Mitoxantrone hydrochloride is supplied as a concentrate for injection in multidose vials.2948; 2949 The concentrate must be diluted prior to administration.2948; 2949 Each mL of the dark blue aqueous concentrate contains mitoxantrone 2 mg (as the hydrochloride salt), sodium chloride 0.8%, sodium acetate 0.005%, and acetic acid 0.046%.2948; 2949 Some products also contain sodium metabisulfite 0.01%.2949
pH
Sodium Content
Mitoxantrone hydrochloride concentrate for injection must be diluted for use.2948; 2949 The drug is administered by intravenous infusion after dilution to at least 50 mL in dextrose 5% or sodium chloride 0.9%.2948; 2949 The drug may be further diluted in dextrose 5%; sodium chloride 0.9%; or dextrose 5% in sodium chloride 0.9%.2948; 2949 Mitoxantrone hydrochloride is administered over about 5 to 15 minutes as a short intravenous infusion or 24 hours by continuous intravenous infusion.2948; 2949 The drug should be administered into the tubing of a freely running intravenous solution of sodium chloride 0.9% or dextrose 5%.2948; 2949 The tubing should be attached to a butterfly needle or other suitable device, inserted preferentially into a large vein.2948; 2949 The drug should not be given over less than 3 minutes.2948; 2949
Mitoxantrone hydrochloride should not be administered by other routes (e.g., subcutaneous, intramuscular, intra-arterial, intrathecal).2948; 2949
Intact vials of the dark blue concentrate for injection should be stored upright at controlled room temperature and protected from freezing.2948; 2949 Refrigeration of the concentrate may cause a precipitate, which redissolves upon warming to room temperature.72; 1369
The manufacturers indicate that mitoxantrone hydrochloride concentrate remaining in partially used vials may be stored for up to 7 days at 15 or 20 to 25°C and up to 14 days under refrigeration but should not be frozen.2948; 2949
Combining heparin with mitoxantrone hydrochloride may result in precipitate formation.1293; 2948; 2949
pH Effects
The pH range of maximum stability is 2 to 4.5; the solution was unstable when the pH was increased to 7.4.1379
Light Effects
Mitoxantrone hydrochloride is not photolabile. Exposure of the product to direct sunlight for 1 month caused no change in its appearance or concentration.72; 1293
Syringes
Mitoxantrone hydrochloride 0.2 mg/mL in sodium chloride 0.9% in polypropylene syringes (Braun Omnifix) is reported to be stable for 28 days at 4 and 20°C.1564 Mitoxantrone hydrochloride 0.2 mg/mL in water for injection in polypropylene syringes is reported to be stable for 14 days at 4 and 20°C and for 24 hours at 37°C.1369
Mitoxantrone hydrochloride (Lederle) 2 mg/mL in glass vials and drawn into 12-mL plastic syringes (Monoject) exhibited no visual changes and little or no loss when stored for 42 days at 4 and 23°C. Potential extractable materials from the syringes were not detectable during the study period.1593
Sorption
Mitoxantrone hydrochloride (Lederle) 1 mg/mL in sodium chloride 0.9% exhibited no loss due to sorption to polyvinyl chloride (PVC) and polyethylene administration lines during simulated infusion at 0.875 mL/hr for 2.5 hours via a syringe pump.1795
Filtration
Although binding of mitoxantrone hydrochloride to filters has been reported,1249; 1415; 1416 one manufacturer stated that filtration of mitoxantrone hydrochloride through a 0.22-µm filter (Millipore) resulted in no loss.1293
Mitoxantrone hydrochloride (Lederle) 1 mg/mL in sodium chloride 0.9%, during simulated infusion at 0.875 mL/hr for 2.5 hours via a syringe pump, exhibited no loss due to sorption to cellulose acetate (Minisart 45, Sartorius), polysulfone (Acrodisc 45, Gelman), and nylon (Posidyne ELD96, Pall) filters.1795
For a list of references cited in the text of this monograph, search the monograph titled References.