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

How Supplied

Azacitidine for injection is supplied as a lyophilized powder in 100 mg single-dose vials packaged in cartons of 1 vial (NDC 16714-927-01).

Storage

Store unreconstituted vials at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature].

Handling and Disposal

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

17 PATIENT COUNSELING INFORMATION

Hepatotoxicity in Patients with Severe Pre-Existing Hepatic Impairment

Instruct patients to inform their physician about any underlying liver disease [see Warnings and Precautions (5.2)].

Renal Toxicity

Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions ( 5.3) and Use in Specific Populations (8.6)].

Embryo-Fetal Risk

Advise pregnant women 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 males with female sexual partners of reproductive potential to not father a child and to use effective contraception during treatment with azacitidine for injection. Advise patients to report pregnancy to their physicians immediately [see Warnings and Precautions (5.5) and Use in Specific Populations (8.3)].

Lactation

Advise patients to avoid breastfeeding while receiving azacitidine for injection [see Use in Specific Populations (8.2)].

Rx only

Mfd. for: Northstar Rx LLC Memphis, TN 38141

Manufactured by:

Dr. Reddy’s Laboratories Limited

Visakhapatnam — 530 046 INDIA

Revised: 0320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Vial Label

Vial
(click image for full-size original)

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

Vial Carton

Carton
(click image for full-size original)

AZACITIDINE azacitidine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-927
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azacitidine (Azacitidine) Azacitidine 100 mg
Inactive Ingredients
Ingredient Name Strength
mannitol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-927-01 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
ANDA ANDA201537 05/08/2019
Labeler — NorthStar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Dr.Reddy’s Laboratories Ltd-FTO 7 650446243 analysis (16714-927), manufacture (16714-927)

Revised: 03/2020 NorthStar RxLLC

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