H., S., H.M., S., A., R., S. Kotb, N. (2020). Toxic interactions of Romiplostim and Rituximab in normal and thrombocytopenic Rats. Journal of Applied Veterinary Sciences, 5(1), 1-10. doi: 10.21608/javs.2019.20470.1000
Saeed H.; Sayed H.M.; Ramadan A.; Nahla S. Kotb. "Toxic interactions of Romiplostim and Rituximab in normal and thrombocytopenic Rats". Journal of Applied Veterinary Sciences, 5, 1, 2020, 1-10. doi: 10.21608/javs.2019.20470.1000
H., S., H.M., S., A., R., S. Kotb, N. (2020). 'Toxic interactions of Romiplostim and Rituximab in normal and thrombocytopenic Rats', Journal of Applied Veterinary Sciences, 5(1), pp. 1-10. doi: 10.21608/javs.2019.20470.1000
H., S., H.M., S., A., R., S. Kotb, N. Toxic interactions of Romiplostim and Rituximab in normal and thrombocytopenic Rats. Journal of Applied Veterinary Sciences, 2020; 5(1): 1-10. doi: 10.21608/javs.2019.20470.1000
Toxic interactions of Romiplostim and Rituximab in normal and thrombocytopenic Rats
1Central Administration for Pharmaceutical Affairs, Cairo, Egypt
2Department of Pharmacology and Toxicology, Faculty of Pharmacy, Cairo University, Egypt.
3Department of Pharmacology, Faculty of Veterinary Medicine, Cairo University, Cairo, Egypt.
4Department of Biochemistry, National Organization for Research and Control of Biologicals, Egypt.
Receive Date: 03 December 2019,
Revise Date: 20 December 2019,
Accept Date: 21 December 2019
Abstract
Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by immunologic destruction of normal platelets and insufficient production of platelets, as mediated by autoantibodies. Because of the progression of the disease and its multiple causes a combination of treatments used for management of ITP would be a point of interest. Co-administration of therapies may be useful in patients who are refractory to monotherapies and may result in a booster response because they target multiple mechanisms. Romiplostim is a potent drug used for the management of acute ITP and used in combination with other treatment options for ITP. The combination of Rituximab and Romiplostim may inhibit platelet destruction and at the same time increase platelet production. This combination can lead to a strong and a massive increase in platelet counts. In Preclinical studies of Romiplostim safety margins could not be reliably estimated. Although some clinical studies provided some information about the safety profile of this drug. The goal of this study is to investigate the safety of co-treatment of Romiplostim with Rituximab as compared to each of these drugs in normal and thrombocytopenic rats. The measured safety parameter was evaluated for the liver and kidney function in normal and diseased rats. The safety of this regimen should be taken in consideration, so that a balance between the harmful effects and beneficial response could be attained. Future studies are necessary to investigate the safety and efficacy balance of Romiplostim and Rituximab alone or in combination with each other for management of thrombocytopenia.
ABOULAFIA, D. and VISHNU, P. 2016. Long-term safety and efficacy of Romiplostim for treatment of immune thrombocytopenia. Journal of Blood Medicine 99.
ABOULAFIA, D. AND VISHNU,P. 2016. Long-term safety and efficacy of Romiplostim for treatment of immune thrombocytopenia. Journal of Blood Medicine 99.
ARNOLD, D.M., DENTALI, F., CROWTHER, M.A., MEYER, R.M., COOK, R.J., SIGOUIN, C., FRASER, G.A., LIM, W. and KELTON, J.G. 2007. Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura (Structured abstract). Annals of Internal Medicine 146: 25–33.
BERGMEYER, H.U. and HORDER, M. 1980. IFCC methods for the measurement of catalytic concentration of enzymes. 3. IFCC method for alanine aminotransferase. Journal of Clinical Chemistry and Clinical Biochemistry 18: 521–534.
BORKER, A. and CHOUDARY, N. 2011. Rituximab. Indian Pediatrics 48.
