Vidaza® is the commercial brand name of Azacitidine for Injection, a hypomethylating agent. It incorporates into DNA and RNA, inhibits DNA methyltransferase, reduces DNA hypermethylation and restores expression of silenced tumor suppressor genes, thereby exerting anti-tumor effects.
Main Indications
Treatment of adult patients with International Prognostic Scoring System intermediate-1, intermediate-2 and high-risk myelodysplastic syndromes (MDS);
Treatment of chronic myelomonocytic leukemia and acute myeloid leukemia with 20%-30% blasts.
Clinical Research
A pivotal phase III trial demonstrated that azacitidine significantly prolongs overall survival compared with conventional care regimens in higher-risk MDS patients;
Studies showed that azacitidine can improve hematologic parameters, reduce transfusion dependence and delay progression to acute myeloid leukemia;
Clinical data from Chinese MDS patients confirmed consistent efficacy and manageable safety profile.
Common Side Effects
Severe but important risks: Severe myelosuppression including neutropenia, thrombocytopenia and anemia, tumor lysis syndrome, severe hypersensitivity reactions;
Common mild adverse reactions: Injection site reactions, nausea, vomiting, diarrhea, constipation, fever, fatigue, headache and decreased appetite.
Approval Status in China
Original drug Vidaza® (Azacitidine for Injection, specification:100mg per vial) was officially approved for marketing in China in 2017. It is currently a prescription hypomethylating anticancer drug.
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