Decitabine (Page 4 of 5)

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 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 for Injection 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) 444±626
Median (Range: min-max) 154 (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 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)*

* 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
Median time to (CR+PR) response — Days (range) 162 (50 to 267)
Median Duration of (CR+PR) response — Days (range) 443 (72 to 722+)

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 powder for intravenous use supplied as:

NDC 64679-067-02, Decitabine for Injection 50 mg single-dose vial individually packaged in a carton.

Store vials at 20°C to 25°C (68 °F to 77°F); excursions permitted between 15°C to 30°C (59°F 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 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 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)]

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Rev: 11/2020

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