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)...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 cells remain in the body (minimal residual disease)...read more

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

BLINCYTO® helps children with ALL live longer1
See how adding BLINCYTO® to the consolidation phase of chemotherapy helped children live cancer-free longer

What is BLINCYTO®?

BLINCYTO® is an immunotherapy used to treat BCP-ALL in adults and children one month or older.1

It is different from chemotherapy because it engages your immune system to find and kill cancer cells.1,2

What makes BLINCYTO® different
  1. Finds: Cancer cells can hide from healthy immune cells. BLINCYTO® helps the healthy immune cells find the cancer cells and bring them together.1
  2. Activates: When the healthy cells and cancer cells are connected, BLINCYTO® activates the healthy immune cells to release specialized proteins called granzymes.3
  3. Kills: The granzymes then attack and kill the cancer cells.3

Even after reaching remission with chemotherapy, a relatively small number of cancer cells can remain in your body that cannot be detected by traditional testing. This is called minimal residual disease, or MRD.4

There are now very sensitive and reliable tests to detect MRD, and it is important to get tested for MRD even after achieving remission.
Ask your doctor if an MRD test is right for your child.1,4

If your child* is in remission but tests positive for MRD, BLINCYTO® can help.1

  • BLINCYTO® is the first and only treatment of MRD(+) BCP-ALL for adults and children one month and older

BLINCYTO® is also approved for:1

  • Children* with Ph(–) BCP-ALL after initial treatment
  • Children* whose BCP-ALL has returned or didn't respond to treatment

The use of BLINCYTO® after initial treatment in children one month and older and adults with Ph(–) BCP-ALL is supported by data from the following studies:1

  • In a study of 224 people aged 30–70 years with newly diagnosed Philadelphia chromosome–negative (Ph(–)) BCP-ALL, half were given BLINCYTO® and chemotherapy. The other half were given only chemotherapy. The study looked at how many people were alive at 3 years† and 5 years.‡ At 3 years, 85% of people who received BLINCYTO® and chemotherapy were alive vs 69% of people who received chemotherapy only. At 5 years, 82% of people who received BLINCYTO® and chemotherapy were alive vs 63% of people who received chemotherapy only.1
  • Study of BLINCYTO® in consolidation in people aged 28 days to 18 years with Ph(–) BCP-ALL in first relapse1
  • Study of BLINCYTO® in consolidation in people aged 1–27 years with Ph(–) BCP-ALL in first relapse5

*Older than one month of age.1

†This study looked at survival for 3.6 years, and the percentage of people alive at 3 years was estimated.1

‡This study looked at survival for 4.5 years and the percentage of people alive at 5 years was estimated.1

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

In a study that included 1,400 children aged 1 to less than 10 years, about half (718 children) were given both BLINCYTO® and chemotherapy in the consolidation phase of chemotherapy. The rest were given only chemotherapy.6

At 3 years, treatment with BLINCYTO® and chemotherapy helped children live cancer-free longer vs chemotherapy alone6,*

96%

BLINCYTO® + chemotherapy (out of 718 children)

VS

88%

Chemotherapy alone (out of 722 children)

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

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

Ask your child’s doctor if BLINCYTO® is right for treating their ALL.

Possible side effects7

During treatment with BLINCYTO®, your health care provider will check for symptoms, which can be suggestive of serious side effects that can be severe, life-threatening, or lead to death.

It is also important to notify your health care provider of any side effects you may be having. If certain side effects are observed, your health care provider may change the dose, or delay, or completely stop BLINCYTO® treatment.

Serious side effects that can occur during BLINCYTO® treatment include cytokine release syndrome (CRS), infusion reactions, and neurologic problems.

Hypothetical Doctor Using a Stethoscope on Child Patient

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
  • Skin rash

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
  • Tremors

People with Down Syndrome may have a higher risk of seizures with BLINCYTO® treatment.

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

BLINCYTO® may cause the following serious side effects:

  • Infections
  • Tumor Lysis Syndrome (TLS)
  • Low white blood cell counts (neutropenia)
  • Abnormal liver blood tests
  • Inflammation of the pancreas (pancreatitis)

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.

Tell your health care provider right away if you develop an infection or fever, or if you have any side effects that bother you or do not go away.

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.
    • 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.
      • 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.
  • 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.

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 January 9, 2025. 3. Nagorsen D, Baeuerle PA. Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. Exp Cell Res. 2011;317:1255-1260. 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. 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;325:833-842. 6. Gupta S, Rau RE, Kairalla JA, et al. Blinatumomab in standard-risk B-cell acute lymphoblastic leukemia in children. N Engl J Med. Published online December 7, 2024. doi:10.1056/NEJMoa2411680. 7. BLINCYTO® (blinatumomab) medication guide, Amgen.