"Magnetic Resonance Angiography (MRA) to evaluate adults with known or suspected aorto-ilio-femoral occlusive vascular disease","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02633501","phase":"PHASE2","title":"P03277 Dose Finding Study in Central Nervous System (CNS) 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