prikaz prve stranice dokumenta Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study
  Download
PDF 970.89 KB
Scientific paper - Original scientific paper
Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study
Clinical Lymphoma Myeloma and Leukemia, 16 (2016), 8; 472-476. https://doi.org/10.1016/j.clml.2016.04.003
Ostojić, Alen; Sertić, Dubravka; Rončević, Pavle; Perić, Zinaida; Granić, Paula; Matić, Nikolina; Bašić-Kinda, Sandra; Serventi-Seiwerth, Ranka; Radman, Ivo; Zadro, Renata; Nemet, Damir

Institutional repository: Dr Med - University of Zagreb School of Medicine Digital Repository

Cite this document

Ostojić, A., Sertić, D., Rončević, P., Perić, Z., Granić, P., Matić, N. ... Nemet, D. (2016). Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study. Clinical Lymphoma Myeloma and Leukemia, 16. (8), 472-476. doi: 10.1016/j.clml.2016.04.003

Ostojić, Alen, et al. "Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study." Clinical Lymphoma Myeloma and Leukemia, vol. 16, no. 8, 2016, pp. 472-476. https://doi.org/10.1016/j.clml.2016.04.003

Ostojić, Alen, Dubravka Sertić, Pavle Rončević, Zinaida Perić, Paula Granić, Nikolina Matić, Sandra Bašić Kinda, et al. "Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study." Clinical Lymphoma Myeloma and Leukemia 16, no. 8 (2016): 472-476. https://doi.org/10.1016/j.clml.2016.04.003

Ostojić, A., et al. (2016) 'Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study', Clinical Lymphoma Myeloma and Leukemia, 16(8), pp. 472-476. doi: 10.1016/j.clml.2016.04.003

Ostojić A, Sertić D, Rončević P, Perić Z, Granić P, Matić N, and sur.. Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study. Clinical Lymphoma Myeloma and Leukemia [Internet]. 2016 August [cited 2024 May 06];16(8):472-476. doi: 10.1016/j.clml.2016.04.003

A. Ostojić, et al., "Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study", Clinical Lymphoma Myeloma and Leukemia, vol. 16, no. 8, pp. 472-476, August 2016. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:105:528120. [Accessed: 06 May 2024]

Metadata
Title (english)Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study
AuthorAlen Ostojić
AuthorDubravka Sertić
AuthorPavle Rončević
AuthorZinaida Perić
AuthorPaula Granić
AuthorNikolina Matić
AuthorSandra Bašić-Kinda
AuthorRanka Serventi-Seiwerth
AuthorIvo Radman
AuthorRenata Zadro
AuthorDamir Nemet
Author's institutionUniversity of Zagreb
School of Medicine
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Clinical Medical Sciences
Abstract (english)
INTRODUCTION: For over a decade, imatinib has been the first-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). Doubts on the bioequivalence and bioavailability of emerging generic compounds have been expressed. Adequate imatinib plasma concentration ([IPC] ≥1000 μmol/L) is associated with a better chance of optimal treatment response in patients with CML. In this study, we compared the achieved IPCs between the branded compound and its 2 generic forms. ----- PATIENTS AND METHODS: IPCs were compared in 24 consecutive patients with CML in the first chronic phase who changed from branded to generic imatinib. The median age was 49 years (range, 22-76 years). Fifteen of them were male. Six patients were switched to Neopax, 13 to Imakrebin, and 5 patients received both generics consecutively. All compounds were used in an equivalent dose of 400 mg orally once daily for at least 1 month before plasma concentrations were measured. High-performance liquid chromatography was used to determine imatinib plasma concentration from a specimen collected 21 to 24 hours after the last dose. ----- RESULTS: The median IPC achieved with branded imatinib was 1454 μmol/L (range, 485-2707 μmol/L) with 18 patients (75%) having IPC ≥ 1000 μmol/L. For Neopax and Imakrebin, median IPCs were 1717 μmol/L (range, 1249-3630 μmol/L) and 1458 μmol/L (range, 707-880 μmol/L), respectively, with 11 of 11 (100%) and 16 of 18 (89%) patients having IPC ≥ 1000 μmol/L. No significant difference in measured IPCs between all 3 compounds was found (P > .257). ----- CONCLUSION: When taken at equivalent doses, imatinib generics are bioequivalent and comparable in clinical efficacy and have the potential for substantial savings in the treatment cost for CML.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review
Publication versionAccepted version
Journal titleClinical Lymphoma Myeloma and Leukemia
Numberingvol. 16, no. 8, pp. 472-476
p-ISSN2152-2650
DOIhttps://doi.org/10.1016/j.clml.2016.04.003
URN:NBNurn:nbn:hr:105:528120
Publication2016-08
Document URLhttps://doi.org/10.1016/j.clml.2016.04.003
Type of resourceText
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2024-03-28 09:00:14