Prescription Drug Information: 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 1-5 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 (34-87)
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) 444±626
Median (Range: min-max) 154 (7-3079)
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 Risk 1 (1)
Intermediate–1 52 (53)
Intermediate–2 23 (23)
High Risk 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
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)

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

15 REFERENCES

  1. OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

Decitabine for injection is a sterile, white to almost white Lyophilized cake or powder for intravenous use supplied as:
NDC 69539-115-01, 50 mg single-dose vial individually packaged in a carton.

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

17 PATIENT COUNSELING INFORMATION

Myelosuppression
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 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 and for 3 months after the last dose [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].
Lactation
Advise women to avoid breastfeeding while receiving decitabine and for at least 2 weeks after the last dose [see Use in Specific Populations (8.2)].
Manufactured by:
MSN Laboratories Private Limited
Telangana – 509 216,
INDIA
Distributed by:
MSN Pharmaceuticals Inc.
Piscataway, NJ 08854 -3714
Issued on: 08/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Decitabine-for-Injection-vial-label

vial-label
(click image for full-size original)

Decitabine-for-Injection-carton-label
crtn-label
(click image for full-size original)

DECITABINE decitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69539-115
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
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69539-115-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 20 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (69539-115-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212265 08/28/2019
Labeler — MSN LABORATORIES PRIVATE LIMITED (650786952)
Establishment
Name Address ID/FEI Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS (69539-115), MANUFACTURE (69539-115)

Revised: 09/2020 MSN LABORATORIES PRIVATE LIMITED

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