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
BUSULFAN busulfan injection | |||||||||||||||||||||
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Labeler — CELLTRION USA, INC. (116587378) |
Revised: 12/2019 CELLTRION USA, INC.
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