MULTIHANCE MULTIPACK (gadobenate dimeglumine)
MultiHance is a contrast agent used during imaging procedures of the central nervous system for patients ranging from newborns to adults. It helps clinicians visualize lesions in the brain, spine, and surrounding tissues that exhibit abnormal vascularity or blood-brain barrier issues. The drug is also used in adults to evaluate blood vessels when there is known or suspected occlusive disease in the renal or aorto-ilio-femoral areas.
How MULTIHANCE MULTIPACK Works
This drug works by acting as a paramagnetic agent that develops a magnetic moment when placed within a magnetic field. This process enhances the relaxation rates of nearby water protons, which increases the brightness of the signal in target tissues. By shortening relaxation times, particularly in T1-weighted sequences, it allows for better visualization of both normal and pathological structures.
Details
- Status
- Prescription
- First Approved
- 2004-11-23
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
MULTIHANCE MULTIPACK Approval History
What MULTIHANCE MULTIPACK Treats
3 indicationsMULTIHANCE MULTIPACK is approved for 3 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Abnormal Blood-Brain Barrier
- Abnormal Vascularity
- Aorto-ilio-femoral Occlusive Vascular Disease
MULTIHANCE MULTIPACK Boxed 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 dru...
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 n
MULTIHANCE MULTIPACK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MULTIHANCE MULTIPACK
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04973007 | 19-1045.cc P30CA046934 | Ph 4 | terminated | Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases |
| NCT04373564 ODYSSEY | DGD-44-065 20405, GMRA-105 | Ph 4 | recruiting | Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years |
| NCT04910425 | NU 19U05 NCI-2021-05593, STU00212326 | Ph 2 | withdrawn | PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer |
| NCT03703492 results posted | UW18063 KL2TR000428, NCI-2018-02281 | Ph 2 | completed | Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS |
| NCT02633501 results posted | GDX-44-004 | Ph 2 | completed | P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) |
| NCT01710254 RECAD-AF results posted | REGA-12F08 | Ph 2 | completed | Regadenoson Stress-MRI to Identify Coronary Artery Disease in Atrial Fibrillation Patients |
| NCT01260636 VALUE | MH-137 | Ph 3 | completed | Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MULTIHANCE MULTIPACK FDA Label Details
Indications & Usage
FDA Label (PDF)MULTIHANCE MULTIPACK is indicated for the treatment of Abnormal Blood-Brain Barrier; Abnormal Vascularity; Aorto-ilio-femoral Occlusive Vascular Disease.
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 appro...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.