Blinatumomab Dosage

Medically reviewed by Drugs.com. Last updated on May 5, 2025.

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.

Frequently asked questions

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See also:

Further information

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