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Vidaza (Azacitidine Subcutaneous) - Summary

 
 



VIDAZA SUMMARY

Vidaza™ (azacitidine for injectable suspension) contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1 H)-one.

Vidaza is indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.


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NEWS HIGHLIGHTS

Published Studies Related to Vidaza (Azacitidine Subcutaneous)

Thrice weekly azacitidine does not improve hematological responses in lower-risk myelodysplastic syndromes: a study of the Hoosier Oncology Group. [2011.08]
Prolonged administration of methyl transferase inhibitors may increase response rates in myelodysplastic syndromes (MDS). Fourteen MDS patients with anemia and less than 10% marrow blasts received azacitidine 50 mg/m(2) thrice weekly for 2 weeks every 4 weeks; 7 also received weekly erythropoietin...

Effects of azacitidine compared with conventional care regimens in elderly (>/= 75 years) patients with higher-risk myelodysplastic syndromes. [2010.12]
This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (>/= 75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial... Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged >/= 75 years with good performance status and higher-risk MDS.

Phase 2 study of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving azacitidine therapy. [2010.10.28]
We evaluated the efficacy and safety of romiplostim, a thrombopoietin mimetic, in patients with low- or intermediate-risk myelodysplastic syndromes (MDS) receiving azacitidine therapy. Forty patients with low- or intermediate-risk MDS were stratified by baseline platelet counts (< 50 vs >/= 50 x 10(9)/L) and randomized to romiplostim 500 mug or 750 mug or placebo subcutaneously once weekly during 4 cycles of azacitidine...

Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine*. [2010.08]
OBJECTIVE: Myelodysplastic syndrome (MDS) treatment can initially worsen patients' clinical condition and they may discontinue therapy before achieving benefit. We present previously unpublished data from two large phase III trials describing common adverse events (AEs) associated with azacitidine and methods to manage them... CONCLUSION: Hematologic and non-hematologic AEs with azacitidine decreased in frequency as treatment continued. Awareness of the onset, duration and management of AEs can facilitate treatment, permitting patients to continue therapy for maximum benefit.

Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C. [2010.04]
In the phase III AZA-001 trial, low-dose cytarabine (LDara-C), the most widely used low-dose chemotherapy in patients with higher-risk myelodysplastic syndrome (MDS) who are ineligible for intensive treatment, was found to be associated with poorer survival compared with azacitidine... When analyzed per patient year of drug exposure, azacitidine treatment was associated with fewer grade 3-4 cytopenias and shorter hospitalisation time than LDara-C in these higher-risk MDS patients.

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Clinical Trials Related to Vidaza (Azacitidine Subcutaneous)

Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck [Terminated]
To evaluate the safety and toxicity of azacitidine (5-azacitidine, VidazaŽ) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).

Ph II Study of Azacitidine in Myelofibrosis [Active, not recruiting]
The goal of this clinical research study is to learn if azacitidine can help to control MF. The safety of azacitidine in patients with MF will also be studied.

Optional Procedures: You will be asked to have additional blood samples and bone marrow samples collected. These samples will be used to evaluate important characteristics of MF before and during the therapy with azacitidine.

Vidaza to Restore Hormone Thx Prostate [Active, not recruiting]
The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in

myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in

this study, Pharmion Corporation, is the manufacturer of Vidaza.

5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia [Recruiting]

Azacitidine and Cisplatin in Patients With Advanced Lung or Head and Neck Cancer [Recruiting]
The standard of care for head and neck and lung cancer includes chemotherapy, radiation and surgery. For patients with cancer of head and neck or lung that recurs after surgery and/or radiation, or has spread to other parts of body, chemotherapy using cisplatin can slow down tumor growth and extend lifespan.

The study drug, azacitidine, can block the ability of some cancer cells to replicate, and has been approved by the Food and Drug Administration for use in myelodysplastic syndrome, which is a slowly developing blood cell-related cancer. In laboratory and animal experiments using head and neck and lung cancer cells, azacitidine has been shown to be a cisplatin "helper", (that is, it makes cisplatin more effective in stopping the growth of head and neck and lung cancer. )

Since the combination of azacitidine and cisplatin has not been used in patients with head and neck or lung cancer, the investigators are performing this study combining azacitidine and cisplatin to find out what effects, good and/or bad, the study drug may have on patients with advanced head and neck or lung cancer. The investigators are doing this study because they would like to find a better treatment for these types of cancer.

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Reports of Suspected Vidaza (Azacitidine Subcutaneous) Side Effects

Pneumonia (173)Febrile Neutropenia (165)Sepsis (163)Death (148)Acute Myeloid Leukaemia (135)Thrombocytopenia (102)Pyrexia (99)Platelet Count Decreased (91)Neutropenia (84)White Blood Cell Count Decreased (75)more >>


Page last updated: 2011-12-09

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