The focus of the prescribed information
These points do not include all the information needed to use VIDAZA safely and effectively. View the complete prescribing information for VIDAZA.
VIDAZA (for injection)Azacitidine), subcutaneous or intravenous use
Recent major changes
Indications and usage
VIDAZA is a nucleoside metabolism inhibitor for the treatment of the following FABMyelodysplastic syndrome (MDS)Subtypes of patients: refractory anemia (RA) or refractory anemia with annular fibroblasts (RARS) (if accompaniedNeutrophil reductionOr thrombocytopenia or need blood transfusion), refractory with anemia of excess cytosis (RAEB), refractory anemia with excess mother cells during transformation (RAEB-T) and chronic myelomonocytic leukemia (CMMOL) .
Dosage and administration
For all patients, regardless of baseline hematology values, the recommended starting dose for the first treatment cycle was VIDAZA 75 mg/m 2 per day for 7 days, administered by subcutaneous (SC) injection or intravenous (IV) infusion. Prevent nausea and vomiting.
The cycle is repeated every 4 weeks (2.2). If no beneficial effects are seen and no toxicity other than nausea and vomiting occurs, the dose can be increased to 100 mg / m 2 (2.2) after 2 cycles. Patients should be treated for at least 4 to 6 cycles. Full or partial response may require additional treatment cycles
As long as the patient continues to benefit, continue treatment
Monitoring the patient's hematologic response and nephrotoxicity; appropriate delay or reduction of dose
Dosage form and strength
Lyophilized powder in a 100 mg single dose vial
Contraindications
Advanced malignant liver tumor
Allergic to azacitidine or mannitol
Warnings and precautions
Anemia, neutropenia and thrombocytopenia: frequent monitoring of whole blood counts (CBC)
Hepatotoxicity: Patients with severe previous liver damage have a higher risk of toxicity
Nephrotoxicity: monitoring the toxicity of patients with impaired renal function, because azacitidine and its metabolites are mainly excreted by the kidneys.
Tumor lysis syndrome: VIDAZA may cause fatal or severe tumor lysis syndrome, including patients with MDS. Assess baseline risk and monitor and treat as appropriate
Embryo – Fetal risk: VIDAZA can cause fetal damage. It is recommended that women with reproductive potential have a potential risk to the fetus and avoid pregnancy
Adverse reactions
The most common adverse events (> 30%) in the SC route are: nausea, anemia, thrombocytopenia, vomiting, fever, leukopenia, diarrhea, erythema at the injection site, constipation, neutropenia, and ecchymosis. The most common adverse effects of the IV route include sputum, severe, weakness, and hypokalemia.
For a specific group of people
Lactation: Stop breastfeeding considering the importance of drugs to the mother
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