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WARNING

Potential for Incorrect Blood Glucose Reading

Patients using Polithera (icodextrin) peritoneal dialysis solution may have incorrect blood glucose results when using particular blood glucose monitors or test strips.

ONLY use glucose-specific monitors and test strips.  These methods are common in clinical laboratories. 

The term "glucose-specific" applies to monitors or test strips that are not affected by the presence of maltose or certain other sugars [1-4]. Because Polithera (icodextrin) peritoneal dialysis solution results in elevated blood levels of maltose [1], only glucose-specific monitors and test strips should be used.

DO NOT USE monitors or test strips that use glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) [5-6], whereas the use of a mutant variant of GDH-PQQ (Mut Q-GDH) seems to eliminate maltose interference [7-8].

These methods may lead to falsely elevated blood glucose readings in patients using Polithera (icodextrin) due to maltose interference.  Falsely elevated blood glucose readings may mask true hypoglycemia or lead to the erroneous diagnosis of hyperglycemia, leading to life-threatening events [4-5].

Other methods, like glucose oxidase (GO), glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) and glucose dehydrogenase nicotinamide adenine dinucleotide (GDH-NAD) appears to be no or less affected by maltose interference and should be preferred [9-10].

To determine what type of method is used for monitoring glucose levels, review the labeling for BOTH the glucose monitor and the test strips used.  If in doubt, contact the manufacturer of the glucose monitors and test strips to determine the method that is used.

For important information about Polithera (icodextrin) and glucose monitors and test strips, please see the links below.  Details about glucose monitor manufacturers and product compatibility with Polithera (icodextrin) are included in the Country-Specific Glucose Monitor List (under "Additional Links").

Any adverse events should be reported to the MHRA. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/

Any adverse events relating to Vivisol srl products can also be reported to xxxxxxxxxxxxxx

Any suspected defective medicine should be reported to the MHRA. Reporting forms and information can be found at: www.mhra.gov.uk/safetyinformation/reportingsafetyproblems/index.htm

Any drug product quality complaints (including suspected defective medicines) relating to Vivisol srl products can be reported directly to xxxxxxxxxxxxxx

BIBLIOGRAPHY

  1. Moberly JB, Mujais S, Gehr T, Hamburger R, Sprague S, Kucharski A, Reynolds R, Ogrinc F, Martis L, Wolfson M. Pharmacokinetics of icodextrin in peritoneal dialysis patients. Kidney Int Suppl 2002; 81:S23-33. https://www.kidney-international.org/article/S0085-2538(15)48816-7/fulltext.
  2. Schleis TG. Interference of maltose, icodextrin, galactose, or xylose with some blood glucose monitoring systems. Pharmacotherapy 2007; 27:1313-21. https://doi.org/10.1592/phco.27.9.1313.
  3. Floré KM, Delanghe JR. Analytical interferences in point-of-care testing glucometers by icodextrin and its metabolites: an overview. Perit Dial Int 2009; 29:377-83. https://doi.org/10.3747/pdi.2008.00285.
  4. Galante O, Abriel A, Avnun LS, Rugachov B, Almog Y. Severe unrecognised hypoglycaemia presenting as pseudonormoglycaemia and unexplained coma in two patients with renal failure. BMJ Case Rep 2009; doi: 10.1136/bcr.07.2008.0416.
  5. Frias JP, Lim CG, Ellison JM, Montandon CM. Review of adverse events associated with false glucose readings measured by GDH-PQQ-based glucose test strips in the presence of interfering sugars. Diabetes Care 2010; 33:728-9. doi: 10.2337/dc09-1822.
  6. Tsai CY, Lee SC, Hung CC, Lee JJ, Kuo MC, Hwang SJ, Chen HC. False elevation of blood glucose levels measured by GDH-PQQ-based glucometers occurs during all daily dwells in peritoneal dialysis patients using icodextrin. Perit Dial Int 2010; 30:329-35. https://doi.org/10.3747/pdi.2008.00285.
  7. Dogan K, Kayalp D, Ceylan G, Azak A, Senes M, Duranay M, Yucel D. Falsely Elevated Glucose Concentrations in Peritoneal Dialysis Patients Using Icodextrin. J Clin Lab Anal 2016; 30:506-9. doi: 10.1002/jcla.21887.
  8. Chakraborty PP, Patra S, Bhattacharjee R, Chowdhury S. Erroneously elevated glucose values due to maltose interference in mutant glucose dehydrogenase pyrroloquinolinequinone (mutant GDH-PQQ) based glucometer. BMJ Case Rep 2017; doi: 10.1136/bcr-2017-219928.
  9. Perera NJ, Stewart PM, Williams PF, Chua EL, Yue DK, Twigg SM. The danger of using inappropriate point-of-care glucose meters in patients on icodextrin dialysis. Diabet Med 2011; 2810:1272-6.  https://doi.org/10.1111/j.1464-5491.2011.03362.x.
  10. Lan K, McAferty K, Shah P, Lieberman E, Patel DR, Cook CB, La Belle JT. A disposable tear glucose biosensor--part 3: assessment of enzymatic specificity. J Diabetes Sci Technol. 2011; 5:1108-15; doi: 10.1177/193229681100500511.

Product labelingImportant Safety InformationAdditional Links
Polithera Summary of Product CharacteristicsWarning Information for Healthcare Professionals

 


                                                      

                                       

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