Table 6. Effect of Azacitidine on RBC Transfusions in MDS Patients 1A patient was considered RBC transfusion independent during the treatment period if the patient had no RBC transfusions during any 56 consecutive days or more during the treatment period. Otherwise, the patient was considered transfusion dependent.
 
Efficacy Parameter Azacitidine plus BSC (n= 179) Conventional Care Regimens
(n= 179)
Number and percent of patients who were transfusion dependent at baseline who became transfusion independent on treatment1 50/111 (45.0%) 13/114 (11.4%)
 (95% CI: 35.6%, 54.8%)
 (95% CI: 6.2%, 18.7%)
Number and percent of patients who were transfusion-independent at baseline who became transfusion-dependent on treatment 10/68 (14.7%)
 28/65 (43.1%)
 
(95% CI: 7.3%, 25.4%)
 (95% CI: 30.9%, 56.0%)

15 REFERENCES
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. (2006) 63:1172-1193.
Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied

VIDAZA (azacitidine for injection) is supplied as a lyophilized powder in 100 mg single-use vials packaged in cartons of 1 vial (NDC 59572-102-01).

Storage

Store unreconstituted vials at 25º C (77º F); excursions permitted to 15º-30º C (59º-86º F) (See USP Controlled Room Temperature).

Handling and Disposal

Procedures for proper handling and disposal of anticancer drugs should be applied. Several guidelines on this subject have been published.1-4 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

17 PATIENT COUNSELING INFORMATION
Instruct patients to inform their physician about any underlying liver or renal disease.

Advise women of childbearing potential to avoid becoming pregnant while receiving treatment with VIDAZA. For nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.
Advise men not to father a child while receiving treatment with VIDAZA.
Manufactured for: Celgene Corporation
Summit, NJ 07901
Manufactured by: Ben Venue Laboratories, Inc.
 Bedford, OH 44146

 Or

Baxter Oncology GmbH
33790 Halle/Westfalen Germany
VIDAZA® is a registered trademark of Celgene Corporation.
©2004-2011 Celgene Corporation, All Rights Reserved.
Package Label - Principal Display Panel - 100 mg Vial Label

Package Label - Principal Display Panel - 100 mg Carton Label

VIDAZA
azacitidine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item C