MALTOSE FACTS - Octagam

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MALTOSEFACTSMaltose1-5Maltose and other sugars, such as icodextrin, galactose, and xylose, may be found in somebiologic therapies and other products (see Table 1). When infused intravenously, maltoseis converted to glucose in the kidney and metabolized. However, intravenous maltose doesnot significantly affect serum glucose or insulin levels, and can be safely administered todiabetic patients.Maltose and Blood Glucose MonitoringSystems1,2Certain blood glucose monitoring systems (BGMS) falsely interpret maltose, icodextrin,galactose, and xylose as glucose and can result in potentially falsely elevated glucose readings.If insulin is administered as a result of these false readings, hypoglycemia can occur. The BGMSthat utilize test strips containing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ)and glucose-dye-oxidoreductase (GDO) can result in this interference. This interference isnot limited to maltose.

MALTOSEFACTSProducts Exhibiting Interference With Some BGMSTable 1. Description of products and substances containing maltose, icodextrin, galactose, or xylose1,2SUBSTANCE*USECOMMENTSBexxar Chemotherapeutic agentContains maltoseHepaGam B Hepatitis B prophylaxisContains maltoseOrencia Treatment of rheumatoid arthritisContains maltoseVaccinia ImmuneGlobulin Treatment of adversereactions to smallpox vaccineContains maltoseWinRho SDF Treatment of idiopathicthrombocytopenic purpuraContains maltoseIcodextrinExtraneal peritoneal dialysis solutionADEPT adhesion reduction solutionIcodextrin is metabolizedto maltoseGalactoseAdministered orally or intravenouslyas a galactose tolerance test todetermine the liver’s ability toconvert galactose to glycogenPromoted in health food stores for a widerange of illnesses and promotedas safe for use in diabetic patientsXyloseAdministered orally to determine ifintestinal malabsorption is presentPromoted in health food stores for a widerange of illnesses and promotedas safe for use in diabetic patientsOctagam [Immune GlobulinIntravenous (Human)] 5%liquid preparationFor the treatment of primary humoralimmunodeficiency (PI)Contains maltose (100 mg maltose/mLin 50 mg IgG/mL [ie, 2 g maltoseper 1 g IgG/Octagam ])Octagam [Immune GlobulinIntravenous (Human)] 10%liquid preparationFor the treatment of immunethrombocytopenic purpura (ITP)in adultsContains maltose (90 mg maltose/mLin 100 mg IgG/mL [ie, 0.9 gmaltose per 1 g IgG/Octagam ])Table 1 is a non-comprehensive list; substances and uses are current as of March 2016.*Refer to manufacturer’s product prescribing information for additional information.How to Prevent This Interference2The FDA recommends that clinicians avoid using GDH-PQQ glucose test strips in healthcare facilities. Or if the facility currently usesGDH-PQQ glucose test strips, they should NEVER be used on patients who are receiving interfering products, or on patients where itis not known if they are using interfering productsConsult the package inserts for BGMS and products containing maltose, icodextrin, galactose, and xylose, and educate patients andclinicians regarding this interferenceScreen ALL diabetic patients who are using the glucometers listed in Table 2 for the use of maltose-containing products,icodextrin, galactose, and xyloseWARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILUREPlease see Octagam 5% and Octagam 10% Full Prescribing Information for complete Boxed Warnings and additional important information.Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam 5% and Octagam 10% liquidpreparations. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous orarterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with IGIV products, includingOctagam 5% and Octagam 10% liquid preparations. Renal dysfunction and acute renal failure occur more commonly with IGIV productscontaining sucrose. Octagam 5% and Octagam 10% liquid preparations do not contain sucrose.For patients at risk of thrombosis, renal dysfunction, or acute renal failure administer Octagam 5% or Octagam 10% liquid preparations at theminimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms ofthrombosis and assess blood viscosity in patients at risk for hyperviscosity.FDA, US Food and Drug Administration; IgG, immunoglobulin G.Please see accompanying Full Prescribing Information for additional important information.

