- “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 63323-771-39).
Store unreconstituted vials at 25º C (77º F); excursions permitted to 15º-30º C (59º-86º 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)
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)].
Lake Zurich, IL 60047
Made in India
Principal Display Panel – 100 mg Vial Label
For Subcutaneous and
Intravenous Use OnlyRx only
Principal Display Panel – 100 mg Carton
for Injection 100 mg/vial
For Subcutaneous and Intravenous Use Only
One Single-Dose Vial
|AZACITIDINE azacitidine injection, powder, lyophilized, for solution|
|Labeler — Fresenius Kabi USA, LLC (608775388)|
|Shilpa Medicare Limited||650644136||MANUFACTURE (63323-771)|
Revised: 12/2020 Fresenius Kabi USA, LLC
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