WHAT IS BLINCYTO® (blinatumomab)?

BLINCYTO® is a prescription medicine used to treat adults and children 1 month and older with:

  • B-cell precursor acute lymphoblastic leukemia (ALL) in remission when only a small number of cancer cells remain in the body (minimal residual disease)
  • B-cell precursor ALL that has come back or did not respond to previous treatments
  • Philadelphia chromosome-negative B-cell precursor ALL in the consolidation phase of chemotherapy treatment with multiple phases

ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control.
It is not known if BLINCYTO® is safe and effective in children less than 1 month of age.
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BLINCYTO® for Children

Give yourself a better chance against
B-cell precursor acute lymphoblastic
leukemia (BCP-ALL)

In a trial of adults with –negative [Ph(–)] after initial treatment ()

BLINCYTO® helped people who were 
MRD-negative live longer1,2

BLINCYTO® was studied in 224 adults aged 30–70 years with newly diagnosed Ph(–) . The goal of the study was to see whether people who were ) negative lived longer when BLINCYTO® was used with vs alone (112 people in each group), after initial treatment. This period of treatment is known as the phase.1,2

At 3 years, more people who received BLINCYTO® and

chemotherapy were alive vs chemotherapy alone1,*
chart showing 85% of people treated with BLINCYTO® plus chemotherapy were alive at 3 years compared to 69% with chemotherapy alone chart showing 85% of people treated with BLINCYTO® plus chemotherapy were alive at 3 years compared to 69% with chemotherapy alone

*This analysis looked at survival for a median follow-up of 3.6 years, and the proportion of people alive at 3 years was estimated.1

In this study, most people (57%) were given 4 cycles of BLINCYTO®.


Your doctor will decide how long you will stay on treatment.3,4

The use of BLINCYTO® after initial treatment () in children one month and older with Ph(–) is supported by data from the study above and 2 additional studies:1

  • Study of BLINCYTO® in in children aged 28 days to 18 years with Ph(–) in first 1
  • Study of BLINCYTO® in in young people aged 1–27 years with Ph(–) in first 5

I’m a real BLINCYTO®
patient. And this is my
story.

- Ryan

View Ryan’s story

Adding BLINCYTO® after initial treatment
helped children live cancer-free longer when
used with chemotherapy6

In a study that included 1,440 children aged 1 to less than 10 years, 718 were given both BLINCYTO® and in the phase of . The rest were given only .6

At 3 years, treatment with BLINCYTO® and chemotherapy helped
children live cancer-free longer vs chemotherapy alone6,*
chart showing 96% of children treated with BLINCYTO® plus chemotherapy were alive and cancer free at 3 years compared to 88% with chemotherapy alone chart showing 96% of children treated with BLINCYTO® plus chemotherapy were alive and cancer free at 3 years compared to 88% with chemotherapy alone

*Children were followed for an average of 2.5 years in this study.6

Said in another way, in the same study, children taking BLINCYTO®
with chemotherapy had fewer relapses than those who received
chemotherapy alone6,*

Relapse is when a disease or the signs and symptoms of a disease return2

At 3 years, 3% of children taking
BLINCYTO® and chemotherapy relapsed6

And 12% of children taking
chemotherapy alone relapsed6

  • This study included 32 children who had Down Syndrome (16 received BLINCYTO® + chemotherapy, and 16 received chemotherapy only)6
    • People with Down Syndrome may have a higher risk of seizure with BLINCYTO® treatment and may be given anti-seizure medicine before starting on BLINCYTO®1

*Children were followed for an average of 2.5 years in this study.6

BLINCYTO® may help children* whose
leukemia has returned (relapsed) or did not
respond to treatment (refractory)

In a separate study, young people ranging in age from 7 months to 17 years with or were treated with BLINCYTO®.1

Some people had more than one before the study. Others may have had a following a stem cell transplantation prior to getting BLINCYTO®, or for some their cancer may have been to other treatments.1

In a study of 70 children with BCP-ALL,1

had a complete response with BLINCYTO®1

means there were no signs of cancer after treatment, and blood tests for certain kinds of cells fully recovered to normal or partially recovered to normal within the first 2 treatment cycles.1,7

*Older than one month of age.1

Ask your doctor if BLINCYTO® is right for treating

your acute lymphoblastic leukemia (ALL)

See side effects
SUMMARY SUMMARY

Discover how BLINCYTO® (blinatumomab) helped children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) live cancer‑free longer, and how children whose cancer returned responded to treatment.
For people who are MRD-negative For children after initial treatment For children with relapsed or 
refractory disease

Important Safety Information

What is the most important information I should know about BLINCYTO®?

