Blinatumomab Dosage

Medically reviewed by drugclasses.com. Last updated on May 6, 2024.

Applies to the following strengths: 35 mcg

Usual Adult Dose for Acute Lymphoblastic Leukemia

MINIMAL RESIDUAL DISEASE (MRD) CD19-POSTIVE B CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (ALL):
Weight 45 kg or more (Fixed-Dose):

Induction Cycle 1: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 2 to 4: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42

Weight less than 45 kg (body surface area (BSA)-based Dose):

Induction Cycle 1: Administer 15 mcg/m2 IV daily on Days 1 to 28 (maximum 28 mcg/day), followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 2 to 4: Administer 15 mcg/m2 IV daily on Days 1 to 28 (maximum 28 mcg/day), followed by 14-day treatment free interval on Days 29 to 42

RELAPSED OR REFRACTORY CD19-POSITIVE B CELL PRECURSOR ALL:
Weight 45 kg or more (Fixed-Dose):

Induction Cycle 1: Administer 9 mcg IV daily on Days 1 to 7, followed by 28 mcg IV daily on Days 8 to 28, followed by 14-day treatment free interval on Days 29 to 42
Induction Cycle 2: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 3 to 5: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Continued Therapy Cycles 6 to 9: Administer 28 mcg IV daily on Days 1 to 28, followed by 56-day treatment free interval on Days 29 to 84

Weight less than 45 kg (BSA-based Dose):

Induction Cycle 1: Administer 5 mcg/m2 IV daily (maximum 9 mcg/day) on Days 1 to 7, followed by 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 8 to 28, followed by 14-day treatment free interval on Days 29 to 42
Induction Cycle 2: Administer 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 3 to 5: Administer 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Continued Therapy Cycles 6 to 9: Administer 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 1 to 28, followed by 56-day treatment free interval on Days 29 to 84

Comments:

Administer as a continuous IV infusion over 24 hours or 48 hours (preservative-free product) or over 7 days (product with preservative). Choice of infusion duration should be made by the treating health care provider in consideration of patient weight and frequency of infusion bag changes.
Consult the manufacturer product information for full details regarding dosage and administration.
Hospitalization of the patient is recommended for the first and second cycles of therapy.
Subsequent cycle starts and re-initiations should be supervised by a health care professional OR hospitalization is recommended.
Premedication with corticosteroids is recommended 1 hour prior to first dose in each cycle, or as indicated.
Strictly follow manufacturer recommendations to avoid medication errors or overdose.

Uses:

For the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with a MRD of 0.1% or greater
For the treatment of relapsed or refractory CD19-positive B-cell precursor ALL

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

Age 1 month or older:
MRD CD19-POSITIVE B CELL PRECURSOR ALL:
Weight 45 kg or more (Fixed-Dose):

Induction Cycle 1: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 2 to 4: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42

Weight less than 45 kg (BSA-based Dose):

Induction Cycle 1: Administer 15 mcg/m2 IV daily on Days 1 to 28 (maximum 28 mcg/day), followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 2 to 4: Administer 15 mcg/m2 IV daily on Days 1 to 28 (maximum 28 mcg/day), followed by 14-day treatment free interval on Days 29 to 42

RELAPSED OR REFRACTORY CD19-POSITIVE B CELL PRECURSOR ALL:
Weight 45 kg or more (Fixed-Dose):

Induction Cycle 1: Administer 9 mcg IV daily on Days 1 to 7, followed by 28 mcg IV daily on Days 8 to 28, followed by 14-day treatment free interval on Days 29 to 42
Induction Cycle 2: Administer 28 mcg/m2 IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 3 to 5: Administer 28 mcg IV daily on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Continued Therapy Cycles 6 to 9: Administer 28 mcg IV daily on Days 1 to 28, followed by 56-day treatment free interval on Days 29 to 84

Weight less than 45 kg (BSA-based Dose):

Induction Cycle 1: Administer 5 mcg/m2 IV daily (maximum 9 mcg/day) on Days 1 to 7, followed by 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 8 to 28, followed by 14-day treatment free interval on Days 29 to 42
Induction Cycle 2: Administer 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Consolidation Cycles 3 to 5: Administer 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 1 to 28, followed by 14-day treatment free interval on Days 29 to 42
Continued Therapy Cycles 6 to 9: Administer 15 mcg/m2 IV daily (maximum 28 mcg/day) on Days 1 to 28, followed by 56-day treatment free interval on Days 29 to 84

Comments:

Administer as a continuous IV infusion over 24 hours or 48 hours (preservative-free product) or over 7 days (product with preservative). Choice of infusion duration should be made by the treating health care provider in consideration of patient weight and frequency of infusion bag changes.
Consult the manufacturer product information for full details regarding dosage and administration.
Use preservative-free formulations when possible in neonates to avoid benzyl alcohol toxicity.
Hospitalization of the patient is recommended for the first and second cycles of therapy.
Subsequent cycle starts and re-initiations should be supervised by a health care professional OR hospitalization is recommended.
Premedication with corticosteroids is recommended 1 hour prior to first dose in each cycle, or as indicated.
Strictly follow manufacturer recommendations to avoid medication errors or overdose.

