Gadopentetic Acid/Gadoversetamide 1587 ble for those receiving medium- or low-risk agents, parti­ has paramagnetic properties and is used as a magnetic cularly patients aged 65 years or older. resonance contrast medium (p. 1580.1). It distributes Adverse Effects and Precautions M RA As for Gadopentetic Acid, p. 1586.2 and p. 1586.2, 1. Perazella A Rodby . Gadolinium-induced nephrogenic systemic mainly into extracellular fluid, but does not cross the blood­ fibrosis in patients with kidney disease. Am J Med 2007; 120: 561-2. brain barrier, and is used in imaging of cranial and spinal respectively. 2. Health Canada. Gadolinium-containing contrast agents and nephro­ structures and of the whole body, and in magnetic genic systemic fibrosis: update. Can Adverse React News 2007; 17 (4): 1-2. Reviews. Also available at: http://www.hc-sc.gc.ca/dhp-mps/alt_fonnats/hpfb­ resonance angiography. 1. Runge VM, Parker JR. Worldwide clinical safety assessment of dgpsa/pdf/medeff/carn-bceLvl7n4-eng.pdf (accessed 25/08110) Gadoteric acid is given intravenously as the meglumine gadoteridol injection: an update. Bur Radiol l997; 7 (suppl 5): 243-5. 3. Mareno-Romero JA, et al. Nephrogenic systemic fibrosis: a case series salt. It is available as a solution containing meglumine suggesting gadolinium as a possible aetiological factor. Br J Dermatol gadoterate 376.9mg/mL (0.5 mmol/mL). The usual dose in Hypersensitivity. For a report of an anaphylactoid reaction 2007; 157: 783-7. 4. Penfield JG, Reilly RF. Nephrogenic systemic fibrosis risk: is there a adults and children is 0.2 mL/kg (0.1 mmol/kg) by with gadoteridol, see under Adverse Effects of Gadopente­ difference between gadolinium-based contrast agents? Semin Dial 200B; intravenous injection. A second dose of up to 0.4 mL/kg tic Acid, p. 1586.2. 21: 129-34. (0.2 mmol/kg) may be given within 30 minutes if necessary. 5. FDA. Gadolinium-containing contrast agents for magnetic resonance For angiography, a dose of 0.1 to 0.2 mL/kg (0.05 to imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and Pharmacokinetics MultiHance (issued 8th June 2006, updated 22nd December, 2006 and 0.1 mmol/kg) may be given, repeated if required. 23rd May, 2007). Available at: http://www.fda.gov/Drugs/DrugSafety/ Gadoteridol is distributed into extracellular fluid after PostmarketDrugSafetylnformationforPatientsandProviders/ intravenous injection. About 94% of a dose is excreted Administration in children. For doses of gadoteric add in ucml42884.htm (accessed 24/08/IO) unchanged in the urine within 24 hours. An elimination children, see Uses and Administration, above. 6. MHRA/CHM. Gadolinium-containing MRI contrast agents: nephrogenic half-life of about 1.57 hours has been reported. systemic fibrosis. Drug Safety Update 2007; 1 (I): 2-3. Available at: http:// www.mhra.gov.uk/home/idcplg?IdcService=GET_Fll.E&dDocName=­ CON203180l&RevisionSelectionMethod=LatestReleased (accessed Adverse Effects and Precautions r ti . .. 14/07/08) �r.�J?.?. �. ��� ...... 7. Health Canada. Association of nephrogenic systemic fibrosis/nephro­ As for Gadopentetic Add, p. 1586.2. Praprietary Preparations (details are given in Volume B) genic fibrosing dermopathy (NSF/NFD) with the use of gadolinium­ containing contrast agents (issued 9th March, 2007). Available at: Single-ingredient Preparations. Austral. : Prohance; Austria: Pro· http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/medeff/ Hypersensitivity. For reports of anaphylactoid reactions hance; Belg.: Prohance; Canad. : ProHance; Cz.: Prohance; gadolinium_nth-aah-eng.pdf (accessed 18/03/09) with gadoterate, see under Adverse Effects of Gadopentetic Denm.: Prohance; Fin.: Prohance; Fr.: Prohance; Ger. : Pro­ 8. Adverse Drug Reactions Advisory Committee (ADRAC). MRI scans with Acid, p. 1586.2. hance; Irl. : Probance; Ita!. : Prohance; Jp n: Prohance; Neth.: gadolinium-containing contrast agents and the risk of nephrogenic systemic fibrosis-caution in patients with renal impairment. Aust Prohance; Norw.: Prohance; Spain: Prohance; Swed.: Prohance; Adverse Drug Read Bull 2008; 17: 2. Also available at: http://www.tga. Switz. : Prohance; UK: Prohance; USA: Prohance. health.gov.au/adr/aadrb/aadr0802.pdf (accessed 18/03/09) Pharmacokinetics 9. MHRA/CHM. Gadolinium-containing contrast agents: new advice to Phannacopaeial Preparations minimise the risk of nephrogenic systemic fibrosis. Drug Safety Update Gadoterate is distributed into the extracellular space after USP 36: Gadoteridol Injection. 2010; 3 (6): 3-5. Available at: http:/lwww.mhra.gov.uk/Publications/ intravenous injection. It is not bound to plasma proteins. A Safetyguidance/DrugSafetyUpdate/CON068297 (accessed 22/03/10) plasma half-life of about 1.5 hours has been reported. It is not metabolised and about 90% of a dose is excreted in the Gadoversetamide (BAN. USAN, r!NNJ Pharmacokinetics urine within 24 hours. Gadopentetate is rapidly distributed into the extracellular space after intravenous injection. An elimination half-life of �.��J?.�.�gadodiamide (see Uses and Administration p. 1585.3), gadoversetarnide may interfere with colori­ metric methods for measuring serum-calcium concentra­ Gadoteridol is a nonionic gadolinium chelate with actions tions. and uses similar to those of gadopentetic add (p. 1586.1). It Gadoversetamide may also interfere with measurement has paramagnetic properties and is used as a magnetic of serum-copper, iron, and zinc concentrations. resonance contrast medium (p. 1580.1). It distributes mainly into extracellular fluid, but does not cross the blood­ Renal impairment. For the view that gadoversetamide brain barrier, and is used in bnaging of cranial and spinal may carry an increased risk of the development of nephro­ structures and of the whole body. genic systemic fibrosis in patients with renal impainnent, Gadoteridol is available as a solution containing see p. 1586.3. 279.3 mg/mL (0.5 mmol/mL). The usual adult dose is 0.2 mL/kg (0.1 mmol/kg) intravenously; for CNS imaging, an additional dose of up to 0.4mL/kg (0.2 mmol/kg) may be Pharmacokinetics given up to 30 minutes after the first if necessary. A single Gadoversetamide is distributed into the extracellular space dose of 0.2 mL/kg (0.1 mmol/kg) is used in children from 6 after intravenous injection. It is not bound to plasma months of age (see also below). proteins. An elimination half-life of about 1.7 hours has been reported. It is not metabolised and about 95.5% of a Administration in children. In some countries, gadoteridol dose is excreted in the urine within 24 hours. is licensed for use in children from 6 months of age; UK Gadoversetamide is removed by haemodialysis. licensed product information notes that experience is lim­ ited in children between 6 months and 2 years of age, and ti advises particular caution if it is to be used in this age �r.�F.r.�. ���············································································ Proprietary Preparations (details are given in Volume B) group. US licensed product information considers that safety and efficacy have not been demonstrated in this age Single-ingredient Preparations. Arg. : Optimark; Austral. : Opti · Uses and Administration group, and only indicates the product for imaging cranial mark; Austria: Optimark; Belg. : Optimark; Canad.: Optimark; Gadoteric add is an ionic gadolinium chelate with actions and spinal structures in those aged 2 years and over. For Cz.: Optimark; Denm.: Optimarkt; Gr.: Optimark; Hung. : Opti­ and uses similar to those of gadopentetic acid (p. 1586.1). It doses see Uses and Administration, above. mark; Irl.: Optimark; Neth.: Optimark; Norw. : Optimark; Pol. :

The symbol t denotes a preparation no longer actively marketed