MALTOSEFACTSBlood glucose monitoring systems that CAN be usedon patients receiving products containing maltose,icodextrin, galactose, or xylose3Table 2.MANUFACTURER &GLUCOMETERENZYME UTILIZEDIN TEST STRIPSAbbott Diabetes Care (Alameda, CA)MANUFACTURER &GLUCOMETERENZYME UTILIZEDIN TEST STRIPSAbbott Diabetes Care (continued)BootsGDH-NADPrecision Xceed ProGDH-NADFreeStyle FlashGDH-NADPrecision XtraGDH-NADFreeStyle FreedomGDH-NADPrecision Xtra OK*GDH-NAD, GOFreeStyle Freedom LiteGDH-NADReliOn UltimaGDH-NADFreeStyle InsuLinxGDH-FADTrueSenseGDH-NADFreeStyle LiteGDH-NADFreeStyle MiniGDH-NADiBGSTGOFreeStyle OptiumGDH-NADJazzGOFreeStyle Optium HGDH-NADJazz WirelessGOFreeStyle Optium NeoGDH-NADPrestoGOFreeStyle Optium Neo HGDH-NADFreeStyle Papillon InsuLinxGDH-FADFreeStyle Papillon LiteGDH-NADFreeStyle Papillon MiniGDH-NADFreeStyle Papillon VisionGDH-NADFreeStyle PrecisionGDH-NADFreeStyle Precision HGDH-NADFreeStyle Precision NeoGDH-NADFreeStyle Precision ProGDH-NADOmron HEA-214GDH-NADOptiumGDH-NADAgaMatrix, Inc. (Salem, NH)Arkray, Inc. (Edina, MN)Assure PlatinumGOAssure PrismGOGLUCOCARD 01GOGLUCOCARD 01-miniGOGLUCOCARD 01-mini plusGOGLUCOCARD ExpressionGOGlucoCard G BlackGDH-FADGlucoCard MXGDH-FADGLUCOCARD MyDIAGOOptium EasyGDH-NADGlucoCard PrismGOOptiumEZGDH-NADGlucoCard SGDH-FADOptium XceedGDH-NADGlucoCard ShineGOOptium XidoGDH-NADGLUCOCARD ΣGOOptium Xido NeoGDH-NADGLUCOCARD Σ-miniGOPrecision XceedGDH-NADGlucoCard SMGDH-FAD†Important InformationThis is a non-comprehensive list, current as of November 2016. Absence of a specific glucose monitor or test strips from this listdoes NOT imply compatibility or incompatibility with products that contain maltose, isodextrin, glactose, or xylose. Similarly, otherglucose-measuring technologies that are not listed (such as continuous glucose monitoring systems) may or may not be compatiblewith these solutions.Always contact the device manufacturer for current information. If the manufacturer cannot provide informationregarding compatibility of the device with solutions containing maltose, isodextrin, glactose, or xylose, it is NOTrecommended that patients use the product. Octapharma reserves the right to change this list without notice and doesnot represent that it includes all compatible or potentially incompatible products. While efforts have been made toprovide accurate and current information, Octapharma does not manufacture these glucose monitors or test stripsand thus does not guarantee the initial or continued accuracy of this information. Please contact the manufacturer(s)of the glucose monitor and test strip to obtain the latest compatibility information.