Uses:

For the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with a MRD of 0.1% or greater
For the treatment of relapsed or refractory CD19-positive B-cell precursor ALL

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Liver dysfunction: Data not available

Dose Adjustments

DOSE MODIFICATION GUIDELINES FOR ADVERSE EVENTS:

If treatment interruption after an adverse reaction is 7 days or less, 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 reaction is longer than 7 days, start a new cycle.

CYTOKINE RELEASE SYNDROME (CRS):
Grade 3:

Weight 45 kg or more: Interrupt therapy. Administer dexamethasone 8 mg IV or orally every 8 hours for up to 3 days, then taper over 4 days. After CRS resolution, restart therapy at 9 mcg IV daily; escalate to 28 mcg IV daily after 7 days if no reoccurrence.
Weight less than 45 kg: Interrupt therapy. Administer dexamethasone 5 mg/m2 (maximum 8 mg) IV or orally every 8 hours for up to 3 days, then taper over 4 days. After CRS resolution, restart therapy at 5 mcg/m2 IV daily; escalate to 15 mcg/m2 IV daily after 7 days if no reoccurrence.

Grade 4: Discontinue treatment permanently. Administer dexamethasone as instructed for Grade 3 CRS.

NEUROLOGICAL TOXICITY:
Grade 3:

Weight 45 kg or more: Withhold therapy until grade 1 or less and for at least 3 days, then restart at 9 mcg IV daily; escalate to 28 mcg IV daily after 7 days if no reoccurrence.
Permanently discontinue therapy if reaction occurred at 9 mcg IV daily or takes more than 7 days to resolve.
Weight less than 45 kg: Withhold therapy until grade 1 or less and for at least 3 days, then restart at 5 mcg/m2 IV daily; escalate to 15 mcg/m2 IV daily after 7 days if no reoccurrence.
Permanently discontinue therapy if reaction occurred at 5 mcg/m2 IV daily or takes more than 7 days to resolve.

Grade 4: Discontinue treatment permanently.

SEIZURES: Discontinue treatment permanently if more than 1 seizure occurs.

OTHER CLINICALLY RELEVANT ADVERSE REACTIONS:
Grade 3:

Weight 45 kg or more: Withhold therapy until grade 1 or less, then restart at 9 mcg IV daily; escalate to 28 mcg IV daily after 7 days if no reoccurrence.
Permanently discontinue therapy if reaction takes more than 14 days to resolve.
Weight less than 45 kg: Withhold therapy until grade 1 or less, then restart at 5 mcg/m2 IV daily; escalate to 15 mcg/m2 IV daily after 7 days if no reoccurrence.
Permanently discontinue therapy if reaction takes more than 14 days to resolve.

Grade 4: Consider discontinuing treatment permanently.

Precautions

US BOXED WARNINGS:

CYTOKINE RELEASE SYNDROME (CRS): Life-threatening or fatal CRS occurred in patients who received this drug. In the event of CRS, interrupt or discontinue therapy and treat with corticosteroids as recommended.
NEUROLOGICAL TOXICITIES: Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred in patients treated with this drug; events may be severe, life-threatening, or fatal. Interrupt or discontinue the drug for neurologic toxicity as recommended.

CONTRAINDICATIONS:

Known hypersensitivity to the active component or to any of the ingredients

Safety and efficacy have not been established in patients younger than 1 month.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

For IV use only
IMPORTANT: Consult the manufacturer product information and strictly follow recommendations for preparation and administration.
Administer as a continuous IV infusion at a constant flow rate using an infusion pump.
Infuse through a dedicated lumen with IV tubing that contains a low protein-binding 0.2 micron in-line filter.
For 24 hour infusion: Infuse at a rate of 10 mL/hr
For 48 hour infusion: Infuse at a rate of 5 mL/hr
For 7 day infusion: Infuse at a rate of 0.6 mL/hour; do NOT use an in-line filter
Do NOT flush the infusion line or IV catheter, especially when changing infusion bags.

MRD CD19-POSITIVE B CELL PRECURSOR ALL:
Hospitalization Recommendations:

For the first 3 days of the first cycle and the first 2 days of the second cycle.
For all subsequent cycle starts and re-initiations (e.g., treatment interruption of 4 or more hours), medical supervision OR hospitalization is recommended.

