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.
|Demographic or Other Patient Characteristic||Decitabine for Injection N = 99|
|Median (Range: min-max)||72 (34 to 87)|
|Sex n (%)|
|Race n (%)|
|Days From MDS Diagnosis to First Dose|
|Median (Range: min-max)||154 (7 to 3079)|
|Previous MDS Therapy n (%)|
|RBC Transfusion Status n (%)|
|Platelet Transfusion Status n (%)|
|IPSS Classification n (%)|
|Low Risk||1 (1)|
|High Risk||23 (23)|
|FAB Classification n (%)|
* 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+)|
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].
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)].
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)]
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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