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

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

What makes BLINCYTO® different

Cancer Cell

BLINCYTO® is an immunotherapy that helps fight acute lymphoblastic leukemia (ALL). It is different from chemotherapy. An immunotherapy is a type of medicine that uses your body’s own immune system to find and destroy cancer cells.1,2

Some other treatment options

Chemotherapy: A treatment that uses one or more drugs to either kill the cancer cells or stop them from dividing.2

Stem cell transplant: A procedure for replacing the cells of the bone marrow harmed by disease with healthy cells.2

Targeted therapy: A treatment that identifies and attacks certain types of cancer cells with less harm to normal cells. Some block specific actions of cancer cells, while others help the immune system kill cancer cells.2,3

CAR T-cell therapy: A type of immunotherapy in which a person’s T cells (a type of cell in the immune system) are removed from their body, changed in the laboratory to recognize and attack cancer cells, and then given back to the person through an intravenous infusion. The process for CAR T-cell manufacturing can take up to three weeks.2,4

CAR, chimeric antigen receptor.

BLINCYTO® was studied in 224 people aged 30–70 years with newly diagnosed Ph(–) BCP-ALL. The study took place in the consolidation phase of chemotherapy. Half of the people were given BLINCYTO® with chemotherapy and the other half received chemotherapy only.1

Treatment with BLINCYTO® and chemotherapy helped people live longer vs chemotherapy alone1

Person Icon

At 3 years, 85% of 112 people who received BLINCYTO® with chemotherapy were still alive vs 69% of 112 people who received chemotherapy alone.1,*

At 5 years, more people who received BLINCYTO® and chemotherapy were still alive vs chemotherapy alone1,5,†

82%

BLINCYTO® + chemotherapy (out of 112 people)

VS

63%

Chemotherapy alone (out of 112 people)

In this study, most people were given 4 cycles of BLINCYTO®. Your doctor will decide how long you will need to stay on treatment.6

4 Cycle Infusion Icon

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

†This analysis looked at survival for 4.5 years, and the percentage of people alive at 5 years was estimated.1,5

BLINCYTO® and MRD

Even after achieving remission with chemotherapy, a relatively small number of cancer cells can remain in your body, known as minimal residual disease (MRD). We refer to this as MRD-positive. MRD-negative means there are no detectable traces of cancer left.7

MRD-negative | MRD-positive
MRD-negative | MRD-positive

In another trial, BLINCYTO® was studied in 86 adults with BCP-ALL who tested MRD-positive after chemotherapy. This means that there were remaining cancer cells in their body. The goal was to become MRD-negative so there were no detectable traces of cancer left. Let's see how well it worked.1

BLINCYTO® helped most people who were MRD-positive become MRD-negative1,*

8 out of 10 (81%) had no detectable cancer after 4 weeks1,†,‡

81% of People

More than half of the people treated with BLINCYTO® were able to go on to transplant1,§

*As measured by a test that can detect 1 cancer cell out of 10,000 cells in the bone marrow.1 (More sensitive testing methods may be able to detect lower levels of cancer cells.)7

†Adults studied had at least 3 rounds of chemotherapy prior to treatment with BLINCYTO®. They were in complete remission either for the first or second time.
Remission is a response to treatment where signs of cancer have disappeared, but this does not always mean the cancer is cured.1,2

‡One cycle of treatment with BLINCYTO® consists of four weeks of treatment followed by two weeks without treatment.1

§59 out of 86 people treated with BLINCYTO® in the study proceeded to a stem cell transplant.1

Possible side effects8

BLINCYTO® may cause serious side effects that can be severe, life-threatening, or lead to death. These include cytokine release syndrome (CRS), infusion reactions, and neurologic problems.

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 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

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 over the age of 10 years 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 June 25, 2024. 3. American Cancer Society. Targeted therapy. https://www.cancer.org/cancer/managing-cancer/treatment-types/targeted-therapy.html. Accessed August 7, 2024. 4. Hay KA, Turtle CJ. Chimeric antigen receptor (CAR) T cells: lessons learned from targeting of CD19 in B cell malignancies. Drugs. 2017;77:237-245. 5. Data on file, Amgen; [1]; 2024. 6. Data on file, Amgen; [2]; 2024. 7. Brüggemann M, Gökbuget N, Kneba M. Acute lymphoblastic leukemia: monitoring minimal residual disease as a therapeutic principle. Semin Oncol. 2012;39:47-57. 8. BLINCYTO® (blinatumomab) medication guide, Amgen.