Premedication:

Adults: Prednisone 100 mg or equivalent (e.g., dexamethasone 16 mg) IV 1 hour prior to first dose in each cycle.
Pediatric: Dexamethasone 5 mg/m2 (maximum dose: 20 mg) prior to first dose in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle.

RELAPSED OR REFRACTORY CD19-POSITIVE B CELL PRECURSOR ALL:
Hospitalization Recommendations:

For the first 9 days of the first cycle and the first 2 days of the second cycle.
For all subsequent cycle starts and re-initiations, medical supervision OR hospitalization is recommended.

Premedication:

Adults: Dexamethasone 20 mg administered 1 hour prior to the first dose of each cycle, prior to a step dose (such as Cycle 1 Day 8), and when restarting the infusion after an interruption of 4 or more hours.
Pediatric: Dexamethasone 5 mg/m2 (maximum dose 20 mg) prior to the first dose of the first cycle, prior to a step dose, and when restarting an infusion after an interruption of 4 or more hours in the first cycle.

Storage requirements:

Vials and IV solution stabilizer: Store refrigerated (2C to 8C [36F to 46F]) until time of use OR for a maximum of 8 hours at room temperature (23C to 27C [73F to 81F]) in original package to protect from light; do not freeze
Reconstituted vial: 4 hours at room temperature; 24 hours refrigerated
Prepared infusion bag (preservative free): 48 hours at room temperature; 8 days refrigerated
Prepared infusion bag (WITH preservative): 7 days at room temperature; 14 days refrigerated
For infusion bags, storage time includes infusion time; if not administered within indicated time frames and temperatures, discard and do not refrigerate again.

Reconstitution/preparation techniques:

Refer to the manufacturer product information and strictly follow preparation instructions.
Tables with specific volumes for admixture are available and should be consulted.
Ensure aseptic technique during infusion preparation; vials do not contain antimicrobial preservatives.
Do NOT reconstitute vials with IV solution stabilizer.
Do NOT prime IV tubing with 0.9% sodium chloride; only use the final prepared infusion solution (the infusion bag is prepared with overfill).
The final product for 7 day infusion contains preservative (i.e., bacteriostatic 0.9% Sodium Chloride containing 0.9% benzyl alcohol); the 24 hour and 48 hour infusions are prepared preservative free.
Call 1-800-77-AMGEN (1-800-772-6436) with questions about drug reconstitution and preparation.

IV compatibility:

Incompatible with di-ethylhexylphthalate (DEHP) due to the possibility of particle formation.
Use polyolefin, DEHP-free PVC, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes and IV tubing sets.

General:

This drug is intended for use under the guidance of a health care provider.
MRD CD19-Positive B Cell Precursor ALL: A treatment course consists of 1 cycle for induction, followed by up to 3 additional cycles for consolidation; cycles are 28 days of continuous IV therapy followed by 14 day treatment free interval (total 42 days).
Relapsed or Refractory CD19-Positive B Cell Precursor ALL: A treatment course consists of up to 2 cycles for induction, followed by up to 3 cycles for consolidation, and then up to 4 cycles of continued therapy; cycles are 28 days of continuous IV therapy followed by 14 day treatment free interval (for induction and consolidation, total 42 days) or a 56 day treatment free interval (for continued therapy, total 84 days).
Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to initiating treatment, during therapy, and until immune recovery following last treatment cycle.

Monitoring:

Hematologic: Neutropenia and associated laboratory parameters (during therapy)
Hepatic: AST, ALT, GGT, and total bilirubin (prior to and during therapy)
Immunologic: For signs/symptoms of cytokine release syndrome (during therapy)
Infections/infestations: For signs/symptoms of infection (during therapy)
Metabolic: For signs/symptoms of tumor lysis syndrome (during therapy); for new or worsening metabolic acidosis in pediatric patients receiving this drug with preservative (during therapy)
Neurologic: For signs/symptoms of neurological/CNS toxicities (during therapy)
Pediatric: B lymphocyte counts in infants exposed to this drug in-utero (before live virus vaccination)

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide).
Contact your health care provider and seek medical attention for signs/symptoms of:
Cytokine release syndrome
Infusion reactions
Neurological toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS)
Infections
Pancreatitis
Refrain from driving and engaging in hazardous occupations or activities.
Do not adjust setting on infusion pump during administration of this drug; dosing errors may occur.
Females of childbearing potential: Use effective contraception during treatment and for 48 hours after the last dose; inform your health care provider if you are pregnant before or become pregnant during therapy.
Understand that breastfeeding is not recommended during treatment.