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Blinatumomab Dosage

Medically reviewed on May 29, 2018.

Applies to the following strengths: 35 mcg

Usual Adult Dose for Acute Lymphoblastic Leukemia

MRD-POSITIVE B-CELL PRECURSOR ALL:
-A therapy course consists of 1 cycle of this drug for induction followed by up to 3 additional cycles for consolidation.
-A single cycle of therapy of induction or consolidation consists of 28 days of continuous IV infusion followed by a 14-day treatment-free interval (total 42 days).
LESS THAN 45 KG:
-Induction Cycle 1: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 2 through 4: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
45 KG OR GREATER:
-Induction Cycle 1: 28 mcg IV daily on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 2 through 4: 28 mcg/day on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
COMMENTS:
-Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and reinitiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
-For adult patients, premedicate with prednisone 100 mg IV or equivalent (e.g., dexamethasone 16 mg) 1 hour prior to the first dose in each cycle.

RELAPSED OR REFRACTORY B-CELL PRECURSOR ALL:
-A therapy course consists of up to 2 cycles for induction followed by up to 3 additional cycles for consolidation and up to 4 cycles of continued therapy.
-A single cycle of therapy of induction or consolidation consists of 28 days of continuous IV infusion followed by a 14-day treatment-free interval (total 42 days).
-A single cycle of continued therapy consists of 28 days of continuous IV infusion followed by a 56-day treatment-free interval (total 84 days).
LESS THAN 45 KG:
-Induction Cycle 1: 5 mcg/m2 IV daily (not to exceed 9 mcg/day) on Days 1 through 7 followed by 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 8 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Induction Cycle 2: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 3 Through 5: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Continued Therapy Cycles 6 Through 9: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 56-day treatment-free interval (Days 29 through 84)
45 KG OR GREATER:
-Induction Cycle 1: 9 mcg IV daily on Days 1 through 7 followed by a 28 mcg IV daily on Days 8 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Induction Cycle 2: 28 mcg IV daily on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 3 Through 5: 28 mcg IV daily on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Continued Therapy Cycles 6 Through 9: 28 mcg IV daily on Days 1 through 28 followed by a 56-day treatment-free interval (Days 29 through 84)
COMMENTS:
-Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and reinitiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
-For adult patients, premedicate with 20 mg dexamethasone 1 hour prior to the first dose in each cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours.

Uses:
-MRD-positive B-cell Precursor ALL: For B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
-Relapsed or Refractory B-cell Precursor ALL: For relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

MRD-POSITIVE B-CELL PRECURSOR ALL:
-A therapy course consists of 1 cycle of this drug for induction followed by up to 3 additional cycles for consolidation.
-A single cycle of therapy of induction or consolidation consists of 28 days of continuous IV infusion followed by a 14-day treatment-free interval (total 42 days).
GREATER THAN 1 MONTH/LESS THAN 45 KG:
-Induction Cycle 1: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 2 through 4: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
GREATER THAN 1 MONTH/45 KG OR GREATER:
-Induction Cycle 1: 28 mcg IV daily on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 2 through 4: 28 mcg/day on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
COMMENTS:
-Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and reinitiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
-For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg prior to the first dose of this drug in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.

RELAPSED OR REFRACTORY B-CELL PRECURSOR ALL:
-A therapy course consists of up to 2 cycles for induction followed by up to 3 additional cycles for consolidation and up to 4 cycles of continued therapy.
-A single cycle of therapy of induction or consolidation consists of 28 days of continuous IV infusion followed by a 14-day treatment-free interval (total 42 days).
-A single cycle of continued therapy consists of 28 days of continuous IV infusion followed by a 56-day treatment-free interval (total 84 days).
LESS THAN 45 KG:
-Induction Cycle 1: 5 mcg/m2 IV daily (not to exceed 9 mcg/day) on Days 1 through 7 followed by 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 8 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Induction Cycle 2: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 3 Through 5: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Continued Therapy Cycles 6 Through 9: 15 mcg/m2 IV daily (not to exceed 28 mcg/day) on Days 1 through 28 followed by a 56-day treatment-free interval (Days 29 through 84)
45 KG OR GREATER:
-Induction Cycle 1: 9 mcg IV daily on Days 1 through 7 followed by a 28 mcg IV daily on Days 8 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Induction Cycle 2: 28 mcg IV daily on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Consolidation Cycles 3 Through 5: 28 mcg IV daily on Days 1 through 28 followed by a 14-day treatment-free interval (Days 29 through 42)
-Continued Therapy Cycles 6 Through 9: 28 mcg IV daily on Days 1 through 28 followed by a 56-day treatment-free interval (Days 29 through 84)
COMMENTS:
-Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and reinitiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
-For pediatric patients, premedicate with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg prior to the first dose of this drug in the first cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours in the first cycle.

