Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
AZACITIDINE (UNII: M801H13NRU) (AZACITIDINE - UNII:M801H13NRU)
Seton Pharmaceuticals
AZACITIDINE
AZACITIDINE 100 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
AZACITIDINE- AZACITIDINE FOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SETON PHARMACEUTICALS ---------- 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 Baca dokumen lengkapnya