BUSSEL, J. B., HSIEH, L., BUCHANAN, G. R., STINE, K., KALPATTHI, R., GNARRA, D. J., HO, R. H., NIE, K., and EISEN, M. 2015. Long-Term Use of the Thrombopoietin-Mimetic Romiplostim in Children With Severe Chronic Immune Thrombocytopenia (ITP). Pediatric Blood Cancer 62: 208–213.
CHAPIN, J., LEE, C.S., ZHANG, H., ZEHNDER, J.L. and BUSSEL, J.B. 2016. Gender and duration of disease differentiate responses to rituximab–dexamethasone therapy in adults with immune thrombocytopenia. American Journal of Hematology 91: 907–911.
CHUGH, S., DARVISH-KAZEM, S., LIM, W., CROWTHER, M.A., GHANIMA, W., WANG, G., HEDDLE, N.M., KELTON, J.G. and ARNOLD, D.M. 2015. Rituximab plus standard of care for treatment of primary immune thrombocytopenia: A systematic review and meta-analysis. The Lancet Haematology 2: e75–e81.
CONTIS, A., LAZARO, E., GREIB, C., PELLEGRIN, J.-L. and VIALLARD, J.-F. 2013. Romiplostim as early treatment for refractory primary immune thrombocytopenia. International Journal of Hematology 98: 520–524.
COOK, J.G.H. 1971. Creatinine assay in the presence of protein. Clinica Chemica Acta 32: 485–486.
CUKER, A. 2010. Toxicities of the Thrombopoietic Growth Factors. Seminars in Hematology 47: 289.
FOSSATI, P., PRENCIPE, L. and BERTI, G. 1980. Use of 3,5-dichloro-2-hydroxybenzenesulfonic acid/4-aminophenazone chromogenic system in direct enzymic assay of uric acid in serum and urine. Clinical Chemistry 26: 227–231.
GARBER, J.C. 2010. Guide for The Care and Use of Laboratory Animals: Eighth Edition.
GAW, A., MURPHY, M., SRIVASTAVA, R., COWAN, R.A. and O’REILLY, D.S.J. 2013. Clinical Biochemistry E-Book: An Illustrated Colour Text Elsevier Health Sciences, Fifth edition.
HRUBAN, R.H., STERNBERG, S.S., MEYERS, P., FLEISHER, M., MENENDEZ-BOTET, C. and BOITNOTT, J.K. 1991. Fatal Thrombocytopenia and Liver Failure Associated with Carboplatin Therapy. Cancer Investigation 9: 263–268.
JANSSENS, A. 2012. Romiplostim for the treatment of primary immune thrombocytopenia. Expert Review of Hematology 5: 133–144.
KASHIWAGI, H. and TOMIYAMA, Y. 2013. Pathophysiology and management of primary immune thrombocytopenia. International Journal of Hematology 98: 24–33.
KING, P.D. and PERRY, M.C. 2001. Hepatotoxicity of Chemotherapy. The oncologist 6: 162–176.
KUTER, D.J., BUSSEL, J.B., LYONS, R.M., PULLARKAT, V., GERNSHEIMER, T.B., SENECAL, F.M., ALEDORT, L.M., GEORGE, J.N., KESSLER, C.M., SANZ, M. A, LIEBMAN, H. A, SLOVICK, F.T., DE WOLF, J.T.M., BOURGEOIS, E., GUTHRIE, T.H., NEWLAND, A., WASSER, J.S., HAMBURG, S.I., GRANDE, C., LEFRÈRE, F., ELI LICHTIN,A., TARANTINO,M. D., TEREBELO, H. R., VIALLARD, J.-F., CUEVAS,F. J., GO, R. S., HENRY, D. H., REDNER, R. L., RICE, L., SCHIPPERUS, M. R., GUO, D. M. and NICHOL, J. L. 2008. Efficacy of Romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet 371: 395–403.
KUTER, D.J., MUFTI, G.J., BAIN, B.J., HASSERJIAN, R.P. and DAVIS W, R.M. 2009. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with Romiplostim. Blood 114: 3748–3756.
LIANG, Y., ZHANG, L., GAO, J., HU, D. and AI, Y. 2012. Rituximab for children with immune thrombocytopenia: A systematic review. PLoS ONE 7: Issue 5, e36698.
