DACOGEN (Decitabine) 50 mg Powder for Concentrate for Solution for Infusion

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

DECITABINE

Dostopno od:

JOHNSON & JOHNSON SDN. BHD.

INN (mednarodno ime):

DECITABINE

Enote v paketu:

1 Vials

Izdeluje:

BSP Pharmaceuticals S.p.A.

Lastnosti izdelka

PRODUCT NAME
DACOGEN
®
(decitabine) 50 mg Powder for Concentrate for Solution for Infusion
DOSAGE FORMS AND STRENGTHS
DACOGEN (decitabine) 50 mg Powder for Concentrate for Solution for
Infusion 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_
.
CLINICAL INFORMATION
INDICATIONS
DACOGEN is indicated for treatment of adult patients with
myelodysplastic syndromes (MDS)
including previously treated and untreated,
_de novo _
and secondary MDS of all French-
American-British subtypes (refractory anemia, refractory anemia with
ringed sideroblasts,
refractory anemia with excess blasts, refractory anemia with excess
blasts in transformation,
and chronic myelomonocytic leukemia) and intermediate-1,
intermediate-2, and high-risk
International Prognostic Scoring System groups.
DACOGEN is indicated for the treatment of adult patients aged 65 and
above with newly
diagnosed
_de novo_
or secondary acute myeloid leukemia (AML), according to the World
Health
Organization
(WHO)
classification,
who
are
not
candidates
for
standard
induction
chemotherapy.
DOSAGE AND ADMINISTRATION
DACOGEN administration must be initiated under the supervision of
physicians experienced
in the use of chemotherapeutic medicinal products.
TREATMENT REGIMEN IN MYELODYSPLASTIC SYNDROMES (MDS)
Pre-Medications and Baseline Testing
•
Consider pre-medicating for nausea with antiemetics.
•
Conduct baseline laboratory testing: complete blood count (CBC) with
platelets, serum
hepatic panel, and serum creatinine.
DACOGEN Regimen Options
_Three Day Regimen _
Administer DACOGEN at a dose of 15 mg/m
2
by continuous intravenous infusion over 3 hours
repeated every 8 hours for 3 days. Repeat cycles every 6 weeks upon
hematologic recovery
(ANC at least 1,000/μL and platelets at least 50,000//μL) for a
minimum of