- Investigational for treatment of newly diagnosed B acute lymphoblastic leukemia in children
- Treatment of relapsed B acute lymphoblastic leukemia
- Available as sterile lyophilized powder containing 38.5 mcg/vial. Preservative free.
- Comes with an IV solution stabilizer, 10 mL single-use vials. DO NOT RECONSTITUTE DRUG WITH STABILIZER.
- Store vials & stabilizer in the refrigerator [2°-8°C]. Protect from light.
- Attach protector (P14) to the vial.
- Reconstitute blinatumomab lyophilized powder (38.5 mcg/vial)
- Attach needle to appropriate size syringe, draw up 3mL of sterile water for injection, remove needle, and attach injector N35 to the syringe
- Add the 3 mL of Sterile Water for Injection (SWFI) to the vial to yield 3.1 mL of blinatumomab at a final concentration of 12.5 mcg/mL
- Rotate the vial to dissolve all powder. Do not shake.
- The stability of the reconstituted vial is 4 hours at room temperature (23°C – 27°C) or 24 hours refrigerated at 2° – 8°C.
- Bag preparation (use worksheet): Must be prepared in the following order (do not deviate from this order; refer to the table in the protocol for volume details):
- Add the appropriate amount of 0.9% NaCl into the IV bag
- Attach the infusion adapter (C100) to the bag
- Clamp the tubing line, then insert into the infusion adaptor port
- Add the IV solution stabilizer for blinatumomab to the IV bag via port with needle (at this point, remove all air from bag)
- Add the calculated dose (mL) of blinatumomab into the solution in the IV bag
- Rotate the IV bag to mix the solution thoroughly. Do not shake. Avoid foaming the IV bag.
- Visually inspect for floating particles or discoloration of the IV solution. If floaters or discoloration is present, do not use the prepared solution.
- The total volume of blinatumomab IV solution will account for the volume of the IV infusion set for the inpatient or outpatient setting.
- Attach a luer lock connector to the end of the line. Luer lock a syringe to this connector
- Open the tubing clamp and push on bag to prime the line. Once the tubing is completely primed, pull plunger of syringe to remove air bubbles from line clamp tubing. Remove connector and attach injector to end of line.
- The solution that was removed from the line in the syringe is returned to the bag by attaching an injector to the syringe and pushing contents of syringe into bag via infusion adaptor.
Final prepared IV solution is stable for 8 days in the refrigerator. Once at room temperature, stable for 96 hours (total refrigerator + room temperature time must not exceed 8 days)
- Solutions Compatible: 0.9% sodium chloride
- DO NOT mix with any other drugs
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
|IV Intermittent Infusion||NO|
|IV Continuous Infusion||YES
Infusion time: 5 mL/hr continuously x 28 days
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- 15 mcg/m2/day (max: 28mcg/day) IV x 28 days per 35 day cycle
- Salvage therapy: Cycle 1: 5 mcg/m2/day IV days 1-7, then 15 mcg/m2/day IV days 8-28 of a 35 day cycle; Cycle 2: 15 mcg/m2/day IV days 1-28
Note: Dosing may vary per protocol. Supply may be study, compassionate, or commercial.
Cycle 1: 9 mcg daily as a continuous infusion on days 1 to 7, followed by 28 mcg daily as a continuous infusion on days 8 to 28 of a 6-week treatment cycle.
Cycles 2 through 5: 28 mcg daily as a continuous infusion on days 1 to 28 of a 6-week treatment cycle
Immediate (hours to days):
- Systemic cytokine release syndrome (chills, fever, fatigue, flushing, bronchospasm, hypotension), capillary leak syndrome, nausea, diarrhea, allergic reaction, rash
- CNS (headache, tremor, seizures, confusion, delirium, hallucinations, psychosis)
- Transient drop in platelets, neutrophils, hemoglobin, increase in transaminases, coagulopathies, hypokalemia; tumour lysis syndrome
- Treatment for unusual side effects is available through the study chair identified on the front page of the protocol and/or pharmacy.
Extravasation Hazard: None
- Pre-medicate with Dexamethasone 5 mg/m2 (maximum: 20 mg/dose), within 30-60 minutes prior to the first dose of blinatumomab in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.
- Premedication with dexamethasone for additional cycles or for interruptions lasting longer than four (4) hours in additional cycles, may be used according to the discretion of the treating physician.
- Daily nose-to-finger test and handwriting test can often predict future CNS toxicity before it develops.
- Document all infusion interruptions. If the cumulative interruption time over 28 days is greater than 24 hours, missed hours of blinatumomab may be added to the infusion time
- Infusion interruptions > 4 hours require re-admission to hospital to restart infusion
- Currently considered as having a low emetogenic potential
- No known drug interactions with Blinatumomab
- AMGEN Canada Inc., Product Monograph for BLINCYTO, June 29,2016