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 each containing 60 mg of busulfan at a concentration of 6 mg per mL for intravenous use, NDC 72606-559-01.

Busulfan injection is distributed as a unit carton of eight vials NDC 72606-559-02

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).

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 procedures1.

17 PATIENT COUNSELING INFORMATION

My elosuppression

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)].

Manufactured by:

Shilpa Medicare Limited

S-20 to S-26, Polepally,

Jadcherla, Mahaboobnagar,

Telangana, INDIA — 509301

Distributed by:

CELLTRION USA, INC.

One Evertrust Plaza Suite 1207,

Jersey City, New Jersey,

07302, USA

Revised: 10/2019

image description
(click image for full-size original)

image description
(click image for full-size original)
BUSULFAN busulfan injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72606-559
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:72606-559-02 8 CARTON in 1 CARTON contains a CARTON (72606-559-01)
1 NDC:72606-559-01 1 VIAL, SINGLE-DOSE in 1 CARTON This package is contained within the CARTON (72606-559-02) and contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within a CARTON (72606-559-01) and a CARTON (72606-559-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210931 12/01/2019
Labeler — CELLTRION USA, INC. (116587378)

Revised: 12/2019 CELLTRION USA, INC.

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 © 2024. All Rights Reserved.