an in depth [1%),:<5% myeloblasts No dysplastic changes Peripheral Blood In all samples during response: Hgb> 11 g/dL (no transfusions or erythropoietin ANC 1500/μL (no growth factor) Platelets 100,000/ μL (no thrombopoietic agent) No blasts and no dysplasia Partial Response (PR) 8 weeks Bone Marrow On repeat aspirates: 50% decrease in blasts over pretreatment values OR Improvement to a less advanced MDS FAB classification Peripheral Blood Same as for CR The overall response rate (CR+PR) in the ITT population was 17% in Decitabine-treated patients and 0% in the SC group (p <0.001). ( See Table 6 ) The overall response rate was 21% (12/56) in Decitabine-treated patients considered evaluable for response (i.e., those patients with pathologically confirmed MDS at baseline who received at least 2 cycles of treatment). The median duration of response (range) for patients who responded to Decitabine was 288 days (116-388) and median time to response (range) was 93 days (55-272). All but one of the Decitabine-treated patients who responded did so by the fourth cycle. Benefit was seen in an additional 13% of Decitabine-treated patients who had hematologic improvement, defined as a response less than PR lasting at least 8 weeks, compared to 7% of SC patients. Decitabine treatment did not significantly delay the median time to AML or death versus supportive care. Table 6 Analysis of Response (ITT) Parameter Decitabine N=89 Supportive Care N=81 ** p-value> <0.001 from two-sided Fisher's Exact Test comparing Decitabine vs. Supportive Care. + In the statistical analysis plan, a p-value of 0.024 was required to achieve statistical significance. All patients with a CR or PR were RBC and platelet transfusion independent in the absence of growth factors. Responses occurred in patients with an adjudicated baseline diagnosis of AML. Overall Response Rate (CR+PR) + Complete Response (CR) Partial Response (PR) 15 (17%) ** 8 (9%) 7 (8%) 0 (0%) 0 (0%) 0 (0%) Duration of Response Median time to (CR+PR) response - Days (range) Median Duration of (CR+PR) response - Days (range) 93 (55-272) 288 (116-388) NA NA Single-arm Studies Three open-label, single-arm, multicenter studies were conducted to evaluate the safety and efficacy of Decitabine in MDS patients with any of the FAB subtypes. In one study conducted in North America, 99 patients with IPSS Intermediate-1, Intermediate-2, or high risk prognostic scores received Decitabine by intravenous infusion at a dose of 20 mg/m 2 IV over 1-hour daily, on days 1-5 of week 1 every 4 weeks (1 cycle). The results were consistent with the results of the controlled trial and summarized in Table 8. Table 7 Baseline Demographics and Other Patient Characteristics (ITT) Demographic or Other Patient Characteristic Decitabine N = 99 Age (years) Mean ( SD) Median (Range: min-max) 71 9 72 (34-87) Gender n (%) Male Female 71 (72) 28 (28) Race n (%) White Black Asian Other 86 (87) 6 (6) 4 (4) 3 (3) Days From MDS Diagnosis to First Dose Mean ( SD) Median (Range: min-max) 444 626 154 (7-3079) Previous MDS Therapy n (%) Yes No 27 (27) 72 (73) RBC Transfusion Status n (%) Independent Dependent 33 (33) 66 (67) Platelet Transfusion Status n (%) Independent Dependent 84 (85) 15 (15) IPSS Classification n (%) Low Risk Intermediate-1 Intermediate-2 High Risk 1 (1) 52 (53) 23 (23) 23 (23) FAB Classification n (%) RA RARS RAEB RAEB-t CMML 20 (20) 17 (17) 45 (45) 6 (6) 11 (11) Table 8 Analysis of Response (ITT) Parameter Decitabine N=99 + indicates censored observation * Cheson BD, Bennett JM, et al. Report of an International Working Group to Standardize Response Criteria for MDS. Blood . 2000; 96:3671-3674. Overall Response Rate (CR+PR) Complete Response (CR) Partial Response (PR) 16 (16%) 15 (15%) 1 (1%) Duration of Response Median time to (CR+PR) response - Days (range) Median Duration of (CR+PR) response - Days (range) 162 (50-267) 443 (72-722+) REFERENCES 1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. 2. 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 3. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J Health-Syst Pharm . 2006;63:1172-1193. 4. Polovich M., White JM, Kelleher LO (eds). Chemotherapy and biotherapy guidelines and recommendations for practice (2nd ed.) 2005. Pittsburgh, PA: Oncology Nursing Society. HOW SUPPLIED/STORAGE AND HANDLING NDC 16729-224-05, 50 mg single-dose vial individually packaged in a carton. Storage Store vials at 25 C (77 F); [See USP Controlled Room Temperature] excursions permitted to l5 C to 30 C (59 F to 86 F). PATIENT COUNSELING INFORMATION Instructions for Patients Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Decitabine for Injection and for 1 month afterwards, and to use effective contraception during this time, [See Warnings and Precautions ( 5.3 )]. Men should be advised not to father a child while receiving treatment with Decitabine for Injection, and for 2 months afterwards. During these times, men with female partners of childbearing potential should use effective contraception [See Warnings and Precautions ( 5.4 ) and Nonclinical Toxicology ( 13.1 )]. Patients should be advised to monitor and report any symptoms of neutropenia, thrombocytopenia, or fever to their physician as soon as possible [See Warnings and Precautions ( 5.1 )]. Manufactured For Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: Intas Pharmaceuticals Limited. Plot No. 5, 6 & 7, Pharmez, Sarkhej-Bavla, National Highway No. 8-A, Near Village Matoda, Tal Sanand, Ahmedabad - 382 213, Gujarat, India 51 2196 0 700602 Issued January, 2016. PRINCIPAL DISPLAY PANEL NDC -16729- 224 -05 Decitabine for Injection 50 mg per vial-label FOR INTRAVENOUS INFUSION ONLY Rx only NDC -16729- 224 -05 Decitabine for Injection 50 mg per vial-carton FOR INTRAVENOUS INFUSION ONLY Rx only Decitabine Decitabine injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16729-224 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Decitabine (Decitabine) Decitabine 50 mg in 20 mL Inactive Ingredients Ingredient Name Strength POTASSIUM PHOSPHATE, MONOBASIC SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:16729-224-05 1 VIAL in 1 CARTON 1 20 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203475 03/08/2017 Labeler - Accord Healthcare Inc. (604222237) Registrant - Accord Healthcare Inc. (604222237) Establishment Name Address ID/FEI Operations Intas Pharmaceuticals Limited 915837971 manufacture(16729-224), analysis(16729-224) Revised: 03/2017 Accord Healthcare Inc. Next Interactions Print this page Add to My Med List More about decitabine Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: antimetabolites Consumer resources Decitabine Decitabine Intravenous (Advanced Reading) Professional resources Decitabine (AHFS Monograph) Decitabine (Wolters Kluwer) Other brands: Dacogen Related treatment guides Acute Myeloid Leukemia Myelodysplastic Syndrome> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Dr. Reddy's Laboratories, Inc. Sun Pharmaceutical Industries Inc. 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