MALTOSEFACTSBlood glucose monitoring systems that CAN be usedon patients receiving products containing maltose,icodextrin, galactose, or xylose3cont'dTable 2.MANUFACTURER &GLUCOMETERENZYME UTILIZEDIN TEST STRIPSArkray, Inc. (continued)MANUFACTURER &GLUCOMETERENZYME UTILIZEDIN TEST STRIPSLifeScan, Inc. (Milpitas, CA)GlucoCard X-mini plusGDH-FADOneTouch InDuoGOGLUCOCARD X-meterGDH-FADOneTouch PingGOGLUCOCARD X-mini‡GDH-FADOneTouch SelectGOGLUCOCARD X-mini plus‡GDH-FADOneTouch Select MiniGOGLUCOCARD VitalGOReliOn ConfirmGOOneTouch SelectPlusGOReliOn MicroGOOneTouch SelectPlus FlexGOReliOn PrimeGOOneTouch Select SimpleGOOneTouch SureStepGOOneTouch UltrallGOOneTouch Ultra 2GOOneTouch UltraEasyGOOneTouch UltraLinkGOOneTouch UltraMiniGOOneTouch UltraSmartGOOneTouch UltraVueGOOneTouch VerioGDH-FADOneTouch VerioFlexGDH-FAD‡‡Ascensia Diabetes Care (formerly Bayer Healthcare,Basel, Switzerland)Ascensia BrioGOAscensia EntrustGOBreeze 2GOContourGDH-FADContour LinkGDH-FADContour NextGDH-FADContour Next EZGDH-FADContour Next LinkGDH-FADContour Next Link 2.4GDH-FADContour Next USBGDH-FADOneTouch VerioIQGDH-FADContour PlusGDH-FADOneTouch VerioProGDH-FADContour TSGDH-FADOneTouch VerioPro GDH-FADContour USBGDH-FADOneTouch VerioSyncGDH-FADContour XTGDH-FADOneTouch VerioVueGDH-FADEliteGOOneTouch VitaGOGOSureStep FlexxGO§Elite XLGDH-FAD, glucose dehydrogenase flavin adenine dinucleotide; GDH-NAD, glucose dehydrogenase nicotine adenine dinucleotide; GO, glucose oxidase. Mut Q-GDH,glucose dehydrogenase with pyrroloquinolinequinone modified to eliminate maltose interference.Always contact the device manufacturer for current information. If the manufacturer cannot provide informationregarding compatibility of the device with solutions containing maltose, isodextrin, glactose, or xylose, it is NOTrecommended that patients use the product. Octapharma reserves the right to change this list without notice anddoes not represent that it includes all compatible or potentially incompatible products.*Two types of compatible test strips for Precision Xtra OK.†This/These monitor/test strips were not currently certified as having been tested to Baxter’s recommended interference limits for maltose or icodextrin when this List was issued.Consult manufacturer for additional information.‡These Arkray monitors/test strips have switched from an incompatible GDH-FAD–based chemistry to a compatible GDH-FAD–based chemistry. Consult manufacturer for additional information.§Baxter report REP-NIV-RE-366 Evaluation of potential interference in blood glucose determination (measured with enzymatic methods) for patients treated with icodextrin.IIBaxter report Interim 1, 33541 Determination of potential interference of icodextrin and its metabolites on human blood glucose measurement using chosen glucometers.¶The Accu-Chek Nano (not Aviva or Performa) and Accu-Chek Aviva Plus glucose systems are available within the United States ONLY, and use test strips branded as Accu-Chek Smartviewand Accu-Chek Aviva Plus, respectively. These systems use the Mut Q-GDH (compatible) strips. Consult manufacturer for additional information.

MALTOSEFACTSBlood glucose monitoring systems that CAN be usedon patients receiving products containing maltose,icodextrin, galactose, or xylose3cont'dTable 2.MANUFACTURER &GLUCOMETERENZYME UTILIZEDIN TEST STRIPSNova Biomedical (Waltham, MA)MANUFACTURER &GLUCOMETERENZYME UTILIZEDIN TEST STRIPSRoche Diagnostics (continued)Accu-Chek Aviva NanoMut Q-GDHAccu-Check Aviva Plus¶Mut Q-GDHAccu-Chek Inform IIMut Q-GDHGDG-FADAccu-Chek MobileMut Q-GDHGOAccu-Chek Nano¶Mut Q-GDHAccu-Chek Nano SmartView¶Mut Q-GDHAccu-Chek PerformaMut Q-GDHNova Max LinkGONova Max PlusGONova Pro Glucose/KetoneMeterStatStrip HospitalGlucose MeterStatStrip Hospital GlucoseandKetone Monitoring SystemGOStatStrip XpressGOAccu-Chek Performa ComboMut Q-GDHStatStrip Xpress Glucose andKetone Monitoring SystemGOAccu-Chek PerformaConnectMut Q-GDHAccu-Chek Performa InsightMut Q-GDHProdigy Diabetes Care (Charlotte, NC)Prodigy AutoCode†GOAccu-Chek Performa NanoMut Q-GDHProdigy No Coding TestStrips†GOAccu-Chek VoicematePlus SystemMut Q-GDHProdigy Pocket†GOProdigy Voice†GORoche Diagnostics (Basel, Switzerland)Accu-Chek ActiveMut Q-GDHAccu-Chek AvivaMut Q-GDHAccu-Chek Aviva ComboMut Q-GDHAccu-Chek AvivaCompact PlusMut Q-GDHAccu-Chek Aviva ConnectMut Q-GDHAccu-Chek Aviva ExpertMut Q-GDHAccu-Chek Aviva InsightMut Q-GDHTrividia Health (formerly Nipro Diagnostics, Inc.,Fort Lauderdale, FL)TRUE METRIX-ProGDH-FADTRUE METRIX-AirGDH-FADTRUE METRIX-GoGDH-FADImportant InformationThis is a non-comprehensive list, current as of November 2016. Absence of a specific glucose monitor or test strips from this listdoes NOT imply compatibility or incompatibility with products that contain maltose, isodextrin, glactose, or xylose. Similarly, otherglucose-measuring technologies that are not listed (such as continuous glucose monitoring systems) may or may not be compatiblewith these solutions.Always contact the device manufacturer for current information. If the manufacturer cannot provide informationregarding compatibility of the device with solutions containing maltose, isodextrin, glactose, or xylose, it is NOTrecommended that patients use the product. Octapharma reserves the right to change this list without notice and doesnot represent that it includes all compatible or potentially incompatible products. While efforts have been made toprovide accurate and current information, Octapharma does not manufacture these glucose monitors or test stripsand thus does not guarantee the initial or continued accuracy of this information. Please contact the manufacturer(s)of the glucose monitor and test strip to obtain the latest compatibility information.

