References
- LewisGDMalhotraRHernandezAFEffect of oral iron repletion on exercise capacity in patients with heart failure with reduced ejection fraction and iron deficiency: the IRONOUT HF randomized clinical trialJAMA201731719 1958 196628510680
- MartinERSmithMTMaroniBJZurawQCde GomaEMClinical trial of vadadustat in patients with anemia secondary to stage 3 or 4 chronic kidney diseaseAm J Nephrol2017455 380 38828343225
- AvniTBieberAGrossmanAGreenHLeiboviciLGafter-GviliAThe safety of intravenous iron preparations: systematic review and meta-analysisMayo Clin Proc2015901 12 2325572192
- BonovasSFiorinoGAlloccaMIntravenous versus oral iron for the treatment of anemia in inflammatory bowel disease: a systematic review and meta-analysis of randomized controlled trialsMedicine (Baltimore)2016952 e230826765407
- McDonaghTMacdougallICIron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral?Eur J Heart Fail2015173 248 26225639592
- ShepshelovichDRozen-ZviBAvniTGafterUGafter-GviliAIntravenous versus oral iron supplementation for the treatment of anemia in CKD: an updated systematic review and meta-analysisAm J Kidney Dis2016685 677 69027321965
- ShiQLengWWazirRIntravenous iron sucrose versus oral iron in the treatment of pregnancy with iron deficiency anaemia: a systematic reviewGynecol Obstet Invest2015803 170 17825824489
- GeisserPBaerMSchaubEStructure/histotoxicity relationship of parenteral iron preparationsArzneimittelforschung19924212 1439 14521288508
- NeiserSRentschDDipponUPhysico-chemical properties of the new generation IV iron preparations ferumoxytol, iron isomaltoside 1000 and ferric carboxymaltoseBiometals2015284 615 63525801756
- CrommelinDJde VliegerJSWeinsteinVMühlebachSShahVPSchellekensHDifferent pharmaceutical products need similar terminologyAAPS J2014161 11 1424065599
- HussaartsLMühlebachSShahVPEquivalence of complex drug products: advances in and challenges for current regulatory frameworksAnn N Y Acad Sci Epub2017426
- European Medicines AgencyReflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product2015 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184922.pdfAccessed July 5, 2017
- US Food and Drug Administration, 2012Draft guidance on ferumoxytol2012 Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM333051.pdfAccessed July 5, 2017
- US Food and Drug AdministrationDraft guidance on iron sucrose2013 Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM297630.pdfAccessed July 5, 2017
- US Food and Drug AdministrationDraft guidance on ferric carboxymaltose2016 Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM495022.pdfAccessed July 5, 2017
- US Food and Drug AdministrationDraft guidance on iron dextran2016 Available from: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM520240.pdfAccessed July 5, 2017
- US Food and Drug AdministrationFDA tackles drug competition to improve patient access2017 Available from: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm564725.htmAccessed July 5, 2017
- FunkFRyleCCancliniCNeiserSGeisserPThe new generation of intravenous iron: chemistry, pharmacology, and toxicology of ferric carboxymaltoseArzneimittelforschung2010606A 345 35320648926
- JahnMRAndreasenHBFüttererSA comparative study of the physiochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implicationsEur J Pharm Biopharm2011783 480 49121439379
- KeatingGMFerric carboxymaltose: a review of its use in iron deficiencyDrugs2015751 101 12725428711
- RognoniCVenturiniSMeregagliaMMarmiferoMTarriconeREfficacy and safety of ferric carboxymaltose and other formulations in iron-deficient patients: a systematic review and network meta-analysis of randomised controlled trialsClin Drug Invest2016363 177 194
- ToblliJECaoGOliveriLAngerosaMDifferences between original intravenous iron sucrose and iron sucrose similar preparationsArzneimittelforschung2009594 176 19019517894
- ToblliJECaoGOliveriLAngerosaMDifferences between the original iron sucrose complex Venofer and the iron sucrose similar Generis, and potential implicationsPort J Nephrol Hypertens2009231 53 63
- ToblliJECaoGOlivieriLAngerosaMComparison of the renal, cardiovascular and hepatic toxicity data of original intravenous iron compoundsNephrol Dial Transplant20102511 3631 364020488820
- ToblliJECaoGOliveriLAngerosaMComparison of oxidative stress and inflammation induced by different intravenous iron sucrose similar preparations in a rat modelInflamm Allergy Drug Targets2012111 66 7822309085
