Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DECITABINE
INTEGRATED HEALTHCARE INDONESIA - Indonesia
DECITABINE
50 Mg
SERBUK INJEKSI LIOFILISASI
DUS, 1 VIAL @ 50 MG
BSP PHARMACEUTICALS S.P.A. - Italy
2022-02-14
1 DACOGEN ® DECITABINE for Injection PRODUCT NAME DACOGEN (decitabine) for Injection DOSAGE FORMS AND STRENGTHS DACOGEN (decitabine) for Injection is a white to almost white sterile lyophilized powder. Each 20 mL single dose vial contains 50 mg of decitabine. After aseptic reconstitution with 10 mL of Sterile Water for Injection, each mL of the concentrate of solution for infusion contains 5 mg of decitabine. For excipients, see _List of Excipients_. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Anti-neoplastic and Immunomodulating Agent, Pyrimidine Analogues. ATC Code: L01BC08 Mechanism of action Decitabine (5-Aza- 2’ -deoxycytidine) is a cytosine nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumor suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death. CLINICAL STUDIES _Clinical studies in MDS _ Phase 2 Study (DACO-020): 5-Day Dosing Regimen An open-label, single arm, multicenter study (DACO-20) was conducted to evaluate the efficacy of DACOGEN in MDS patients with any of the FAB subtypes. In this study, 99 patients with IPSS Intermediate-1, Intermediate-2, or high risk prognostic scores received DACOGEN by the 5-Day dosing regimen of 20 mg/m 2 intravenous infusion over 1-hour daily, on Days 1 to 5 every 4 weeks (1 cycle). The results were consistent with the results of the Phase 3 study and summarized in Table 1. Table 1: EFFICACY OF DACOGEN IN PHASE 2 STUDY DACO-020 Parameter DACOGEN (N=99) Overall Response Rate (CR+mCR+PR) 33(33%) Complete Remission (CR) 17(17%) Marrow Complete Remission (mCR) 16(16%) Overall Improvement Rate (CR+mCR+PR+HI) 51(52%) CR=complete remission; mCR=marrow complete remission; PR=partial remission; HI= hematological improvement; Source: DACO-020 CSR Phase 3 Study (D-0007): 3-Day Dosing Regimen A randomized, open-label multicenter, controlled study (D-0007) evaluated DACOGEN in Pročitajte cijeli dokument