Prescription Drug Information: Decitabine (Page 4 of 4)

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

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 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