  • Call your health care provider or get emergency medical help right away if you get any of the symptoms listed below:
    • BLINCYTO® may cause serious side effects that can be severe, life-threatening, or lead to death, including:
      • Cytokine Release Syndrome (CRS) and infusion reactions. Symptoms of CRS and infusion reactions may include: fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash.
      • Neurologic problems. Symptoms of neurologic problems may include: seizures, difficulty in speaking or slurred speech, loss of consciousness, trouble sleeping, confusion and disorientation, loss of balance, headache, difficulty with facial movements, hearing, vision, or swallowing, and tremors. People with Down Syndrome may have a higher risk of seizures with BLINCYTO® treatment and may be given anti‑seizure medicine before starting BLINCYTO® treatment.
    • Your health care provider will check for these problems during treatment with BLINCYTO®. Your health care provider may temporarily or completely stop your treatment with BLINCYTO® if you have severe side effects.

Who should not receive BLINCYTO®?

  • Do not receive BLINCYTO® if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO®.

Before receiving BLINCYTO®, tell your health care provider about all of your medical conditions, including if you or your child:

  • have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance
  • have Down Syndrome
  • have an infection
  • have ever had an infusion reaction after receiving BLINCYTO® or other medications
  • have a history of radiation treatment to the brain, or chemotherapy treatment
  • are scheduled to receive a vaccine. You should not receive a “live vaccine” within 2 weeks before you start treatment with BLINCYTO®, during treatment, and until your immune system recovers after you receive your last cycle of BLINCYTO®. If you are not sure about the type of vaccine, ask your health care provider.
  • are pregnant or plan to become pregnant. BLINCYTO® may harm your unborn baby. Tell your health care provider if you become pregnant during treatment with BLINCYTO®.
    • If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with BLINCYTO®.
    • Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with BLINCYTO®, and for 48 hours after your last dose of BLINCYTO®.
  • are breastfeeding or plan to breastfeed. It is not known if BLINCYTO® passes into your breast milk. You should not breastfeed during treatment with BLINCYTO® and for 48 hours after your last dose.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving BLINCYTO®?

  • Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving BLINCYTO® because BLINCYTO® can cause neurological symptoms such as dizziness, seizures, and confusion.

BLINCYTO® may cause serious side effects, including:

  • Infections. BLINCYTO® may cause life-threatening infections that may lead to death. Tell your health care provider right away in case you develop any signs or symptoms of an infection.
  • Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can be life-threatening and may lead to death. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with BLINCYTO®, including: nausea and vomiting, confusion, shortness of breath, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness, muscle cramps.
  • Low white blood cell counts (neutropenia). Neutropenia is common with BLINCYTO® treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your health care provider will do blood tests to check your white blood cell counts during treatment with BLINCYTO®. Tell your health care provider right away if you get a fever.
  • Abnormal liver blood test. Your health care provider will do blood tests to check your liver before you start BLINCYTO® and during treatment with BLINCYTO®.
  • Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in patients treated with BLINCYTO® and corticosteroids. It may be severe and lead to death. Tell your health care 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.
  • Your health care provider will do blood tests during treatment to check for side effects.

The most common side effects

  • The most common side effects of BLINCYTO® include:
  • Fever
  • Reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
  • Headache
  • Infection
  • Muscle, joint, and bone pain
  • Low white blood cell count (neutropenia)
  • Nausea
  • Low red blood cell count (anemia)
  • Low platelet count (thrombocytopenia)
  • Diarrhea

These are not all the possible side effects of BLINCYTO®.

Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read the accompanying Medication Guide before you or your child receives BLINCYTO® and before each BLINCYTO® infusion and discuss it with your doctor.

Please see BLINCYTO® full Prescribing Information, including BOXED WARNINGS and Medication Guide.
References:

  • 1. BLINCYTO® (blinatumomab) prescribing information, Amgen.

  • 2. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-negative acute lymphoblastic leukemia in adults. N Engl J Med. 2024;391:320-333.

  • 3. Data on file, Amgen; 2024.

  • 4. BLINCYTO® (blinatumomab) medication guide, Amgen.

  • 5. Brown PA, Ji L, Xu X, et al. Effect of postreinduction therapy consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. 2021;325(suppl 2):833-842.

  • 6. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. 2025;392:875-891.

  • 7. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 17, 2026.