Decitabine (Page 4 of 4)

14.2 Single-arm Studies in Myelodysplastic Syndrome

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 20 mg/m2 as an intravenous infusion over 1-hour daily, on days 1 to 5 of week 1 every 4 weeks (1 cycle). The results were consistent with the results of the controlled trial and are 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) 71±9
Median (Range: min-max) 72 (34 to 87)
Sex n (%)
Male 71 (72)
Female 28 (28)
Race n (%)
White 86 (87)
Black 6 (6)
Asian 4 (4)
Other 3 (3)
Days From MDS Diagnosis to First Dose
Mean (±SD)Median (Range: min-max) 444±626154 (7 to 3079)
Previous MDS Therapy n (%)
Yes 27 (27)
No 72 (73)
RBC Transfusion Status n (%) Independent 33 (33)
Dependent 66 (67)
Platelet Transfusion Status n (%)
Independent 84 (85)
Dependent 15 (15)
IPSS Classification n (%)
Low RiskIntermediate–1Intermediate–2High Risk 1 (1)52 (53)23 (23)23 (23)
FAB Classification n (%)
RA 20 (20)
RARS 17 (17)
RAEB 45 (45)
RAEB-t 6 (6)
CMML 11 (11)
Table 8 Analysis of Response (ITT)*
Parameter Decitabine N = 99

* Cheson BD, Bennett JM, et al. Report of an International Working Group to Standardize Response Criteria for MDS. Blood. 2000; 96:3671 to 3674.

+ indicates censored observation

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 to 267)443 (72 to 722+)


  1. OSHA Hazardous Drugs.” OSHA.


Decitabine for Injection is a sterile white to almost white lyophilized powder for intravenous use supplied as follows:

NDC Decitabine for Injection Package Factor
25021-231-20 50 mg Single-Dose Vial 1 vial per carton

Store vials at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.



Advise patients of the risk of myelosuppression and to report any symptoms of infection, anemia, or bleeding to their healthcare provider as soon as possible. Advise patients for the need for laboratory monitoring [see Warnings and Precautions (5.1)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception while receiving decitabine for injection and for 6 months after last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception while receiving treatment with decitabine for injection and for 3 months after the last dose [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].


Advise women to avoid breastfeeding while receiving decitabine for injection and for at least 2 weeks after the last dose [see Use in Specific Populations (8.2)].

Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India©2023 Sagent Pharmaceuticals

June 2023

SAGENT Pharmaceuticals®


NDC 25021-231-20

Rx only

Decitabine for Injection

50 mg per vial


Single-Dose Sterile Vial

Discard unused portion

Warning: Cytotoxic Agent

(click image for full-size original)
DECITABINE decitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-231
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
decitabine (decitabine) decitabine 50 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
potassium phosphate, monobasic
sodium hydroxide
# Item Code Package Description Multilevel Packaging
1 NDC:25021-231-20 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (25021-231-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205539 08/15/2018
Labeler — Sagent Pharmaceuticals (080579617)

Revised: 06/2023 Sagent Pharmaceuticals

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