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 63323-771-39).

Storage

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

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)

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)].

Manufactured for:

Fresenius Kabi Logo

Lake Zurich, IL 60047
Made in India
www.fresenius-kabi.com/us
451537C

Revised: 06/2020

4500645

Principal Display Panel – 100 mg Vial Label

NDC 63323-771-39
Azacitidine
for Injection
100 mg/vial

For Subcutaneous and
Intravenous Use OnlyRx only

Single-Dose Vial

Principal Display Panel – 100 mg Vial Label
(click image for full-size original)

Principal Display Panel – 100 mg Carton

NDC 63323-771-39

Azacitidine

for Injection 100 mg/vial

For Subcutaneous and Intravenous Use Only

Rx only

One Single-Dose Vial

Principal Display Panel – 100 mg 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:63323-771
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZACITIDINE (AZACITIDINE) AZACITIDINE 100 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 100 mg in 30 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-771-39 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-771-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207518 03/16/2017
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Shilpa Medicare Limited 650644136 MANUFACTURE (63323-771)

Revised: 12/2020 Fresenius Kabi USA, LLC

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