Dacogen (Page 4 of 4)

14.2 Single-arm Studies

Three open-label, single-arm, multicenter studies were conducted to evaluate the safety and efficacy of Dacogen 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 Dacogen by intravenous infusion at a dose of 20 mg/m2 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

Dacogen N = 99

Age (years) Mean (±SD)Median (Range: min-max)

71±972 (34-87)

Gender n (%) Male Female

71 (72)28 (28)

Race n (%) WhiteBlackAsianOther

86 (87)6 (6)4 (4)3 (3)

Days From MDS Diagnosis to First Dose Mean (±SD)Median (Range: min-max)

444±626154 (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 (%) IndependentDependent

84 (85)15 (15)

IPSS Classification n (%) Low RiskIntermediate–1Intermediate–2 High Risk

1 (1)52 (53)23 (23)23 (23)

FAB Classification n (%) RARARS RAEB RAEB-tCMML

20 (20)17 (17)45 (45)6 (6)11 (11)

Table 8 Analysis of Response (ITT)*

Parameter

Dacogen N=99

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+)

+ 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.

15 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC 62856-600-01, 50 mg single-dose vial individually packaged in a carton.

Storage
Store vials at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

17 PATIENT COUNSELING INFORMATION

Instructions for Patients

Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Dacogen and for I 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 Dacogen, 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)].

Eisai Inc.
Manufactured by Pharmachemie B.V. Haarlem, The Netherlands
Manufactured for Eisai Inc., Woodcliff Lake, NJ 07677

Dacogen® is a registered trademark of Astex Pharmaceuticals, Inc.,
Dublin, CA, U.S.A. used under license.

PRINCIPAL DISPLAY PANEL

NDC 62856-600-01

DACOGEN®
decitabine for injection
50 mg per vial

FOR INTRAVENOUS USE ONLY
WARNING: Cytotoxic AgentSingle use sterile vial

Rx ONLY

dacogen-03
(click image for full-size original)
DACOGEN decitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-600
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 Multilevel Packaging
1 NDC:62856-600-01 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (62856-600-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021790 05/03/1996
Labeler — Eisai Inc. (831600833)
Establishment
Name Address ID/FEI Operations
Pharmachemie B.V. 402108922 MANUFACTURE (62856-600)

Revised: 02/2014 Eisai Inc.

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