MARANGON, M.; VIANELLI, N.; PALANDRI, F.; MAZZUCCONI, M.G.; SANTORO, C.; BARCELLINI, W.; FATTIZZO, B.; VOLPETTI, S.; LUCCHINI, E.; POLVERELLI, N., CARPENEDO, M., ISOLA, M., FANIN, R. and ZAJA, F. 2016. Rituximab in immune thrombocytopenia: gender, age, and response as predictors of long-term response. Eur J Haematol 98: 371–377.
MOUSSA, M.M. and MOWAFY, N. 2013. Preoperative use of Romiplostim in thrombocytopenic patients with chronic hepatitis C and liver cirrhosis. Journal of Gastroenterology and Hepatology 28: 335–341.
NEUNERT, C., LIM, W. and CROWTHER, M. 2011. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. , Blood 117: 4190–4207.
PAGET, G.E. and BARNES, J.M. 1964. Toxicity tests. Evaluation of drug activities: pharmacometrics 1: 135–165.
POHLEN, M., SARGIN, B., ZICHOLL, S., BISPING, G., MÜLLER-TIDOW, C., BERDEL, W.E., MESTERS, R. and KOSCHMIEDER, S. 2010. Combination of Romiplostim and rituximab: Effective therapy of severe immune thrombocytopenia. European Journal of Haematology 84: 362–364.
TAKABATAKE, T., OHTA, H., ISHIDA, Y.I., HARA, H., USHIOGI, Y. and HATTORI, N. 1988. Low Serum Creatinine Levels in Severe Hepatic Disease. Archives of Internal Medicine 148: 1313–1315.
TALKE, H. and SCHUBERT, G.E. 1965. Enzymatische Harnstoffbestimmung in Blut und Serum im optischen Test nachWarburg. Journal of Molecular Medicine 43: 174–175.
TIETZ, N.W., RINKER, A.D. and SHAW, L.M. 1983. IFCC methods for the measurement of catalytic concentration of enzymes Part 5. IFCC method for alkaline phosphatase (orthophosphoric-monoester phosphohydrolase, alkaline optimum, EC 3.1. 3.1). Journal of clinical chemistry and clinical biochemistry 21: 731.
ULICH, T.R., DEL CASTILLO, J., YIN, S., SWIFT, S., PADILLA, D., SENALDI, G., BENNETT, L., SHUTTER, J., BOGENBERGER, J., SUN, D., SAMAL, B., SHIMAMOTO, G., LEE, R., STEINBRINK, R., BOONE, T., SHERIDAN, W.T. and HUNT, P. 1995. Megakaryocyte growth and development factor ameliorates carboplatin- induced thrombocytopenia in mice. Blood 86: 971–976.
VADHAN-RAJ, S. 2009. Management of Chemotherapy-Induced Thrombocytopenia: Current Status of Thrombopoietic Agents. Seminars in Hematology 46: S26–S32.
VARLEY, H. 1954. Practical clinical biochemistry, 4th edition.
WANG, Y.M.C., SLOEY, B., WONG, T., KHANDELWAL, P., MELARA, R. and SUN, Y.N. 2011. Investigation of the pharmacokinetics of Romiplostim in rodents with a focus on the clearance mechanism. Pharmaceutical Research 28: 1931.
ZHOU, H., XU, M., QIN, P., ZHANG, H.Y., YUAN, C.L., ZHAO, H.G., CUI, Z.G., MENG, Y.S., WANG, L., ZHOU, F., WANG, X., LI, D.Q., BI, K.H., ZHU, C.S., GUO, C.S., CHU, X.X., WU, Q.C., LIU, X.G., DONG, X.Y., LI, J., PENG, J. and HOU, M. 2015. A multicenter randomized open-label study of rituximab plus rhTPO vs rituximab in corticosteroid-resistant or relapsed ITP. Blood 125: 1541–1547.
ZUFFEREY, A., KAPUR, R. and SEMPLE, J. 2017. Pathogenesis and Therapeutic Mechanisms in Immune Thrombocytopenia (ITP). Journal of Clinical Medicine 6: 16.
View on SCiNiTO
Top