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AAVPT Sponsored Workshop Issues and Alternatives for Safety Assessment of Macrocyclic Lactones in P-glycoprotein Deficient Dogs

SELECTED REFERENCES

1. Barbet J, Snook T, Gay JM, Mealey KL ABCB1 (MDR1) genotype is associated with adverse reactions in dogs treated with for generalized demodicosis; Vet Dermatol 2009;20:111- 114. 2. Coelho JC, Tucker R, Mattoon J, Roberts G, Waiting DK, Mealey KL. Biliary excretion of technetium- 99m-sestamibi in wild-type dogs and in dogs with intrinsic (ABCB1-1Δ mutation) and extrinsic (ketoconazole treated) P-glycoprotein deficiency. J Vet Pharmacol Therap 2009 32:417-421. 3. Deshpande D, Hill KE, Mealey KL, Chambers JP, Gieseg MA. The effect of the canine ABCB1-1D mutation on sedation after intravenous administration of acepromazine. J Vet Int Med 2016 30(2):636-41. 4. Elmshauser S, Straehle L. C., Kranz J, Krebber R, and Geyer J. Brain penetration of emodepside is increased in P-glycoprotein-deficient mice and leads to neurotoxicosis. J. vet. Pharmacol. Therap. 2014; 38:74-79. 5. Fassler, P. E., Tranquilli, W. J., Paul, A. J., Soll, M. D., DiPietro, J. A., & Todd, K. S. (1991). Evaluation of the safety of administered in a beef-based formulation to ivermectin-sensitive Collies. Journal of the American Veterinary Medical Association, 199(4), 457-460. 6. Geary T. G. and Moreno Y. Macrocyclic Lactone Anthelmintics: Spectrum of Activity and Mechanism of Action. Current Pharmaceutical Biotechnology, 2012; 13:866-872. 7. Geyer J and Janko C. Treatment of MDR1 Mutant Dogs with Macrocyclic Lactones. Current Pharmaceutical Biotechnology. 2012; 13:969-986. 8. Janko C and Geyer J. has a lower neurotoxic potential but comparable brain penetration in P-glycoprotein-deficient CF-1 mice compared to ivermectin. J Vet Pharmacol Therap 2012; 36:275-284. 9. Kiki-Mvouaka S, Menez C, Borin C, Lyazrhi F, Foucaud-Vignault M, Dupuy J, Collet X, Alvinerie M, and Lespine A. Role of P-Glycoprotein in the Disposition of Macrocyclic Lactones: A Comparison between Ivermectin, Eprinomectin, and Moxidectin in Mice. DMD 2010; 38:573-580. 10. Lacher S. E., Skagen K, Veit J, Dalton R, and Woodahl E. L. P-Glycoprotein Transport of Neurotoxic Pesticides. J Pharmacol Exp Ther, 2015; 355:99-107. 11. Lespine A, Menez C, Bourguinat C, and Prichard R. K. P-glycoproteins and other multidrug resistance transporters in the pharmacology of anthelmintics: Prospects for reversing transport- dependent anthelmintic resistance. Drugs and Drug Resistance, 2012; 2:58-75. 12. Mealey KL. Adverse drug reactions associated with drug transporters. Vet Clin North Am Small Anim Pract 2013 43(5):1067-1078. 13. Mealey KL, Bentjen SA, Gay J, Cantor GH. Ivermectin sensitivity in Collies is associated with a deletion mutation of the mdr1 gene. Pharmacogenetics, 2001;11:727-733. 14. Mealey KL, Dassanayake S, Burke NS. Establishment of a cell line for assessing drugs as canine P- glycoprotein substrates: Proof of principle. J Vet Pharmacol Ther 2017; 40(5):545-551. 15. Mealey KL, Fidel J, Gay JM, Impellizeri J, Clifford C, Bergman PJ. ABCB1-1D Polymorphism can predict hematologic toxicity in dogs treated with vincristine; J Vet Int Med 2008;996-1000. 16. Mealey KL, Fidel J. P-glycoprotein-mediated drug interactions in oncology patients. J Vet Int Med 2015 29(1):1-6. 17. Mealey KL, Greene S, Bagley R, Gay J, Tucker R, Gavin P, Waiting D, Schmidt K, Nelson F. P- glycoprotein contributes to the blood-brain, but not blood-CSF, barrier in a spontaneous canine P- glycoprotein knockout model Drug Metabolism and Disposition, 2008;36(6):1073-1079. 18. Mealey KL. How should I treat dogs and cats with MDR1 mutations? Therapeutics Briefs 2016,3:12- 23. 19. Mealey KL. MDR1 gene mutations & drug therapy. Clinicians Brief May 2016 (online cliniciansbrief.com) 20. Mealey KL. Therapeutic implications of the MDR1 gene. Journal of Veterinary Pharmacology and Therapeutics, 2004;27:257-264. 21. Mealey KL, Waiting D, Raunig DL, Schmidt KR, Nelson FR. Oral of P-glycoprotein substrate drugs do not differ between ABCB1-1D and ABCB1 wild type dogs. J Vet Pharmacol Therap 2010 33(5):453-460. 22. Menez C., Sutra J-F., Prichard R., and Lespine A. Relative Neurotoxicity of Ivermectin and Moxidectin in Mdr1ab (-/-) Mice and Effects on Mammalian GABA(A) Channel Activity. PLOS Neglected Tropical Diseases. 