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 for Injection 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 for Injection 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 for Injection N = 99
Age (years) Mean (±SD)Median (Range: min-max) 71±972 (34-87)
Sex n (%) MaleFemale 71 (72)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 (7-3079)
Previous MDS Therapy n (%) YesNo 27 (27)72 (73)
RBC Transfusion Status n (%) IndependentDependent 33 (33)66 (67)
Platelet Transfusion Status n (%) IndependentDependent 84 (85)15 (15)
IPSS Classification n (%)
Low Risk 1 (1)
Intermediate–1 52 (53)
Intermediate–2 23 (23)
High Risk 23 (23)
FAB Classification n (%) RARARSRAEBRAEB-tCMML 20 (20)17 (17)45 (45)6 (6)11 (11)
Table 8: Analysis of Response (ITT)*

*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

Parameter Decitabine for Injection N=99
Overall Response Rate (CR+PR) 16 (16%)
Complete Response (CR) 15 (15%)
Partial Response (PR) 1 (1%)
Duration of Response 162 (50-267)
Median time to (CR+PR) response — Days (range)
Median Duration of (CR+PR) response — Days (range) 443 (72-722)

15 REFERENCES

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

16 HOW SUPPLIED/STORAGE AND HANDLING

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

NDC Decitabine for Injection Package Factor
70860-219-20 50 mg Single-Dose Vial 1 vial per carton

Storage Conditions

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

Discard unused portion.

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

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 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)].

Lactation

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)].

Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in China©2021 Athenex.

June 2021

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — VIAL LABEL

NDC 70860-219-20

Decitabine for Injection

50 mg per vial

Rx only

FOR INTRAVENOUS INFUSION ONLY

Single-Dose Sterile Vial – Discard Unused Portion.

Caution: Cytotoxic Agent

PACKAGE LABEL -- PRINCIPAL DISPLAY PANEL -- VIAL 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:70860-219
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
monobasic potassium phosphate
sodium hydroxide
hydrochloric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70860-219-20 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70860-219-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212826 08/15/2021
Labeler — Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 07/2021 Athenex Pharmaceutical Division, LLC.

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