Azacitidine (Page 5 of 5)

15 REFERENCES

1.
“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

Azacitidine for Injection is supplied as a lyophilized powder in 100 mg single-dose vials packaged in cartons of 1 vial (NDC 68001-313-56).

Storage

Store unreconstituted vials at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Discard unused portion.

Handling and Disposal

Azacitidine for Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Sterile, Nonpyrogenic, Preservative-free.

This vial stopper is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Hepatic Toxicity in Patients with Severe Pre-Existing Hepatic Impairment

Instruct patients to inform their physician about any underlying liver disease.

Renal Toxicity

Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions ( 5.3)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to avoid pregnancy during treatment with Azacitidine for Injection. Advise females of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 6 months after the final dose [see Use in Specific Populations (8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 3 months after the final dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with Azacitidine for Injection and for 1 week after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise males and females of the potential for reduced fertility from Azacitidine for Injection [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].

Manufactured in Romania by:
Sindan Pharma SRL
11 Ion Mihalache Blvd.
Bucharest 1, Romania 011171

For BluePoint Laboratories

Rev. B 04/2020

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Azacitidine Inj_100mg_Rev 09-16_BluePoint Label -- Approved
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Azacitidine Carton Rev 04-17
(click image for full-size original)
AZACITIDINE
azacitidine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-313
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZACITIDINE (AZACITIDINE) AZACITIDINE 100 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-313-56 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208216 07/01/2017
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Sindan-Pharma Srl 683754121 ANALYSIS (68001-313), LABEL (68001-313), MANUFACTURE (68001-313), PACK (68001-313)

Revised: 06/2020 BluePoint Laboratories

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.