DECITABINE- decitabine injection, powder, lyophilized, for solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)

Предлага се от:

Sandoz Inc

INN (Международно Name):

DECITABINE

Композиция:

DECITABINE 50 mg in 50 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Decitabine for injection is indicated for treatment of 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. None Pregnancy Category D [see WARNINGS AND PRECAUTIONS (5.2) ]  Decitabine for injection can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Decitabine for Injection in pregnant women. The developmental toxicity of decitabine was examined in mice exposed to single IP (intraperitoneal) injections (0, 0.9 and 3 mg/m2 , approximately 2% and 7% of the recommended daily clinical dose, respectively) over gestation days 8, 9, 10 or 11. No maternal toxicity w

Каталог на резюме:

Decitabine for Injection is supplied as follows: Storage Store vials at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DECITABINE- DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DECITABINE FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DECITABINE FOR
INJECTION.
DECITABINE FOR INJECTION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 03/2010
INDICATIONS AND USAGE
Decitabine for Injection is a nucleoside metabolic inhibitor indicated
for treatment of 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. (1)
DOSAGE AND ADMINISTRATION
There are two regimens for decitabine for injection administration.
With either regimen it is recommended that patients be
treated for a minimum of 4 cycles; however, a complete or partial
response may take longer than 4 cycles (2)
• TREATMENT REGIMEN – OPTION 1
Administer decitabine for injection at a dose of 15 mg/m by continuous
intravenous infusion over 3 hours repeated every
8 hours for 3 days. Repeat cycle every 6 weeks (2.1).
• TREATMENT REGIMEN – OPTION 2
Administer decitabine for injection at a dose of 20 mg/m by continuous
intravenous infusion over 1 hour repeated daily
for 5 days. Repeat cycle every 4 weeks (2.2).
DOSAGE FORMS AND STRENGTHS
Lyophilized powder in a single-dose vial, 50 mg/vial. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (> 50%) are neutropenia,
thrombocytopenia, anemia, and pyrexia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
S