"The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases."...
DOSAGE AND ADMINISTRATION
Initial Dosing Information
- Administer BUSULFEX in combination with cyclophosphamide
as a conditioning regimen prior to bone marrow or peripheral blood progenitor
cell replacement. For patients weighing more than 12 kg, the recommended doses
- BUSULFEX 0.8 mg per kg (ideal body weight or actual body weight, whichever is lower) intravenously via a central venous catheter as a two-hour infusion every six hours for four consecutive days for a total of 16 doses (Days -7, -6, -5 and -4).
- Cyclophosphamide 60 mg per kg intravenously as a one-hour infusion on each of two days beginning no sooner than six hours following the 16th dose of BUSULFEX (Days -3 and -2).
- Administer hematopoietic progenitor cells on Day 0.
- Premedicate patients with anticonvulsants (e.g., benzodiazepines, phenytoin, valproic acid or levetiracetam) to prevent seizures reported with the use of high dose BUSULFEX. Administer anticonvulsants 12 hours prior to BUSULFEX to 24 hours after the last dose of BUSULFEX. [see WARNINGS AND PRECAUTIONS]
- Administer antiemetics prior to the first dose of BUSULFEX and continue on a fixed schedule through BUSULFEX administration.
- BUSULFEX clearance is best predicted when the BUSULFEX
dose is administered based on adjusted ideal body weight. Dosing BUSULFEX based
on actual body weight, ideal body weight or other factors can produce
significant differences in BUSULFEX clearance among lean, normal and obese
- Calculate ideal body weight (IBW) as follows (height in
cm, and weight in kg):
Men: IBW (kg)=50+0.91x (height in cm -152)
Women: IBW (kg)=45+0.91x (height in cm -152)
- For obese or severely obese patients, base BUSULFEX dosing on adjusted ideal body weight (AIBW): AIBW= IBW +0.25x (actual weight -IBW).
- Calculate ideal body weight (IBW) as follows (height in cm, and weight in kg):
Preparation And Administration Precautions
DO NOT USE POLYCARBONATE SYRINGES OR POLYCARBONATE FILTER NEEDLES WITH BUSULFEX.
Use an administration set with minimal residual hold-up volume (2-5 cc) for product administration.
BUSULFEX is a cytotoxic drug. Follow applicable special handling and disposal procedures. Skin reactions may occur with accidental exposure. Use gloves when preparing BUSULFEX. If BUSULFEX or diluted BUSULFEX solution contacts the skin or mucosa, wash the skin or mucosa thoroughly with water.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not use if particulate matter is seen in the BUSULFEX vial.
Preparation For Intravenous Administration
BUSULFEX must be diluted prior to intravenous infusion with either 0.9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (D5W). The diluent quantity should be 10 times the volume of BUSULFEX, so that the final concentration of busulfan is approximately 0.5 mg per mL. Calculation of the dose for a 70 kg patient would be performed as follows:
(70 kg patient) x (0.8 mg per kg) ÷ (6 mg per mL) =9.3 mL BUSULFEX (56 mg total dose).
To prepare the final solution for infusion, add 9.3 mL of BUSULFEX to 93 mL of diluent (normal saline or D5W) as calculated below:
(9.3 mL BUSULFEX) x (10) =93 mL of either diluent plus the 9.3 mL of BUSULFEX to yield a final concentration of busulfan of 0.54 mg per mL (9.3 mL x 6 mg per mL ÷ 102.3 mL =0.54 mg per mL).
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood while wearing gloves and protective clothing.
DO NOT put the BUSULFEX into an intravenous bag or large-volume syringe that does not contain normal saline or D5W. Always add the BUSULFEX to the diluent, not the diluent to the BUSULFEX. Mix thoroughly by inverting several times.
Infusion pumps should be used to administer the diluted BUSULFEX solution. Set the flow rate of the pump to deliver the entire prescribed BUSULFEX dose over two hours. Prior to and following each infusion, flush the indwelling catheter line with approximately 5 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. DO NOT infuse concomitantly with another intravenous solution of unknown compatibility. WARNING: RAPID INFUSION OF BUSULFEX HAS NOT BEEN TESTED AND IS NOT RECOMMENDED.
Dosage Forms And Strengths
BUSULFEX Injection is supplied as a clear, colorless, sterile, solution in 10 mL single use vial containing 60 mg of busulfan at a concentration of 6 mg per mL for intravenous use only.
Storage And Handling
BUSULFEX is packaged as a sterile solution in 10 mL single-use clear glass vials each containing 60 mg of busulfan at a concentration of 6 mg per mL for intravenous use, NDC 59148-070-90.
BUSULFEX is distributed as a unit carton of eight vials NDC 59148-070-91.
Storage And Handling
Unopened vials of BUSULFEX must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F).
BUSULFEX 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.
BUSULFEX 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.
BUSULFEX is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
1. OSHA Hazardous Drugs. OSHA. [Accessed on June 18, 2014 from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834. Revision Date: January 2015. Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan. Revised: 01/2015
Last reviewed on RxList: 1/28/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Busulfex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.