• If an interruption due to an adverse reaction is <7 days, continue same cycle to a total of 28 days inclusive of days before and after interruption. If interruption >7 days, start a new cycle.

• Intrathecal chemotherapy prophylaxis is needed before and during therapy to prevent CNS ALL relapse.
• MRD-positive B-cell Precursor ALL: Premedicate adults 1 hr prior to 1st dose, in each cycle, with prednisone 100 mg IV or dexamethasone 16 mg IV. Premedicate pediatric patients prior to 1st dose in 1st cycle and when restarting infusion after an interruption of ≥4 hr in 1st cycle with 5 mg/m₂of dexamethasone IV or PO (max dose = 20 mg). Patient must be hospitalized for 1st 3 days of 1st cycle and 1st 2 days of 2nd cycle. If treatment is interrupted for ≥4 hr, supervision by a health care professional or hospitalization is needed.
• Relapsed or Refractory B-cell Precursor ALLPremedicate adults with 20 mg of dexamethasone IV or PO 1 hr before 1st dose of each cycle and before step dose (e.g., Cycle 1 Day 8), and when restarting infusion after interruption of ≥4 hr. Premedicate pediatric patients with 5 mg/m₂of dexamethasone IV or PO (max dose = 20 mg) before 1st dose in 1st cycle, before a step dose, and when restarting infusion after an interruption of ≥4 hr in 1st cycle. Patient must be hospitalized for 1st 9 days of 1st cycle and 1st 2 days of 2nd cycle. If treatment is interrupted for ≥4 hr, supervision by a health care professional or hospitalization is needed
• B-cell Precursor ALL in the Consolidation PhasePremedicate adults with dexamethasone 20 mg IV 1 hr before 1st dose of each cycle. Premedicate pediatric patients with 5 mg/m₂of dexamethasone IV or PO (max dose = 20 mg) before 1st dose in 1st cycle and when restarting infusion after interruption of ≥4 hr in 1st cycle. Patient must be hospitalized for 1st 3 days of 1st cycle and 1st 2 days of 2nd cycle. If treatment is interrupted for ≥4 hr, supervision by a health care professional or hospitalization is needed.

IV Administration:

• Wear gloves, gown, and mask while handling medication. Discard IV equipment in specially designated containers.

• Do not flush line, especially when changing bags or at completion of infusion; may result in excess or overdose. To prime IV tubing, use only the solution in the bag containing the FINAL prepared blinatumomab solution. Do not prime with 0.9% NaCl. Aseptically add 270 mL of 0.9% NaCl to polyolefin, DEHP-free PVC, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes. Use polyolefin, DEHP-free PVC, or EVA intravenous tubing sets.

  • Add 5.5 mL IV solution stabilizer to IV bag. Stabilizer is used to coat prefilled IV bag; do not use for reconstitution. Gently mix; avoid foaming. Discard remaining stabilizer.
  • Entire volume of admixed blinatumomab will be more than 240 mL volume administered to patient to account for priming and ensure patient received full dose. Remove air from infusion bag. Add or remove 0.9% NaCl from bag if needed to adjust volume to 265 to 275 mL.
  • Reconstitution: Reconstitute blinatumomab using 3 mL preservative-free sterile water for injection/vial. 12.5 mg/mL. Direct solution toward side of vial; gently swirl to avoid foaming. Do not shake. Solution is clear to opalescent, colorless to slightly yellow; do not infuse solutions that are cloudy, discolored, or contain a precipitate. Vials are stable at room temperature for 4 hr or 24 hr if refrigerated. Patients weighing ≥45 kg:For 9 mcg/day infused over 24 hr at a rate of 10 mL/hr, transfer 0.83 mL of reconstituted solution into IV bag. For 9 mcg/day infused over 48 hr at a rate of 5 mL/hr, transfer 1.7 mL of reconstituted solution into IV bag. For 28 mcg/day infused over 24 hr at a rate of 10 mL/hr, transfer 2.6 mL of reconstituted solution into IV bag. For 28 mcg/day infused over 48 hr at a rate of 5 mL/hr,transfer 5.2 mL of reconstituted solution (2.7 mL from one vial and 2.5 mL from a second vial) into IV bag. Patients weighing <45 kg:See package insert for volumes to add to IV bag for 5 mcg/m²/day and 15 mcg/m²/day dose. Diluted solution is stable for 48 hr at room temperature or for 8 days if refrigerated. May also be infused over 24 or 48 hr.
  • For 7-day infusion:Transfer 90 mL bacteriostatic 0.9% NaCl into empty IV bag. Transfer 2.2 mL IV solution stabilizer into IV bag containing saline solution. For patients weighing ≥45 kg: transfer 16.8 mL reconstituted blinatumomab into IV bag. Mix gently to avoid foaming. Add 1 mL 0.9% NaCl for final volume of 110 mL. Mix gently to avoid foaming. Remove air from IV bag; prime tubing with prepared solution, not with 0.9% NaCl. For patients weighing 22–<45 kg: See package insert for volumes to add to IV bag for 15 mcg/m²/day dose. Not recommended for patients weighing <22 kg.
• Rate: Infuse via programmable, lockable, nonelastomeric infusion pump with an alarm. Infuse 240 mL over 24 or 48 hr based on pharmacy label, at a rate of 10 mL/hr for 24 hr or 5 mL/hr for 48 hr. Use tubing that is sterile, nonpyrogenic, and low protein-binding, with a 0.2 micron in-line filter. Ensure tubing is compatible with infusion pump. If using a multilumen catheter, infuse blinatumomab through a dedicated lumen.
  • For 7-day infusion:Do not use an in-line filter for a 7-day bag. Infuse final infusion solution according to instructions on pharmacy label on the prepared bag at an infusion rate of 0.6 mL/hr for 7 days.