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
- 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
Decitabine-for-Injection-carton-label
| DECITABINE decitabine injection, powder, lyophilized, for solution | |||||||||||||||||
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| 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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