Decitabine (Page 5 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 1to 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±9 72 (34-87)

Gender n (%) Male Female

71 (72)28 (28)

Race n (%) White Black Asian Other

86 (87) 6 (6) 4 (4) 3 (3)

Days from MDS Diagnosis to First Dose Mean (±SD) Median (Range: min-max)

444±626 154 (7 to 3079)

Previous MDS Therapy n (%) Yes No

27 (27) 72 (73)

RBC Transfusion Status n (%) Independent Dependent

33 (33) 66 (67)

Platelet Transfusion Status n (%) Independent Dependent

84 (85) 15 (15)

IPSS Classification n (%) Low Risk Intermediate-1 Intermediate-2 High Risk

1 (1) 52 (53) 23 (23) 23 (23)

FAB Classification n (%) RA RARS RAEB RAEB-t CMML

20 (20) 17 (17) 45 (45) 6 (6)11 (11)

Table 8 Analysis of Response (ITT)

Parameter

Decitabine for Injection 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 to 267)

443 (72 to 722+)

+ indicates censored observation

* Cheson BD, Bennett JM, et al. Report of an International Working Group to Standardize Response Criteria for MDS. Blood. 2000; 96:3671-3674.

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 68001-422-37, 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 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) ].

Manufactured by:

Chemi Pharma Ltd

HHF014 Halfar Industrial Estate,

Halfar, Birzebbugia, BBG3000

Malta,

Manufactured for:

BluePoint Laboratories

Rev.04-2020-01

PRINCIPAL DISPLAY PANEL

NDC 68001-422-37
Rx ONLY
DECITABINE for Injection
50 mg per vial
FOR INTRAVENOUS USE ONLY
WARNING: Cytotoxic Agent
Single use sterile vial
Each vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate and 11.6 mg sodium hydroxide.
See package insert and/or carton for detailed indications, reconstitution information, dosage information, and precautions.
Store at 25°C (77°F) (see insert)
Manufactured by:
Chemi Pharma Ltd ,
HHF014 Halfar Industrial Estate,
Halfar, Birzebbugia, BBG3000,

Malta

Manufactured for:

BluePoint Laboratories
Rev 04/2020

Decitabine for Injection 50mg/Vial Vial Label Rev 04/2020
(click image for full-size original)

NDC 68001-422-37
DECITABINE for Injection
50 mg per vial
FOR INTRAVENOUS USE ONLY
WARNING: Cytotoxic Agent
Single use sterile vial
Rx ONLY
BluePoint Laboratories
See bottom flap for batch number and expiration date.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Storage: Store vials at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F)
[See USP Controlled Room Temperature]


Manufactured by:
Chemi Pharma Ltd ,
HHF014 Halfar Industrial Estate,
Halfar, Birzebbugia, BBG3000,

Malta

Manufactured for:

BluePoint Laboratories
Rev 04/2020
Each vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate and 11.6 mg sodium hydroxide.
Reconstitution: Aseptically reconstitute with 10 mL of Sterile Water for Injection USP: each mL will contain 5 mg of decitabine.
Final Concentration: The resultant solution will have a 5 mg per mL (5 mg/mL) concentration and pH of 6.7 to 7.3.
Stability: Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2°C to 8°C) infusion fluids and stored at 2°C to 8°C (36°F to 46°F) for up to a maximum of 7 hours until administration.
See package insert for detailed indications, reconstitution information, dosage information, and precautions.
batch no.:
exp. date:

Decitabine for Injection 50mg/vial Carton Rev 04/2020
(click image for full-size original)
DECITABINE decitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-422
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
potassium phosphate, monobasic
Sodium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-422-37 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 20 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (68001-422-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206033 10/21/2019
Labeler — BluePoint Laboratories (985523874)
Registrant — Chemi SpA (432435238)
Establishment
Name Address ID/FEI Operations
Chemi Pharma Ltd 565562764 MANUFACTURE (68001-422)

Revised: 05/2020 BluePoint Laboratories

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