Blinatumomab – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 46 min read
Blinatumomab - Uses, Dosage, Side Effects, Interaction
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Article Summary

Blinatumomab is an antineoplastic antibody used to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab is a BiTE-class (bi-specific T-cell engagers) constructed monoclonal antibody indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto™. A full treatment regimen consisting of two cycles...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindication in simple medical language.
  • This article explains Dosage in simple medical language.
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Definition

Blinatumomab is an antineoplastic antibody used to treat Philadelphia chromosome-negative relapsed or B-cell precursor lymphoblastic (ALL). Blinatumomab is a BiTE-class (bi-specific T-cell engagers) constructed monoclonal antibody indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab is manufactured by Amgen Inc. and marketed under the brand Blincyto™. A full treatment regimen consisting of two cycles of four weeks each is priced at $178 000 USD. Blinatumomab was approved in December 2014 under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.

Blinatumomab (Blincyto, Amgen), a bi-specific antibody, is a first-in-class, targeted agent for the treatment of B-cell malignancies with a novel mechanism of action which involves in-vivo engagement of the patient’s T cells with CD19-expressing cells. Clinical trials have demonstrated its efficacy in relapsed B-cell Acute Lymphoblastic (B-ALL) and B-cell Non-Hodgkin’s including in patients who are refractory to . This review summarises the development and design of Blinatumomab, the outcome of clinical studies demonstrating its efficacy, and how to manage the administration, practically, including relevant toxicities. We compare and contrast it to other emerging agents for the treatment of B-cell malignancies.

Blinatumomab is a 55-kilodalton fusion protein consisting of two recombinantly expressed single-chain variable fragments (murine anti-CD19 and anti-CD3) joined by a flexible glycine-serine linker.  CD19 is a cell surface antigen expressed ubiquitously on precursor B-cells and has been implicated in the self-renewal capacity of leukemia cells

Mechanism of action

Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It activates endogenous T cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on and B cells. Blinatumomab mediates the formation of a synapse between the T cell and the tumor cell, upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells, which result in redirected lysis of CD19+ cells.

Indications

  • Indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
  • B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
  • Refractory B-cell precursor acute lymphoblastic leukemia
  • Relapsed B cell precursor Acute lymphoblastic leukemia
  • MRD-positive B-cell Precursor ALL: For B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete 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)

Use in Cancer

Blinatumomab is approved to treat:

  • B-cell acute lymphoblastic leukemia in adults and children. It is used:
    • In patients whose cancer has recurred (come back) or is refractory (does not respond to treatment).
    • In some patients whose cancer is in complete remission. This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that blinatumomab provides a clinical benefit in these patients.

Blinatumomab is also being studied in the treatment of other types of cancer.

  • a bad
  • low levels of a type of white blood cell called neutrophils
  • leukoencephalopathy is a disease of the white matter of the brain
  • seizures
  • pregnancy

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 (a total of 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)
  • 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, premedication with prednisone 100 mg IV or equivalent (e.g., dexamethasone 16 mg) 1 hour before 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 (a total of 42 days).
  • A single cycle of continued therapy consists of 28 days of continuous IV infusion followed by a 56-day treatment-free interval (a total of 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)
  • 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, premedication with 20 mg dexamethasone 1 hour before the first dose in each cycle, before a step dose (such as Cycle 1 Day 8), and when restarting an infusion after an interruption of 4 or more hours.

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 (a total of 42 days).

1 MONTH AND OLDER/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)

1 MONTH AND OLDER/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)
  • 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, premedication with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg before 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 (a total of 42 days).
  • A single cycle of continued therapy consists of 28 days of continuous IV infusion followed by a 56-day treatment-free interval (a total of 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)
  • 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, premedication with 5 mg/m2 of dexamethasone, to a maximum dose of 20 mg before the first dose of this drug in the first cycle, before 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)

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 (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:

  • : 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.

