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).

• 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)

• 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)

• 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.

• 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).

• 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)

• 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)

• 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.

• 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).

• 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)

• 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)

• 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.

• 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).

• 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)

• 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)

• 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.

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

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Hypersensitivity to the active component or any of the ingredients

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.

• 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.

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

• Refer to the manufacturer product information.

• 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.

• 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.

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