Busulfan (Page 6 of 6)

15 REFERENCES

1. OSHA Hazardous Drugs. OSHA. [Accessed on June 18, 2014 from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Busulfan Injection is packaged as a sterile solution in 10 mL single-dose clear glass vials, NDC 67457-893-00.

Busulfan Injection is distributed as a unit carton of eight vials, NDC 67457-893-08.

16.2 Storage and Handling

Unopened vials of busulfan injection must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F). Discard unused portion.

Busulfan injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time.

Busulfan injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time.

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

17 PATIENT COUNSELING INFORMATION

Myelosuppression

Advise patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if fever develops [see Warnings and Precautions (5.1)].

Seizures

Advise patients of the possibility of seizures and that they will be given medication to prevent them. Patients should be asked to report a history of seizure or head trauma [see Warnings and Precautions (5.2)].

Hepatic Veno-Occlusive Disease (HVOD)

Advise patients of the risks associated with the use of busulfan injection as well as the plan for regular blood monitoring during therapy. Specifically inform patients of the following: The risk of veno-occlusive liver disease [see Warnings and Precautions (5.3)].

Embryo-fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1)].

Females of Reproductive Potential

Advise females of reproductive potential to use effective contraception during treatment with busulfan injection and for 6 months following cessation of therapy [see Use in Specific Populations (8.3)].

Males of Reproductive Potential

Advise males with female sexual partners of reproductive potential to use effective contraception during treatment with busulfan injection and for 3 months following cessation of therapy [see Use in Specific Populations (8.3)].

Lactation

Advise females to discontinue breastfeeding during treatment with busulfan injection [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of reproductive potential that busulfan injection may cause temporary or permanent infertility [see Use in Specific Populations (8.3)].

Cardiac Tamponade

Advise patients of the risk of cardiac tamponade. Instruct patients to report to their healthcare provider symptoms of abdominal pain and vomiting [see Warnings and Precautions (5.5)].

Bronchopulmonary Dysplasia

Advise patients of the possibility of bronchopulmonary dysplasia with pulmonary fibrosis with chronic busulfan injection therapy. Instruct patients to report symptoms of shortness of breath and cough to their healthcare provider. These symptoms could occur several months or years after therapy with busulfan injection [see Warnings and Precautions (5.6)].

The brands listed are trademarks of their respective owners.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Intas Pharmaceuticals Ltd.
Gujarat, India

INP030
10 2092 3 6004442

Revised: 8/2020
IPL:BUSUIJ:R4

PRINCIPAL DISPLAY PANEL – 60 mg/10 mL

NDC 67457-893-08 Rx only

Busulfan
Injection
60 mg/10 mL (6 mg/mL)

For Intravenous Infusion Only

Caution: Must be diluted before use.

Cytotoxic Agent

Sterile

Discard Unused Portion

Contains: Eight 10 mL Single-Dose Vials

Each vial contains:
60 mg busulfan, USP
3.3 mL dimethylacetamide
6.7 mL polyethylene glycol-400, NF

Dosage and Administration:
See package insert.

Store refrigerated between
2° to 8°C (36° to 46°F).

Code: Guj/Drugs/1026

Manufactured for:
Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in India

IPL:893:8C:R2

Mylan.com

Busulfan Injection 60 mg/10 mL Carton Label
(click image for full-size original)
BUSULFAN busulfan injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-893
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSULFAN (BUSULFAN) BUSULFAN 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
N,N-DIMETHYLACETAMIDE
POLYETHYLENE GLYCOL 400
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-893-08 8 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (67457-893-00)
1 NDC:67457-893-00 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (67457-893-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208536 11/21/2017
Labeler — Mylan Institutional LLC (790384502)

Revised: 08/2020 Mylan Institutional LLC

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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.