Blincyto for treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia

Blincyto (blinatumomab) is an intravenous injection used to treat certain types of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). It is approved for both adult and pediatric patients aged one month and older, helping to treat ALL in remission with minimal residual disease or in relapsed/refractory cases, including during consolidation chemotherapy.

• Treatment of CD19-positive B-cell precursor ALL in patients one month and older who are in first or second complete remission but have minimal residual disease (≥0.1%).
• Treatment of relapsed or refractory CD19-positive B-cell precursor ALL in patients one month and older.
• Treatment during the consolidation phase of multiphase chemotherapy for CD19-positive Philadelphia chromosome-negative B-cell precursor ALL in patients one month and older.

blinatumomab

Blincyto is a bispecific T-cell engager that connects CD3-positive T cells to CD19-positive B-cell precursor leukemia cells. This connection activates the patient's T cells to attack and kill the leukemia cells, aiding in controlling the disease.

Treatment courses and cycles

Treatment involves continuous intravenous infusion using an infusion pump, with dosing adjusted by patient weight or body surface area (BSA). Patients weighing 45 kg or more receive fixed doses; lighter patients have doses calculated by BSA.

MRD-positive B-cell precursor ALL

• Induction: 28 mcg/day for 28 days followed by 14 days off.
• Consolidation: Up to 3 additional cycles, same dose and schedule.
• Hospitalization recommended for first 3 days of cycle 1 and first 2 days of cycle 2.
• Premedication with prednisone 100 mg IV or equivalent (e.g., dexamethasone 16 mg) one hour before first dose in each cycle for adults; pediatric patients receive dexamethasone 5 mg/m² (max 20 mg) prior to first dose and after interruptions.

Relapsed or refractory B-cell precursor ALL

• Induction Cycle 1: 9 mcg/day days 1-7, then escalate to 28 mcg/day days 8-28; followed by 14 days off.
• Additional cycles include induction, consolidation, and continued therapy (up to 9 cycles), with dose and intervals adjusted accordingly.
• Hospitalization recommended first 9 days of first cycle and first 2 days of second cycle.
• Premedicate with dexamethasone 20 mg IV/oral one hour before first dose, before dose escalations, and after interruptions. Pediatric dosing uses dexamethasone 5 mg/m² (max 20 mg).

Consolidation phase of B-cell precursor ALL

• 28 mcg/day for 28 days followed by 14 days off, up to 3 cycles.
• Hospitalization recommended for the first 3 days of first cycle and first 2 days of second cycle.
• Premedication with dexamethasone 20 mg IV (or 5 mg/m² in pediatric patients) before first dose and after interruptions.

Administration details

• Administer as a continuous IV infusion over 24, 48, 72, 96 hours, or 7 days, per healthcare provider discretion.
• Longer infusions (≥72 hours) use preservative-containing saline and are not recommended for patients weighing less than 5.4 kg.
• If infusion is interrupted less than 7 days, continue the same cycle to complete 28 days; longer interruptions require starting a new cycle.

Serious risks

• Cytokine release syndrome (CRS): May be life-threatening or fatal. Requires interruption or permanent discontinuation of Blincyto and corticosteroid treatment.
• Neurological toxicities: Includes immune effector cell-associated neurotoxicity syndrome (ICANS), which can be severe, life-threatening, or fatal. Requires interruption or discontinuation and corticosteroid management.

Common and serious side effects

• Cytokine release syndrome symptoms such as fever, chills, hypotension, and respiratory difficulties.
• Neurological events including seizures, confusion, tremor, and encephalopathy.
• Other severe neurologic events may require permanent discontinuation.

The label does not provide specific drug interaction details.

Storage times for Blincyto preparation

• Reconstituted vial: 4 hours at room temperature (23°C to 27°C), 24 hours refrigerated (2°C to 8°C).
• Prepared infusion bags (preservative-free 24 or 48-hour): Use within 48 hours including infusion time; do not refrigerate again if unused.
• Prepared infusion bags with preservative (72, 96 hours, or 7-day): Stored up to 4 days at room temperature, 14 days refrigerated.