MALTOSEFACTSFor more information, please contact us:Octapharma USA, Inc.121 River Street, Suite 1201Hoboken, NJ 07030Tel: 201-604-1130www.octapharma.usCustomer Service:uscustomerservice@octapharma.comTel: ma.comTel: 800-554-4440 Fax: 800-554-6744Medical Affairs:usmedicalaffairs@octapharma.comTel: 888-429-4535For all inquiries relating to drug safety, or to report adverse events please contact our localDrug Safety Officer:Office: 201-604-1137 Cell: 201-772-4546 Fax: 201-604-1141or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.References: 1. DOF. Blood Glucose Monitoring Systems (BGMS) and Sugar interference. Octapharma, Inc. 2. FDA public health notification: potentially fatal errors with GDH-PQQ glucose monitoringtechnology, July 2014. Available at: http://www.fda. ealthnotifications/ucm176992.htm. Accessed July 2014. 3. Schleis T. Pharmacotherapy.2007;27:1313-1321. 4. Young et al. J Clin Invest. 1971;50:986-991. 5. Toyota et al. Tohoku J Exp Med. 1974;114:61-69. 6. Country-specific glucose monitoring list, March 2016.Available at: tor%20list%20US.pdf. Accessed October 2016.Important InformationIt is the responsibility of clinicians and patients to review the package insert of all test strips to determine the type of glucose testingsystem that is used, and use only those systems that utilize the glucose oxidase (GO), glucose dehydrogenase nicotine adeninedinucleotide (GDH-NAD), glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD), or the glucose dehydrogenase withpyrroloquinolinequinone modified to eliminate maltose interference (Mut Q-GDH) methods of enzymes in their test strips whenreceiving products that contain maltose, icodextrin, galactose, or xylose. Blood glucose monitoring systems that cause falselyelevated glucose reading in the presence of maltose, icodextrin, galactose, or xylose are those systems that utilize theGDH-PQQ or GDO enzymes in their test strips.This list is compiled from a search via: Internet, literature, Baxter internal studies, information from government agencies, test stripleaflets, safety alerts, and direct information from the product manufacturers. While efforts have been made to provide accurate andcurrent information, Octapharma does not manufacture these glucose monitors or test strips and thus does not guarantee the initialor continued accuracy of this information. Please contact the manufacturer(s) of the glucose monitor and test strip to obtain the latestcompatibility information.Please see accompanying Full Prescribing Information for additional important information. 2017. Octapharma USA Inc. All rights reserved.Date of preparation: 1/2017. IMNU-0106-PSA

The Accu-Chek Nano (not Aviva or Performa) and Accu-Chek Aviva Plus glucose systems are available within the United States ONLY, and use test strips branded as Accu-Chek Smartview and Accu-Chek Aviva Plus, respectively. These systems use the Mut Q-GDH (compatible)

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