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

Possible side effects

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.1

CRS is a condition that can happen when your immune system has a reaction to BLINCYTO®. It can be severe, life-threatening, or lead to death. Contact your healthcare provider or seek emergency help right away if you notice any signs and symptoms below:1-3

  • Fever
  • Tiredness or weakness
  • Dizziness
  • Headache
  • Low blood pressure
  • Nausea
  • Vomiting (throwing up)
  • Chills
  • Face swelling
  • Wheezing or trouble breathing
  • Skin rash

  • Some facts to know

    • Among people receiving BLINCYTO® in clinical trials, CRS occurred in 16% during 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 B-cell precursor ALL (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.) treatment; 7% of those in remissionA response to treatment where signs and symptoms of cancer have decreased or disappeared. This does not always mean that the cancer has been cured. with a small number of leukemiaA type of cancer that starts in blood-forming tissue, such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the bloodstream. cells remaining; and 15% of those whose disease had returned or did not respond to previous treatment4
    • In clinical trials of BLINCYTO®, patients who had CRS began experiencing symptoms a median of 2 days after starting BLINCYTO®, and in cases that resolved, these symptoms resolved a median of 5 days after they began4
    • Your doctor may temporarily or completely stop BLINCYTO®4

BLINCYTO® may cause neurologic problems that can be severe, life-threatening, or lead to death. These are issues that could harm your brain or nerves and can be dangerous. Contact your health care provider or seek emergency help right away if you experience any of the symptoms below.1,5

  • 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 swelling
  • Tremors (shakiness)

  • Some facts to know

    • In clinical trials of BLINCYTO®, around 65% of people reported neurologic issues after starting BLINCYTO®, with 13% having severe symptoms4
    • In clinical trials, patients who had neurologic problems typically experienced their first symptom within the first 2 weeks after starting BLINCYTO®. Most of these symptoms resolved after BLINCYTO® treatment was interrupted, but some resulted in treatment being discontinued4

People with Down Syndrome may have a higher risk of seizures with BLINCYTO® treatment and may be given anti-seizure medicine before starting on BLINCYTO® treatment.1

The most common side effects of
BLINCYTO® include:1

  • Fever
  • Reactions related to infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous infusion". of the medicine, such as face swelling, low blood pressure, and high blood pressure (infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous 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 other serious side effects:1

  • Infections
  • Tumor Lysis Syndrome (TLS)
  • Low white blood cell count (neutropenia)
  • Abnormal liver blood test results
  • 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 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.
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