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PMS-BUSULFAN is a brand name for Busulfan, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE pms-BUSULFAN (busulfan) injection is indicated for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation, including: acute lymphocytic leukemia, acute non-lymphocytic leukemia, acute myeloid leukemia,…
Verbatim from this product's HC label. Tap a section to expand.
pms-BUSULFAN (busulfan) should be administered intravenously via a central venous catheter as a two-hour infusion every 6 hours x 4 consecutive days for a total of 16 doses. All patients should be premedicated with anticonvulsants, such as phenytoin, to prevent seizures, as busulfan is known to cross the blood brain barrier.
Antiemetics of the 5-HT3 class should be administered prior to the first dose of pms-BUSULFAN and continued on a fixed schedule through administration of pms-BUSULFAN or considered through completion of the preparative regimen. 8 mg/kg of ideal body weight or actual body weight, whichever is lower.
For obese or severely obese patients, dosing based on adjusted ideal body weight could be considered. 91 x (height -152). 25 x (actual weight - IBW). Cyclophosphamide in combination with pms-BUSULFAN was given on each of two days as a one-hour infusion at 60 mg/kg beginning on BMT day -3, no sooner than six hours following the 16th dose of pms-BUSULFAN.
Based on the literature evidence, there appears to be safety benefits in patients with hematologic malignancies receiving cyclophosphamide 6 hours or more following pms-BUSULFAN. 3 g/mol Structural formula: Description: Busulfan is a white crystalline powder that is only very slightly soluble in water, slightly soluble in ethanol (96%), and freely soluble in acetone and acetonitrile.
The pH profile is not applicable since the drug product is only very slightly soluble in water.
Melting Range: 115ºC - 118ºC Composition Active Ingredient:
Each 10-mL single-use vial contains 60 mg busulfan, USP. 667 mL, respectively. The vial stopper is free of natural rubber latex. pms-BUSULFAN Product Monograph Page 16 of 30 Stability and Storage Recommendations Unopened vials of pms-BUSULFAN injection must be stored under refrigerated conditions between 2°C - 8ºC.
9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25ºC) for up to 8 hours but the infusion must be completed within that time. 9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2ºC - 8ºC) for up to 12 hours but the infusion must be completed within that time.
FREEZING OF DILUTED PREPARATIONS OF PMS-BUSULFAN IS NOT RECOMMENDED. Reconstituted Solutions Preparation for Intravenous Administration As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration and leakage prior to administration, whenever solution and container permit.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Busulfan in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Discard unused portion. 9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (D5W). 5 mg/mL. 3 mL busulfan (56 mg total dose). 54 mg/mL). All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood while wearing gloves and protective clothing.
Using a syringe fitted with a needle, remove the calculated volume of busulfan injection from the vial and dispense the contents of the syringe into an intravenous bag (or syringe) that already contains the calculated amount of either normal saline or D5W, making sure that the drug flows into and through the solution.
DO NOT put the busulfan injection into an intravenous bag that does not contain normal saline or D5W. Always add the busulfan to the diluent, not the diluent to the busulfan. Mix thoroughly by inverting several times. Infusion pumps should be used to administer the diluted busulfan solution.
Set the flow rate of the pump to deliver the entire prescribed busulfan dose over two hours. 9% Sodium Chloride Injection, pms-BUSULFAN Product Monograph Page 17 of 30 USP or 5% Dextrose Injection, USP. DO NOT infuse concomitantly with another intravenous solution of unknown compatibility.
WARNING:
PMS-BUSULFAN SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION OR BOLUS. 5 mg By way of example, for a 70-kg patient, the amount of drug to be administered would be calculated as follows: […]