Blinatumomab is available as a lyophilized powder in preservative-free single-dose vials containing 35 mcg of the drug.3095 Each vial also contains citric acid monohydrate 3.35 mg, lysine hydrochloride 23.23 mg, polysorbate 80 0.64 mg, trehalose dihydrate 95.5 mg, and sodium hydroxide to adjust the pH.3095
Each vial of blinatumomab is packaged with a 10-mL single-dose vial of preservative-free intravenous solution stabilizer.3095 Each vial of intravenous solution stabilizer contains citric acid monohydrate 52.5 mg, lysine hydrochloride 2283.8 mg, polysorbate 80 10 mg, sodium hydroxide (to adjust the pH), and water for injection.3095 The intravenous solution stabilizer is added to the infusion bag to coat the bag prior to the addition of the reconstituted blinatumomab solution, thereby preventing adhesion of the drug to the bag and administration tubing; the solution stabilizer should not be used to reconstitute the drug.3095
The manufacturer states that protective clothing and gloves should be worn in the preparation of blinatumomab.3095 Gloves and surfaces that may have come in contact with the drug during preparation should be disinfected.3095
Because errors have occurred in the preparation of blinatumomab, the manufacturer's instructions for preparation of the drug should be strictly followed to minimize the risk of such errors.3095
To reconstitute a vial of blinatumomab, 3 mL of preservative-free sterile water for injection should be added to the vial containing 35 mcg of the drug.3095 The stream of diluent should be directed along the walls of the vial (not directly into the lyophilized powder), and the vial should be gently swirled to avoid excess foaming.3095 The vial should not be shaken.3095 The concentration of blinatumomab in the reconstituted solution is 12.5 mcg/mL; this solution must be further diluted prior to administration.3095 The reconstituted solution should be clear to slightly opalescent, colorless to slightly yellow.3095 Reconstituted blinatumomab solution should be visually inspected for particulate matter and discoloration; the solution should not be used if it is cloudy or has precipitated.3095
To prepare a blinatumomab solution for infusion for administration over 24 or 48 hours at a rate of 10 or 5 mL/hr, respectively, 270 mL of sodium chloride 0.9% injection should be transferred to an empty polyolefin, diethylhexyl phthalate (DEHP)-free polyvinyl chloride (PVC), or ethyl vinyl acetate (EVA) infusion bag followed by 5.5 mL of intravenous solution stabilizer.3095 The contents of the infusion bag should be mixed gently to avoid foaming.3095 The remaining unused portion of intravenous solution stabilizer should be discarded.3095 The appropriate amount of reconstituted blinatumomab solution should then be transferred to the infusion bag containing the sodium chloride 0.9% and intravenous solution stabilizer, and the contents of the infusion bag again should be mixed gently to avoid foaming.3095
Alternatively, diluted blinatumomab solution for infusion may be administered over 7 days in patients weighing at least 22 kg; this option is not recommended for use in patients weighing less than 22 kg.3095 To prepare a blinatumomab solution for infusion for administration over 7 days at a rate of 0.6 mL/hr, 90 mL of bacteriostatic sodium chloride 0.9% preserved with benzyl alcohol should be transferred to an empty polyolefin, DEHP-free PVC, or EVA infusion bag followed by 2.2 mL of intravenous solution stabilizer.3095 The contents of the infusion bag should be mixed gently to avoid foaming.3095 The remaining unused portion of intravenous solution stabilizer should be discarded.3095 The appropriate amount of reconstituted blinatumomab solution should then be transferred to the infusion bag containing bacteriostatic sodium chloride 0.9% and intravenous solution stabilizer, and the contents of the infusion bag again should be mixed gently to avoid foaming.3095 A sufficient amount of sodium chloride 0.9% should be added to the infusion bag to yield a total volume of 110 mL resulting in a final benzyl alcohol concentration of 0.74%.3095 The contents of the infusion bag again should be mixed gently to avoid foaming.3095
