DACOGEN

Land: Indonesië

Taal: Indonesisch

Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Werkstoffen:

DECITABINE

Beschikbaar vanaf:

INTEGRATED HEALTHCARE INDONESIA - Indonesia

INN (Algemene Internationale Benaming):

DECITABINE

Dosering:

50 Mg

farmaceutische vorm:

SERBUK INJEKSI LIOFILISASI

Eenheden in pakket:

DUS, 1 VIAL @ 50 MG

Geproduceerd door:

BSP PHARMACEUTICALS S.P.A. - Italy

Autorisatie datum:

2022-02-14

Productkenmerken

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