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 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 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)Median (Range: min-max) | 444±626154 (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 RiskIntermediate–1Intermediate–2High Risk | 1 (1)52 (53)23 (23)23 (23) |
| FAB Classification n (%) | |
| RA | 20 (20) |
| RARS | 17 (17) |
| RAEB | 45 (45) |
| RAEB-t | 6 (6) |
| CMML | 11 (11) |
| Parameter | Decitabine N = 99 |
|---|---|
| * Cheson BD, Bennett JM, et al. Report of an International Working Group to Standardize Response Criteria for MDS. Blood. 2000; 96:3671 to 3674. | |
| + indicates censored observation | |
| 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 to 267)443 (72 to 722+) |
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 powder for intravenous use supplied as follows:
| NDC | Decitabine for Injection | Package Factor |
| 25021-231-20 | 50 mg Single-Dose Vial | 1 vial per carton |
Store vials at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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)].
SAGENT®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India©2023 Sagent Pharmaceuticals
June 2023
SAGENT Pharmaceuticals®
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 25021-231-20
Rx only
Decitabine for Injection
50 mg per vial
FOR INTRAVENOUS INFUSION ONLY
Single-Dose Sterile Vial
Discard unused portion
Warning: Cytotoxic Agent
| DECITABINE decitabine injection, powder, lyophilized, for solution | |||||||||||||||||
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| Labeler — Sagent Pharmaceuticals (080579617) |
Revised: 06/2023 Sagent Pharmaceuticals
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