ProHance® (Gadoteridol)
When Stability Matters 1, 2, 3, 4
ProHance® (gadoteridol) is a macrocyclic, non-ionic molecule chelated to a gadolinium ion, and it has a very low osmolality and viscosity5.
Due primarily to its macrocyclic structure, ProHance® possesses high in vitro stability2, 3.
Moreover, in recent clinical studies in patients undergoing total hip arthroplasty it has been shown that bone tissue retention of gadolinium was significantly higher in patients who received Omniscan than in those who received ProHance®. Approximately 2.5 times more gadolinium remained in femoral head bone after Omniscan than after ProHance® 4, 5.
The clinical experience with ProHance® exceeds 15 million doses administered worldwide6.
ProHance® is a gadolinium based, macrocyclic, non-ionic MR contrast agent first introduced in 1992. Since its launch ProHance® has established a strong record of safety and efficacy with millions of doses administered worldwide7. ProHance® has a high stability and the lowest osmolality among all contrast agents in its class, which maximize clinical utility and diagnostic confidence5.
ProHance® is a non-ionic contrast agent that does not interfere with a number of serum assays, including serum calcium determination8.
ProHance® provides low dissociation rate and high "in vivo" stability, reducing the risk of free gadolinium exposure2.
ProHance® has low viscosity, reducing pressure during high flow rate power injections5; also, it provides optimal injection comfort due to the low osmolality in case of very high rate of injection as in dynamic MR Imaging5.
ProHance® has high stability in virtue of the high chelate strength.
An in vivo study in rodents has shown that ProHance® releases the least amount of Gd in the body compared to gadopentetate, gadodiamide and gadoterate2.
Gibby et al., and White et al., showed that ProHance® leaves up to four times less gadolinium in human bones than gadodiamide3.
ProHance® has a full line of packaging options including unique solutions to optimize dosing protocols, reduce contrast waste, and increase operational efficiencies.
ProHance® is the only contrast agent in a 17 mL Pre Filled-Syringe (PFS) that offers exceptional dosing versatility and minimises contrast waste5.
ProHance® is also provided in large volumes (available in some markets) that increase dosing flexibility, minimise contrast waste and simplify inventory management5.
1) Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review.
Idée JM, Port M, Raynal I, Schaefer M, Le Greneur S, Corot C.Fundam Clin Pharmacol. 2006 Dec;20(6):563-76. Review. Erratum in: Fundam Clin Pharmacol. 2007 Jun;21(3):335.
2) Biodistribution of radiolabeled, formulated gadopentetate, gadoteridol, gadoterate, and gadodiamide in mice and rats.
Tweedle MF, Wedeking P, Kumar K.Invest Radiol. 1995 Jun;30(6):372-80.
3) Comparison of Gd(DTPA-BMA) (Omniscan) versus Gd(HP-DO3A) (ProHance) relative to gadolinium retention in human bone tissue by inductively coupled plasma mass spectroscopy.
White GW, Gibby WA, Tweedle MF.Invest Radiol. 2006 Mar;41(3):272-8.
4) Comparison of Gd DTPA-BMA (Omniscan) versus Gd HP-DO3A (ProHance) retention in human bone tissue by inductively coupled plasma atomic emission spectroscopy.
Gibby WA, Gibby KA, Gibby WA.Invest Radiol. 2004 Mar;39(3):138-42.
5) ProHance® SPC
6) Data on file.
7) Bracco internal data.
8) Gadodiamide administration causes spurious hypocalcemia.
Prince MR, Erel HE, Lent RW, Blumenfeld J, Kent KC, Bush HL, Wang Y. Radiology. 2003 Jun;227(3):639-46.
| ProHance_ PFS_PIL Summary of Products Characteristics_NL_FR | 12/11/2023 | Download | |||
| ProHance_ PFS_ Summary of Products Characteristics_NL_FR | 12/11/2023 | Download | |||
| ProHance_ VIALS_PIL Summary of Products Characteristics_FR | 10/11/2024 | Download | |||
| ProHance_ VIALS_ Summary of Products Characteristics_FR | 10/11/2024 | Download |
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DISCLAIMER
For any product or type of product, whether a drug or device, referenced in this website, physicians should carefully review the product's package insert, instructions for use, or user manual prior to patient administration to ensure proper utilization of the product. The local Summaries of Product Characteristics of the main Bracco Imaging products are available on line.
Impaired renal function
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR <30ml/min/1.73m2). As there is a possibility that NSF may occur with ProHance, it should only be used in these patients after careful consideration. Haemodialysis shortly after ProHance administration in patients currently receiving haemodialysis may be useful at removing Prohance from the body.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.