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 residua …read more

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 …read more

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Important Safety Information Prescribing Information Medication Guide Indications Health Care Professionals Contact Us

BLINCYTO® for Children

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

In a trial of adults with Philadelphia chromosomeAn abnormal fusion of 2 genes that can cause immature white blood cells to grow uncontrollably and build up in the bone marrow and blood. If the Philadelphia chromosome is present, then the cancer is known as Ph(+). If it is not present, it is known as Ph(–).–negative [Ph(–)] BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. after initial treatment (consolidationA phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body.)

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

BLINCYTO® was studied in 224 adults aged 30–70 years with newly diagnosed Ph(–) BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood.. The goal of the study was to see whether people who were minimal residual disease (MRD)"MRD-positive" means that a relatively small number of cancer cells remain in the body during or after treatment; "MRD-negative" means that cancer cells cannot be detected in the body by traditional diagnostic techniques. negative lived longer when BLINCYTO® was used with chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”. vs chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”. alone (112 people in each group), after initial treatment. This period of treatment is known as the consolidationA phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. 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 (57%) people 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 (consolidation)A phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill anyvcancer cells that may be left in the body. in children one month and older with Ph(–) BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. is supported by data from the study above and 2 additional studies:1

  • Study of BLINCYTO® in consolidationA phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill anyvcancer cells that may be left in the body. in children aged 28 days to 18 years with Ph(–) BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. in first relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement.1
  • Study of BLINCYTO® in consolidationA phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill anyvcancer cells that may be left in the body. in young people aged 1–27 years with Ph(–) BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. in first relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement.5

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

–Ryan

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 chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”. in the consolidationA phase of treatment given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. phase of chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”.. The rest were given only chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”..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

relapse is when disease

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® +
    chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”., and 16 received chemotherapyA treatment that stops the replication of fast-growing cells throughout the body, like cancer cells, either by killing the cells or by stopping them from dividing. It is often called “chemo”. 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 relapsedThe return of a disease or the signs and symptoms of a disease after a period of improvement. or refractoryWhen a disease does not respond to treatment. BCP-ALLA fast-growing type of leukemia (blood cancer) in which too many immature white blood cells are found in the bone marrow and blood. were treated with BLINCYTO®.1

Some people had more than one relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement. before the study. Others may have had a relapseThe return of a disease or the signs and symptoms of a disease after a period of improvement. following a stem cell transplantation prior to getting BLINCYTO®, or for some their cancer may have been refractoryWhen a disease does not respond to treatment. to other treatments.1

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

had a complete response with BLINCYTO®1

Complete responseThe disappearance of all signs of cancer in response to treatment. This does not mean the cancer has been cured. 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)

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.

See side effects

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.

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.
Reference: 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. 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.
References: 1. BLINCYTO® (blinatumomab) medication guide, Amgen. 2. National Cancer Institute. Common terminology criteria for adverse events (CTCAE) version 4.0. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v4_Quick_Reference_8.5x11.pdf. Accessed April 4, 2026. 3. Shimabukuro-Vornhagen A, Gödel P, Subklewe M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6:56. 4. BLINCYTO® (blinatumomab) prescribing information, Amgen. 5. Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Bio Blood Marrow Transport. 2019;25:625-638.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 17, 2026. 3. BLINCYTO® (blinatumomab) medication guide, Amgen.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. BLINCYTO® (blinatumomab) medication guide, Amgen.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. Nagorsen D, Baeuerle PA. Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. Exp Cell Res. 2011;317:1255-1260. 3. BLINCYTO® (blinatumomab) medication guide, Amgen. 4. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 17, 2026. 5. Brüggemann M, Gökbuget N, Kneba M. Acute lymphoblastic leukemia: monitoring minimal residual disease as a therapeutic principle. Semin Oncol. 2012;39:47-57.
References: 1. BLINCYTO® (blinatumomab) prescribing information, Amgen. 2. National Cancer Institute. NCI dictionary of cancer terms. https://www.cancer.gov/publications/
dictionaries/cancer-terms. Accessed April 17, 2026. 3. Children’s Hospital of Philadelphia. Acute Lymphoblastic Leukemia (ALL). https://www.chop.edu/conditionsdiseases/acute-
lymphoblastic-leukemia-all. Accessed April 17, 2026. 4. Brüggemann M, Gökbuget N, Kneba M. Acute lymphoblastic leukemia: monitoring minimal residual disease as a therapeutic principle. Semin Oncol. 2012;39:47-57. 5. 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. 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. Nagorsen D, Baeuerle PA. Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. Exp Cell Res. 2011;317:1255-1260. 8. BLINCYTO® (blinatumomab) medication guide, Amgen.
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.
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