- “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 68001-313-56).
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.
Hepatic Toxicity in Patients with Severe Pre-Existing Hepatic Impairment
Instruct patients to inform their physician about any underlying liver disease.
Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions ( 5.3)].
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)].
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)].
Manufactured in Romania by:
Sindan Pharma SRL
11 Ion Mihalache Blvd.
Bucharest 1, Romania 011171
For BluePoint Laboratories
Rev. B 04/2020
| AZACITIDINE |
azacitidine injection, powder, lyophilized, for solution
|Labeler — BluePoint Laboratories (985523874)|
|Sindan-Pharma Srl||683754121||ANALYSIS (68001-313), LABEL (68001-313), MANUFACTURE (68001-313), PACK (68001-313)|
Revised: 06/2020 BluePoint Laboratories
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