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseGuideline for elemental impurities: Q3D2014 Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdfAccessed July 5, 2017
- FergelotPRopert-BouchetMAbgueguenEIron overload in mice expressing HFE exclusively in the intestinal villi provides evidence that HFE regulates a functional cross-talk between crypt and villi enterocytesBlood Cells Mol Dis2002283 348 36012367579
- YounPKimSAhnJHKimYParkJDRyuDYRegulation of iron metabolism-related genes in diethylnitrosamine-induced mouse liver tumorsToxicol Lett20091843 151 15819061943
- AkerboomTPSiesHAssay of glutathione, glutathione disulfide, and glutathione mixed disulfides in biological samplesMethods Enzymol198177 373 3827329314
- RossiRCardaioliEScaloniAAmiconiGDi SimplicioPThiol groups in proteins as endogenous reductants to determine glutathione-protein mixed disulphides in biological systemsBiochim Biophys Acta199512432 230 2387873567
- de CavanaghEMInserraFToblliJStellaIFragaCGFerderLEnalapril attenuates oxidative stress in diabetic ratsHypertension2001385 1130 113611711510
- NiehausWGJrSamuelssonBFormation of malonaldehyde from phospholipid arachidonate during microsomal lipid peroxidationEur J Biochem196861 126 1304387188
- ToblliJECaoGOlivieriLAngerosaMComparative study of gastrointestinal tract and liver toxicity of ferrous sulfate, iron amino chelate and iron polymaltose complex in normal ratsPharmacology2008822 127 13718607114
- European Medicines AgencyGuideline on the specification limited for residues of metal catalysts or metal reagents2008 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003586.pdfAccessed July 5, 2017
- ToblliJECaoGOliveriLAngerosaMAssessment of the extent of oxidative stress induced by intravenous ferumoxytol, ferric carboxymaltose, iron sucrose and iron dextran in a nonclinical modelArzneimittelforschung2011617 399 41021899208
- ToblliJECaoGGianiJFDominiciFPAngerosaMNitrosative stress and apoptosis by intravenous ferumoxytol, iron isomaltoside 1000, iron dextran, iron sucrose, and ferric carboxymaltose in a nonclinical modelDrug Res2015657 354 360
- ToblliJECaoGAngerosaMThe induction of oxidative/nitrosative stress, inflammation, and apoptosis by a ferric carboxymaltose copy compared to iron sucrose in a non-clinical modelJ Clin Diagn Res2015912 FF8 FF12
- Martin-MaloAMerinoACarracedoJEffects of intravenous iron on mononuclear cells during the haemodialysis sessionNephrol Dial Transplant2012276 2465 247122207322
- LeeESParkBRKimJSChoiGYLeeJJLeeISComparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patientsCurr Med Res Opin2013292 141 14723252876
- SteinJDignassAChowKUClinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originatorCurr Med Res Opin2012282 241 24322181342
- RottembourgJKadriALeonardEDansaertALafumaADo two intravenous iron sucrose preparations have the same efficacy?Nephrol Dial Transplant2011261 3262 326721355067
- MuñozMGarcia-ErceJARemachaAFDisorders of iron metabolism – part I: molecular basis of iron homeostasisJ Clin Pathol2011644 281 28621177266
- ZagerRAParenteral iron compounds: potent oxidants but mainstays of anemia management in chronic renal diseaseClin J Am Soc Nephrol20061Suppl 1 S24 S3117699373
- ToblliJECaoGOliveriLAngerosaMEvaluation of toxicity and oxidative stress induced by intravenous iron isomaltoside 1000 in a nonclinical modelArzneimittelforschung2011611 553 56522164963
- PreusserLCFryerRMGerhardtAEffects of intravenous ABT-870 (iron (III)-hydroxide oligosaccharide) on mean arterial pressure and heart rate in the anaesthetized beagle: comparison with other iron-containing haematinic agentsClin Exp Pharmacol Physiol20053212 1020 102616445566
- DiesenDLKuoPCNitric oxide and redox regulation in the liver – part II: redox biology in pathologic hepatocytes and implications for interventionJ Surg Res20111671 96 11220400112
- RamaiahSKA toxicologist guide to the diagnostic interpretation of hepatic biochemical parametersFood Chem Toxicol2007459 1551 155717658209
- ThévenodFWolffNAIron transport in the kidney: implications for physiology and cadmium nephrotoxicityMetallomics201681 17 4226485516
- KudoHSuzukiSWatanabeAKikuchiHSassaSSakamotoSEffects of colloidal iron overload on renal and hepatic siderosis and the femur in female ratsToxicology20082462–3 143 14718289763
- IshiyamaAAtarashiKMinamiMRole of free radicals in the pathogenesis of lipid-induced glomerulosclerosis in ratsKidney Int1999554 1348 135810200999
- Ferinject [summary of product characteristics]BernVifor Pharma2017