ProHance® (Gadoteridol)
ProHance® is a macrocyclic, non-ionic gadolinium-based contrast agent, characterized by very low osmolality and viscosity5.
Due mainly to its macrocyclic structure, ProHance® possesses high in vitro stability2,3.
Furthermore, in the latest clinical studies in patients undergoing total hip arthroplasty, it was shown that the retention of gadolinium in bone tissue was significantly higher in patients receiving Omniscan than in those receiving ProHance®: an approximately 2.5-fold higher gadolinium residue was observed in bone tissue of the femoral head after Omniscan than after ProHance® 4,5.
Clinical experience with ProHance® exceeds 15 million doses administered worldwide6.
- ProHance® is a gadolinium-based, macrocyclic, non-ionic MRI contrast agent introduced in 1992. Since its launch, ProHance® has demonstrated a highly significant safety and efficacy record with millions of doses administered worldwide7.
- ProHance® possesses high in vitro stability and has the lowest osmolality of all contrast agents in its class thus accentuating its clinical utility and diagnostic safety2,3,5.
- ProHance® is a non-ionic contrast agent that does not interfere with serum laboratory measurements, including serum calcium determination8.
- ProHance® is characterized by a low dissociation rate and high "in vivo" stability, reducing the risk of exposure to free gadolinium2.
- ProHance® has a low viscosity which may allow for reduced intravascular pressure during high flow injection with an automatic injector5; it also provides optimal injection possibilities due to low osmolality at high injection rates such as in dynamic MR imaging5.
- ProHance® has an extremely stable macrocyclic structure9 and the lowest levels of gadolinium (Gd) deposited in brain tissue in animal experiments and in human studies10,11,12,13. ProHance® has a full line of packaging options, including unique and suitable solutions to optimize dosing protocols, reduce waste and increase operational efficiency.
- ProHance® is the only contrast agent available in 17 ml pre-filled syringes (PFS), offering exceptional dosing versatility and minimizing contrast waste5.
- ProHance® is also supplied in large volumes (available in some markets), increasing dosing flexibility, minimizing contrast waste and simplifying 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.
9) Comparative study of the physicochemical properties of six clinical low molecular weight gadolinium contrast agents.
Laurent S, Elst LV, Muller RN. Contrast Media Mol Imaging. 2006;1(3):128-37
10) Histology and gadolinium distribution in the rodent brain after the administration of cumulative high doses of linear and macrocyclic gadolinium-based contrast agents.
Lohrke J, Frisk AL, Frenzel T, et al. Invest Radiol. 2017;52(6):324-33
11) Differences in gadolinium retention after repeated injections of macrocyclic contrast agents to rats.
Bussi S, Tedoldi F, Maisano F, et al. JMagn Res Imaging. 2017. OI:10.1002/jmri.25822
12) Comparison of Gadolinium Concentrations within Multiple Rat Organs after Intravenous Administration of Linear versus Macrocyclic Gadolinium Chelates.
McDonald RJ, McDonald JS, Dai D, Schroeder D, Jentoft ME, Murray DL, Kadirvel R, Eckel LJ, Kallmes DF. Radiology. 2017 Jun 19:161594. doi: 10.1148/radiol.2017161594. [Epub ahead of print]
13) Macrocyc lic and Other Non-Group 1 Gadolinium Contrast Agents Deposit Low Levels of Gadolinium in Brain and Bone Tissue: Preliminary Results From 9 Patients With Normal Renal Function.
Murata N, Gonzalez-Cuyar LF, Murata K, et al. Invest Radiol. 2016;51(7):447-53
| Summary of Product Characteristics | 07/14/2023 | Download |
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DISCLAIMER
For any type of product, whether drug or device, mentioned on this website, physicians should carefully review the accompanying documentation, instructions or user manual before administering it to the patient to ensure proper use. Data on the characteristics of Bracco Imaging's main products are available online.
RENAL FUNCTION IMPAIRMENT
Cases of Systemic Nephrogenic Fibrosis (NSF) have been reported associated with the use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/min/1.73m2): as there is a possibility of NSF occurring with ProHance®, it should only be used in this type of patients after careful prior evaluation. In patients receiving hemodialysis therapy, hemodialysis may be useful immediately after ProHance® administration to remove residual ProHance® from the body.