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Multihance (GADOBENATE DIMEGLUMINE)
Multihance works by enhancing the contrast of MRI images through the paramagnetic properties of gadobenate dimeglumine.
Gadobenate dimeglumine (Multihance), marketed by Bracco, is a contrast agent used primarily for MRI imaging of central nervous system lesions. Its key strength lies in enhancing MRI image contrast through the paramagnetic properties of gadobenate dimeglumine, providing clear visualization of lesions. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | GADOBENATE DIMEGLUMINE |
|---|---|
| Sponsor | Bracco |
| Drug class | gadobenate dimeglumine |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Gadobenate dimeglumine is paramagnetic agent and, as such, developsa magnetic moment when placed in magnetic field. The large magneticmoment produced by the paramagnetic agent results in large localmagnetic field, which can enhance the relaxation rates of water protonsin its vicinity leading to an increase of signal intensity (brightness)of tissue.In magnetic resonanceimaging (MRI), visualization of normal and pathological tissue dependsin part on variations in the radiofrequency signal intensity thatoccur with 1) differences in proton density; 2) differences of thespin-lattice or longitudinal relaxation times (T1); and 3) differencesin the spin-spin or transverse relaxation time (T2). When placed ina magnetic field, gadobenate dimeglumine decreases the T1 and T2 relaxationtime in target tissues. At recommended doses, the effect is observedwith greatest sensitivity in the T1-weighted sequences.
Approved indications
- MRI of CNS Lesions
- MRA of Renal and Aorto-ilio-femoral Vessels
Boxed warnings
- 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 of the drugs. Avoid use of MultiHance in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR <30 mL/min/1.73m 2 ), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see Warnings and Precautions (5.2) ] . WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning 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. (5.1) GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of MultiHance in these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The risk for NSF appears highest among patients with: chronic, severe kidney disease (GFR <30 mL/min/1.73m 2 ), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. (5.2)
Common side effects
- Nausea
- Headache
- Injection Site Reaction
- Feeling Hot
- Vomiting
- Dysgeusia
- Hyperhidrosis
- Paresthesia
- Dizziness
- Serious anaphylactoid reaction
- Convulsions
- Pulmonary edema
Drug interactions
- cisplatin
- doxorubicin
- daunorubicin
- vincristine
- methotrexate
- etoposide
- tamoxifen
- paclitaxel
Key clinical trials
- Cardiac MRI in Measuring the Impact of Anti-androgen Treatment on Cardiac Function in Patients With Prostate Cancer (NA)
- Imaging in MGUS, SMM and MM (PHASE2)
- Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (PHASE4)
- PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer (PHASE2)
- Validity of Parametric MRI Using VIRADS (NA)
- Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis (PHASE2)
- Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases (PHASE4)
- Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Multihance CI brief — competitive landscape report
- Multihance updates RSS · CI watch RSS
- Bracco portfolio CI