AZACITIDINE injection, powder, lyophilized, for solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

AZACITIDINE (UNII: M801H13NRU) (AZACITIDINE - UNII:M801H13NRU)

Доступна з:

BluePoint Laboratories

ІПН (Міжнародна Ім'я):

AZACITIDINE

Склад:

AZACITIDINE 100 mg

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Azacitidine for Injection is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMML). Azacitidine for Injection is contraindicated in patients with - advanced malignant hepatic tumors [see Warnings and Precautions ( 5.2)] . - a known hypersensitivity to azacitidine [see Adverse Reactions ( 6.3)] . Risk Summary Based on its mechanism of action and findings in animals, Azacitidine for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no data on the use of azacitidine in pregnant women. Azacitidin

Огляд продуктів:

Azacitidine for Injection is supplied as 100mg of lyophilized powder in single-dose vials packaged in cartons of 1 vial (NDC 68001-313-56). Storage Store unreconstituted vials at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Discard unused portion. Handling and Disposal Azacitidine for Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Sterile, Nonpyrogenic, Preservative-free. This vial stopper is not made with natural rubber latex.

Статус Авторизація:

New Drug Application

Характеристики продукта

AZACITIDINE- AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
BLUEPOINT LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZACITIDINE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZACITIDINE FOR
INJECTION.
AZACITIDINE FOR INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Azacitidine for Injection is a nucleoside metabolic inhibitor
indicated for the treatment of patients with the
following FAB myelodysplastic syndrome (MDS) subtypes: Refractory
anemia (RA) or refractory anemia
with ringed sideroblasts (RARS) (if accompanied by neutropenia or
thrombocytopenia or requiring
transfusions), refractory anemia with excess blasts (RAEB), refractory
anemia with excess blasts in
transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) (
1).
DOSAGE AND ADMINISTRATION
The recommended starting dose for the first treatment cycle, for all
patients regardless of baseline
hematology values, is Azacitidine for Injection 75 mg/m
daily for 7 days to be administered by
subcutaneous injection or intravenous infusion. Premedicate for nausea
and vomiting ( 2.1).
Repeat cycles every 4 weeks. After 2 cycles, may increase dose to 100
mg/m
if no beneficial effect is
seen and no toxicity other than nausea and vomiting has occurred.
Patients should be treated for a
minimum of 4 to 6 cycles. Complete or partial response may require
additional treatment cycles ( 2.2).
Continue treatment as long as the patient continues to benefit ( 2.2).
Monitor patients for hematologic response and for renal toxicity;
delay or reduce dosage as appropriate
( 2.3, 2.4, 2.5).
DOSAGE FORMS AND STRENGTHS
For Injection: 100 mg as a lyophilized powder in single-dose vial for
reconstitution ( 3).
CONTRAINDICATIONS
Advanced malignant hepatic tumors ( 4).
Hypersensitivity to azacitidine ( 4).
WARNINGS AND PRECAUTIONS
Myelosuppression: Monitor complete blood counts frequently (CBC) (
5.1).
Hepatic T