AZACITIDINE for injection powder lyophilized solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Seton Pharmaceuticals

INN（国际名称）:

AZACITIDINE

组成:

AZACITIDINE 100 mg

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

AZACITIDINE- AZACITIDINE FOR INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
SETON PHARMACEUTICALS
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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
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7) 8/2016
Warnings and Precautions (5.2, 5.3, 5.4, 5.5) 8/2016
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 (SC) injection or intravenous
(IV) infusion. Premedicate for nausea and vomiting. (2.1)
Repeat cycles every 4 weeks (2.2). 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 (2.2).
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
Lyophilized powder in 100 mg single-dose vials (3).
CONTRAINDICATIONS
Advanced Malignant Hepatic Tumors (4.1).
Hypersensitivity to A