ProHance® consists of a nonionic gadolinium complex (Gadoteridol) used as a paramagnetic MR contrast agent.
ProHance® provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood brain barrier. ProHance® can also be used for whole body contrast enhanced MRI including the head, neck, liver, breast, musculoskeletal system and soft tissue pathologies.

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m²), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

See Gadoteridol.

The company is a member of the Bracco Group, a highly innovative healthcare group and world leader in global integrated solutions for the diagnostic medical imaging field. The Bracco Group is headquartered in Milan, Italy. Its North American operations consist of Bracco Diagnostics and Bracco Research USA, both located in Princeton, New Jersey. Bracco Diagnostics is one of the fastest growing developers and marketers of diagnostic pharmaceuticals in North America, with products for various imaging applications, including Isovue® (iopamidol - X-ray contrast agent), ProHance® (gadoteridol - MRI contrast agent), SonoVue® (ultrasound contrast agent) and nuclear medicine products.
Gadoteridol has been available in Europe and the USA for several years. Holder of the Marketing Authorization: Bracco International B.V. - Strawinskylaan 3051 - 1077 ZX Amsterdam The Netherlands. (Contact: Kirk Deeter, Phone: +NL-303-838-8708)

MRI Contrast Agents:

Eisai Co., Ltd. (Tokyo, Japan, President: Haruo Naito) and Bracco-Eisai Co., Ltd. (Tokyo, Japan, President: Toshio Matsumoto) decided to withdraw the new drug application (NDA) of E7155 (gadobenate meglumine), since new indications are emerging for the product and additional clinical data was necessary to complete the targeting product competitive risk/benefit profile. The product is currently marketed in other countries, and both companies are discussing a future development plan in Japan.

MRI Contrast Agents:

Radiographic low-osmolar nonionic contrast agents have less side effects and fewer nephrotoxicity than ionic, high-osmolar agents. Gadolinium-based MRI contrast agents have a different formulation from iodinated X-ray contrast media, and there is no known cross sensitivity between these two types of contrast agents. Intravenous MRI contrast agents, specifically the gadolinium chelates have a high safety and lack of nephrotoxicity compared with X-ray contrast media.
The used gadolinium chelates differ in following properties: linear (e.g., gadodiamide and gadoversetamide have nonionic linear structures) vs. macrocyclic cores, and ionic vs. nonionic types. The nonionic molecules have lower osmolality and viscosity, which increase digestibility at greater concentrations, and make faster bolus injections conceivable. The macrocyclic molecules (e.g., gadoteridol has a nonionic macrocyclic ring structure) are more stable and show fewer tendencies to dissociate free Gd.

See also ProHance®, Omniscan®, OptiMARK®, Ionic Intravenous Contrast Agents.

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