When prepared according to the manufacturer’s directions for administration over 24 hours, 48 hours, or 7 days, the blinatumomab infusion solution will have a greater volume than will be administered to the patient to allow for priming of the line and to ensure that the patient receives the full dose of the drug.3095 Intravenous tubing that is composed of polyolefin, DEHP-free PVC, or EVA and is compatible with the infusion pump used should be attached to the bag containing the diluted blinatumomab solution for infusion.3095 Intravenous tubing used for the administration of a 24- or 48-hour infusion of blinatumomab must contain a low protein-binding 0.2-µm inline filter; intravenous tubing used for the administration of a 7-day infusion does not require an inline filter.3095 Air should be removed from the infusion bag; removal of air from the bag is especially important for use with ambulatory infusion pumps.3095 The attached intravenous tubing should be primed only with the prepared blinatumomab solution for infusion; the tubing should not be primed with sodium chloride 0.9%.3095
Trade Name(s)
Blincyto
Blinatumomab diluted for infusion is administered by continuous infusion, either over 24 or 48 hours at a rate of 10 or 5 mL/hr, respectively, or over 7 days at a rate of 0.6 mL/hr in patients weighing at least 22 kg.3095 The diluted solution for infusion should be administered at a constant rate using a programmable, lockable, non-elastomeric infusion pump equipped with an alarm.3095 Patients should receive appropriate premedication administered prior to blinatumomab infusion when indicated.3095
Because errors have occurred during administration of blinatumomab, the manufacturer's instructions for administration of the drug should be strictly followed to minimize the risk of such errors.3095 The intravenous tubing should be primed only with the prepared blinatumomab solution for infusion; the tubing should not be primed with sodium chloride 0.9%.3095 If a multi-lumen venous catheter is used for administration, the diluted solution of blinatumomab for infusion should be infused through a dedicated lumen.3095 The infusion line or intravenous catheter through which blinatumomab is administered must not be flushed, especially when changing infusion bags.3095 Flushing the line can result in the administration of an excess dose with resulting potential complications.3095 Instead, any unused solution for infusion remaining in the infusion bag or line should be disposed of properly.3095
Blinatumomab is a white to off-white lyophilized powder that forms a clear to slightly opalescent, colorless to slightly yellow solution upon reconstitution.3095 Intact vials of blinatumomab and intravenous solution stabilizer should be stored at 2 to 8°C in the original package to protect from light until the time of use.3095 Vials of both blinatumomab lyophilized powder and intravenous solution stabilizer may be stored for a maximum of 8 hours at room temperature in the original carton to protect from light.3095 Vials should not be frozen.3095
After reconstitution, a vial of blinatumomab may be stored for a maximum of 24 hours at 2 to 8°C or 4 hours at 23 to 27°C.3095
If not used immediately, final diluted solutions of blinatumomab for infusion should be stored at 2 to 8°C.3095 The diluted solution intended for infusion over 24 or 48 hours and prepared with sodium chloride 0.9% may be stored for a maximum of 8 days at 2 to 8°C; if stored at 23 to 27°C, administration of these diluted solutions of blinatumomab must be completed within 48 hours.3095 The diluted solution of blinatumomab intended for infusion over 7 days and prepared with bacteriostatic sodium chloride 0.9% (preserved with benzyl alcohol) may be stored for a maximum of 14 days at 2 to 8°C; if stored at 23 to 27°C, administration of this diluted solution of blinatumomab must be completed within 7 days.3095
Sorption
Intravenous solution stabilizer packaged with blinatumomab is added to the infusion bag to coat the bag prior to the addition of the reconstituted blinatumomab solution, thereby preventing adhesion of the drug to the bag and administration tubing.3095 Only polyolefin, DEHP-free PVC, and EVA infusion bags, pump cassettes, and intravenous tubing should be used in the preparation and administration of blinatumomab.3095
Filtration
Blinatumomab solution for infusion must be administered through polyolefin, DEHP-free PVC, or EVA intravenous tubing.3095 The final diluted solution of blinatumomab intended for infusion over 24 or 48 hours and prepared with sodium chloride 0.9% must be administered through intravenous tubing containing a low protein-binding 0.2-µm inline filter.3095 An inline filter is not required for the administration of a 7-day infusion bag prepared with bacteriostatic sodium chloride 0.9% (preserved with benzyl alcohol).3095
For a list of references cited in the text of this monograph, search the monograph titled References.