EC12-075(T) Rev 1 Dox M1 brochure.pdf - Biocompatibles

Expanding thehorizon of DC Bead ® ......to give more patientsmore treatment optionsDC Bead M1 for loadingwith doxorubicinBiocompatiblesExcellence inInterventional Oncology

DC Bead M1 for loading with doxorubicin...• DC Bead M1 may allow for more concentrated drug delivery within the tumourand greater tumoural devascularisation ¹• DC Bead M1 may allow the physician to be selective and target only the vesselsfeeding the tumour, therefore avoiding proximal occlusion, which may inducehypoxia in non-targeted tissue 2,3• DC Bead M1 may allow the physician to undertake more selective embolisation,saving healthy liver and reducing stress to cirrhotic liver ¹In-vivo doxorubicin concentration DC Bead M1 vs DC Bead ® 100-300µm 41400p = 0.112001000DC Bead M1 loadedwith doxorubicinDC Bead 100-300µmloaded with doxorubicinp = 0.05800nM6004002000Tumour coreTumour peripheryp = 0.005Overall, mean tumour doxorubicin concentration in the DC Bead M1 (70-150µm)group was significantly higher than in the DC Bead 100-300µm group (p=0.005). 4...to give more patientsmore treatment options

DC Bead M1 Ordering InformationNominal Bead Size Volume of Beads Product Code70-150µm2mlDC2V001Loading times for up to 37.5mg of doxorubicin per ml of DC Bead M1 (75mg per vial)Doxorubicin uptakeTime90%* 30 minutes98%* 60 minutes* Tolerance of ±3%DC Bead M1 Indications• DC Bead M1 is primarily intended as an embolic agent for the treatmentof malignant hypervascularised tumour(s)• DC Bead M1 is compatible with irinotecan, which can be loaded prior toembolisation and then, as a secondary action, elute a local, controlledand sustained dose to the mCRC after embolisation• DC Bead M1 is compatible with doxorubicin, which can be loaded prior toembolisation and then, as a secondary action, elute a local, controlledand sustained dose to the tumour after embolisationDC Bead M1 is not currently cleared by the FDA for sale or distributionin the USA.Important InformationCautions: DC Bead M1• Embolisation DC Bead M1 should only be performed by a physician with appropriateinterventional occlusion training in the region intended to be embolised• Do not use if the vial or packaging appear damaged• Ensure that DC Bead M1 is an appropriate size for the intended vasculature• Consider upsizing to a larger size of DC Bead ® in the presence of AV shunts or ifangiographic evidence of embolisation does not appear quickly during delivery• Consideration should be given to Tc99m-MAA scanning if there is suspicionof AV shuntingCautions: Irinotecan-loaded DC Bead M1• On addition of non-ionic contrast/water mixture to irinotecan-loaded beads,some irinotecan will be eluted over time. If the beads are not used immediately,up to 10mg irinotecan may be present in the contrast/water mixture. If this occurs,a small dose of irinotecan may be available systemically at time of delivery• Do not use irinotecan-loaded beads with contrast agents containing salts(e.g. Calcium chloride)• The maximum amount of irinotecan that can be loaded is 100mg irinotecanper 2ml vial of DC Bead M1. . Exceeding this amount may lead to some irinotecanremaining free in solution. This free solution should be removed prior to useto prevent the patient receiving the excess dose as a bolusCautions: Doxorubicin-loaded DC Bead M1• Exceeding a loading dose of 37.5mg doxorubicin per 1ml DC Bead M1 maylead to some systemic distribution of doxorubicin and related side effectsPotential Complications: DC Bead M1• Undesirable reflux or passage of DC Bead M1 into normal arteries adjacent tothe targeted lesion or through the lesion into other arteries or arterial beds• Non-target embolisation• Pulmonary embolisation• Ischaemia at an undesirable location• Capillary bed saturation and tissue damage• Ischaemic stroke or ischaemic infarction• Vessel or lesion rupture and haemorrhage• Neurological deficits including cranial nerve palsies• Vasospasm• Death• Recanalisation• Foreign body reactions necessitating medical intervention• Infection necessitating medical intervention• Clot formation at the tip of the catheter and subsequent dislodgementWARNING: Studies have shown that DC Bead M1 do not form aggregates and,as a result, penetrate deeper into the vasculature as compared to similarlysized PVA particles.For instructions for use, please refer to:www.biocompatibles.com/dcbead-m1-ifuReferences:1. Geschwind J et al. Doxorubicin Eluting Bead Sizes 100-300µm and 70-150µm in the VX2 Model.Presented at ECIO 2012 (Terumo Symposium).2. Lee K et al. Distribution of Iron-Oxide containing Embosphere Particles after Transcatheter ArterialEmbolization in an Animal Model of Liver Cancer: Evaluation with MR Imaging and Implication for Therapy.J Vasc Interv Radiol 2008; 19: 1490 –1496.3. Kim KR et al. Hypoxia-induced angiogenesis in human hepatocellular carcinoma.J Mol Med (2002) 80; 703-714.4. Data on file at Biocompatibles UK Ltd.5. Dreher MR et al. Radiopaque drug-eluting beads for transcatheter embolotherapy:experimental study of drug penetration and coverage in swine.J Vasc Interv Radiol. 2012 Feb; 23(2): 257-64.DC Bead and DC Bead M1 are manufactured by Biocompatibles UK Ltd, Chapman House,Farnham Business Park, Weydon Lane, Farnham, Surrey, GU9 8QL, UK.DC Bead and DC Bead M1 are distributed in Europe by Terumo (www.terumo-europe.com).DC Bead is a registered trademark and DC Bead M1 is a trademark of Biocompatibles UK Ltd.Biocompatibles UK Ltd is a BTG International group company. BTG and the BTG roundel logoare registered trademarks of BTG International Ltd.© Copyright 2012 Biocompatibles UK Ltd. EC12-075(T) Rev 1.BiocompatiblesExcellence inInterventional Oncology