2012; 6:11. 23. Marques-Santos L. F., Bernardo R. R., de Paula E. F., and Rumjanek V. M. Cyclosporin A and Trifluoperazine, Two Resistance-Modulating Agents, Increase Ivermectin Neurotoxicity in Mice. Pharmacology & Toxicology, 1999; 84:125-129. 24. Myers M. J., Martinez M., Li H., Qiu J., Troutman L., Sharkey M., and Yancy H. F. Influence of ABCB1 Genotype in Collies on the and of Loperamide in a Dose- Escalation Study. Drug Metab Dispos. 2015; 43:1392-1407. 25. Neff MW, Robertson KR, Wong A, Safra N, Broman KW, Slatkin M, Mealey KL, Pedersen NC. Breed distribution and history of canine mdr1-1d, a pharmacogenetic mutation that marks the emergence of breeds of the collie lineage. Proceedings of the National Academy of Sciences, 2004; 101:11725-11730. 26. Orzechowski K. L., Swain M. D., Robl M. G., Tinaza C. A., Swaim H. L., Jones Y. L., Myers M. J., and Yancy H. F. Neurotoxic effects of ivermectin administration in genetically engineering mice with targeted insertion of the mutated canine ABCB1 gene. AJVR. 2012; 73:9. 27. Paul, A., D. Hutchens, L. Firkins and M. Borgstrom (2004). "Dermal safety study with imidacloprid/moxidectin topical solution in the ivermectin-sensitive collie." Veterinary parasitology 121(3): 285-291. 28. Paul, A. J., Hutchens, D. E., Firkins, L. D., & Keehan, C. M. (2004). Effects of dermal application of 10.0% imidacloprid-0.08% ivermectin in ivermectin-sensitive Collies. American journal of veterinary research, 65(3), 277-278. 29. Paul A. J., Tranquilli W. J., Seward R. L., Todd K. S., and DiPietro J. A. Clinical observations in Collies given ivermectin orally. Am J. Vet Res. 1987; 48:684-685. 30. Paul, A. J., Tranquilli, W. J., Todd Jr, K. S., Wallace, D. H., & Soll, M. (1991). Evaluating the safety of administering high doses of a chewable ivermectin tablet to collies. Veterinary medicine (USA). 31. Paul, A. J., W. J. Tranquilli and D. E. Hutchens (2000). "Safety of moxidectin in avermectin-sensitive collies." American Journal of Veterinary Research 61(5): 482-483. 32. Roulet A., Puel O., Gesta S., Lepage J-F., Drag M., Soll M., Alvinerie m., and Pineau T. MDR 1- deficient genotype in Collie dogs hypersensitive to the P-glycoprotein substrate ivermectin. European Journal of Pharmacology. 2003; 460:85-91. 33. Sherman J, Paul A, Firkins L. Evaluation of the safety of spinosad and milbemycin 5-oxime orally administered to Collies with the MDR1 gene mutation. American Journal Of Veterinary Research [serial online]. January 2010;71(1):115-119. Available from: STM Source, Ipswich, MA. 34. Swain M. D., Orzechowski K. L., Swaim H. L., Jones Y. L., Robl M. G., Tinaza C. A., Myers M. J., Jhingory M. V., Buckely L. E., Lancaster V. A., and Yancy H. F. P-gp substrate-induced neurotoxicity in an Abcb 1a knock-in/Abcb1b knock-out mouse model with a mutated canine ABCB1 targeted insertion. Research in Veterinary Science. 2013; 94:656-661. 35. Tranquilli W. J., Paul A. J., and Seward R. L. Ivermectin plasma concentrations in Collies sensitive to ivermectin-induced toxicosis. Am J. Vet Res. 1989; 50:5. 36. Tranquilli W. J., Paul A. J., Seward R. L., Todd K. S., and Dipietro J. A. Response to physostigmine administration in collie dogs exhibiting ivermectin toxicosis. J. vet. Pharmacol. Therap. 1987; 10:96- 100. 37. Tranquilli W, Paul A, Todd K. Assessment of toxicosis induced by high-dose administration of milbemycin oxime in Collies. American Journal of Veterinary Research [serial online]. 1991;52(7):1170-1172. Available from: CAB Abstracts, Ipswich, MA. Accessed August 27, 2018. 38. Wright HM, Chen AV, Talcott PA, Poppenga RH, Mealey KL Intravenous fat emulsion as treatment for ivermectin toxicosis in three dogs homozygous for the ABCB1-1D gene mutation. J Vet Emerg Crit Care 2011;21:666-672. 39. Zhu M., Ming Y., Swaim H., Swain M. D., Myers M. J., Deaver C., Wu X., Jones Y. L., and Yancy H. F. Identification of potential biomarkers of P-glycoprotein substrate neurotoxicity in transgenic mice expressing the mutated canine ABCB1 gene. AJVR. 2014; 75:12. 40. Zhu M., Yancy H. F., Deaver C, Jones Y. J., and Myers M. J. Loperamide-induced expression of immune and inflammatory genes in Collies associated with ivermectin sensitivity. J. vet. Pharmacol. Therap. 2015; 39:131-137.