Uses:
-MRD-positive B-cell Precursor ALL: For B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
-Relapsed or Refractory B-cell Precursor ALL: For relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Renal Dose Adjustments

CrCl 30 mL/min or more: No adjustment recommended.
CrCl less than 30 mL/min: Data not available

Liver Dose Adjustments

Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to the start of and during therapy. Interrupt therapy if the transaminases rise to greater than 5 times the upper limit of normal (ULN) or if total bilirubin rises to more than 3 x ULN.

Dose Adjustments

DOSE MODIFICATION GUIDELINES FOR ADVERSE EVENTS:
-If the interruption after an adverse event is no longer than 7 days, continue the same cycle to a total of 28 days of infusion inclusive of days before and after the interruption in that cycle.
-If an interruption due to an adverse event is longer than 7 days, start a new cycle.

Cytokine Release Syndrome (CRS) Toxicity:
LESS THAN 45 KG:
-Grade 3: Withhold therapy until resolved, and then restart at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur.
-Grade 4: Discontinue therapy permanently.
45 KG OR GREATER:
-Grade 3: Withhold therapy until resolved, and then restart at 9 mcg/day. Escalate to 28 mcg/ day after 7 days if the toxicity does not recur.
-Grade 4: Discontinue therapy permanently.

Neurological Toxicity:
LESS THAN 45 KG:
-Seizure: Discontinue therapy permanently if more than one seizure occurs.
-Grade 3: Withhold therapy until no more than Grade 1 and for at least 3 days, then restart therapy at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur. If the toxicity occurred at 5 mcg/m2/day, or if the toxicity takes more than 7 days to resolve, discontinue therapy permanently.
-Grade 4: Discontinue therapy permanently.
45 KG OR GREATER:
-Seizure: Discontinue therapy permanently if more than one seizure occurs.
-Grade 3: Withhold therapy until no more than Grade 1 and for at least 3 days, then restart therapy at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the toxicity does not recur. If the toxicity occurred at 9 mcg/day, or if the toxicity takes more than 7 days to resolve, discontinue therapy permanently.
-Grade 4: Discontinue therapy permanently.

Other Clinically Relevant Adverse Reactions:
LESS THAN 45 KG:
-Grade 3: Withhold therapy until no more than Grade 1, then restart therapy at 5 mcg/m2/day. Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur. If the toxicity takes more than 14 days to resolve, discontinue therapy permanently.
-Grade 4: Discontinue therapy permanently.
45 KG OR GREATER:
-Grade 3: Withhold therapy until no more than Grade 1, and then restart therapy at 9 mcg/day. Escalate to 28 mcg/day after 7 days if the toxicity does not recur. If the toxicity takes more than 14 days to resolve, discontinue therapy permanently. -Grade 4: Consider discontinuing therapy permanently.

Precautions

US BOXED WARNINGS:
-CYTOKINE RELEASE SYNDROME (CRS): Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving this drug. Interrupt or discontinue therapy as recommended.
-NEUROLOGICAL TOXICITIES: Neurological toxicities, which may be severe and life-threatening, or fatal, have occurred in patients receiving this drug. Interrupt or discontinue therapy as recommended.

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients

The safety and efficacy of this drug has not been established in patients less than 1 month of age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be administered as a continuous IV infusion at a constant flow rate using an infusion pump.
-Do not flush the infusion line especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications.
-This drug should be infused through a dedicated lumen.

Comments:
-The infusion line should not be flushed especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof.
-This drug should be administered as a continuous IV infusion at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non-elastomeric, and have an alarm.
-The infusion line should not be flushed especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof.
-The infusion bags should be infused over 24 or 48 hours.


General:
-Any unused solution in the IV bag and IV lines should be disposed of in accordance with local requirements.

Reconstitution/preparation/storage advice:
-Refer to the manufacturer product information.

Patient advice:
Contact a healthcare provider for any of the following:
-Symptoms that may be associated with cytokine release syndrome and infusion reactions including pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, and wheezing.
-Symptoms of neurological toxicities including convulsions, speech disorders, and confusion.
-Symptoms of infections including pneumonia.
If there is a problem with the pump or it alarms, patients should contact their healthcare provider.
Additional patient advice:
-Patients should be advised to refrain from driving and engaging in hazardous activities such as operating machinery while being treated.
-The area around the IV catheter should be kept clean to reduce the risk of infection.
-The patient should not adjust the setting on the infusion pump.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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