Comparison of branded and generic imatinib plasma concentrations in patients with chronic myelogenous leukemia: unicentric study

Znanstveni rad - Izvorni znanstveni rad

• Autor: Alen Ostojić
• Autor: Dubravka Sertić
• Autor: Pavle Rončević
• Autor: Zinaida Perić
• Autor: Paula Granić
• Autor: Nikolina Matić
• Autor: Sandra Bašić-Kinda
• Autor: Ranka Serventi-Seiwerth
• Autor: Ivo Radman
• Autor: Renata Zadro
• Autor: Damir Nemet
• Autorova ustanova: Sveučilište u Zagrebu; Medicinski fakultet
• Znanstveno / umjetničko područje, polje i grana: BIOMEDICINA I ZDRAVSTVO; Kliničke medicinske znanosti

Sažetak (engleski)

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.

• Ključne riječi (engleski): Adult; Aged; Antineoplastic Agents/pharmacokinetics; Drug Costs; Drug Monitoring; Drugs, Generic; Female; Humans; Imatinib Mesylate/pharmacokinetics; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy; Male; Medication Adherence; Middle Aged; Protein Kinase Inhibitors/pharmacokinetics; Therapeutic Equivalency; Young Adult
• Jezik: engleski
• Vrsta publikacije: Znanstveni rad - Izvorni znanstveni rad
• Status objave: Objavljen
• Vrsta recenzije: Recenziran
• Verzija publikacije: Završna verzija rukopisa prihvaćena za objavljivanje (postprint)
• Naslov časopisa: Clinical Lymphoma Myeloma and Leukemia
• Brojčani podaci: vol. 16, br. 8, str. 472-476
• p-ISSN: 2152-2650
• DOI: https://doi.org/10.1016/j.clml.2016.04.003
• URN:NBN: urn:nbn:hr:105:528120
• Datum objave publikacije: 2016-08
• URL dokumenta: https://doi.org/10.1016/j.clml.2016.04.003
• Vrsta resursa: Tekst
• Prava pristupa: Otvoreni pristup
• Datum i vrijeme pohrane: 2024-03-28 09:00:14