Side Effects

The Most Common

  • weight gain
  • back, joint, or
  • of the arms, hands, feet, ankles, or lower legs
  • at the injection site
  • or in the arms, legs, hands, or feet
  • ongoing pain that begins in the stomach area but may spread to the back that may occur with or without and vomiting
  • fever, sore throat, cough, and other signs of infection

More Common

  • fever
  • headache
  • swelling of the extremities
  • nausea
  • tremor
  • rash
  • constipation
  • fever accompanying low levels of white blood cells (febrile neutropenia), and
  • low levels of potassium in the blood (hypokalemia)
  • anemia
  • low platelet levels in the blood
  • low white blood cell count
  • irregular heartbeats (arrhythmia)
  • diarrhea
  • abdominal pain
  • vomiting
  • fatigue
  • chills
  • chest pain
  • infections
  • weight gain
  • decreased appetite
  • back pain
  • pain in extremities
  • bone pain
  • joint pain
  • dizziness
  • insomnia
  • cough
  • shortness of breath
  • nosebleeds
  • high or low blood pressure (hypertension or hypotension)

Rare

  • Infections. blinatumomab may cause life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.
  • Low white blood cell counts (neutropenia). Neutropenia is common with blinatumomab treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell count during treatment with this medicine. Tell your healthcare provider right away if you get a fever.
  • Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start this medicine and during treatment.
  • Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with blinatumomab and corticosteroids. It may be severe and lead to death. Tell your healthcare provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.
  • infections
  • low platelet count (thrombocytopenia)
  • fever
  • reactions related to the infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
  • headache
  • low red blood cell count (anemia)

Drug Interaction

Pregnancy and Lactation

US FDA pregnancy category: Not assigned

Pregnancy

If you are pregnant or are planning to become pregnant, blinatumomab may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with blinatumomab.

  • If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with blinatumomab.
  • Females who are able to become pregnant should use an effective form of birth control during treatment with blinatumomab, and for 48 hours after the last dose of blinatumomab.

Lactation

If you are breastfeeding or plan to breastfeed, it is not known if blinatumomab passes into your breast milk.

  • You should not breastfeed during treatment with blinatumomab and for 48 hours after your last treatment.

How should this medicine be used?

Blinatumomab comes as a powder to be mixed with liquid to be slowly injected intravenously (into a vein) by a doctor or nurse in a hospital or medical facility and sometimes at home. This medication is given continuously for 4 weeks followed by 2 to 8 weeks when the medication is not given. This treatment period is called a cycle, and the cycle may be repeated as necessary. The length of treatment depends on how you respond to the medication.

Your doctor may need to delay your treatment, change your dose, or stop your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with blinatumomab injection.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving blinatumomab injection,

  • tell your doctor and pharmacist if you are allergic to blinatumomab, any other medications, benzyl alcohol. or any other ingredients in blinatumomab injection. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine (Gengraf, Neoral, Sandimmune) or warfarin (Coumadin, Jantoven). Many other medications may also interact with blinatumomab, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have an infection or if you have or have ever had an infection that keeps coming back. Also, tell your doctor if you have ever had radiation therapy to the brain or have received chemotherapy or have or have ever had liver disease.
  • tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you receive this medication. You should not become pregnant during your treatment with blinatumomab and for at least 2 days after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using blinatumomab, call your doctor. Blinatumomab may harm the fetus.
  • tell your doctor if you are breastfeeding. Do not breastfeed while receiving blinatumomab and for at least 2 days after your final dose.
  • you should know that blinatumomab injection may make you drowsy. Do not drive a car or operate machinery while you are receiving this medication.
  • do not have any vaccinations without talking to your doctor. Tell your doctor if you have received a vaccine within the past 2 weeks. After your final dose, your doctor will tell you when it is safe to receive a vaccine.

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Which doctor may help?

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What to tell the doctor

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Safe first steps

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  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

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Get urgent help if

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  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Is physiotherapy, posture correction, or activity modification needed?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Blinatumomab – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

Internal learning pathway

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