- “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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).
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
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)].
Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions ( 5.3) and Use in Specific Populations (8.6)].
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)].
Advise patients to avoid breastfeeding while receiving azacitidine for injection [see Use in Specific Populations (8.2)].
Mfd. for: Northstar Rx LLC Memphis, TN 38141
Dr. Reddy’s Laboratories Limited
Visakhapatnam — 530 046 INDIA
Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
|AZACITIDINE azacitidine injection, powder, lyophilized, for solution|
|Labeler — NorthStar RxLLC (830546433)|
|Dr.Reddy’s Laboratories Ltd-FTO 7||650446243||analysis (16714-927), manufacture (16714-927)|
Revised: 03/2020 NorthStar RxLLC
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.