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

What to expect when receiving BLINCYTO®

  • IN THE HOSPITAL
  • AT HOME

How BLINCYTO® is given

BLINCYTO® is given by a continuous intravenous (IV)A way of giving a drug through a needle into a vein. infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous infusion".. This means the medicine goes into a vein and then goes into the blood. The dosing of BLINCYTO® occurs in cycles. Here's how a cycle works:1,2

diagram showing a BLINCYTO® treatment cycle with 4 weeks of continuous infusion followed by 2 weeks without treatment

One cycle is 4 weeks of infusion followed by 2 weeks without infusion. Your doctor will decide how long you will need to stay on treatment.1

How does BLINCYTO® work?

BLINCYTO® comes in a bag. It will be connected by a tube and needle. BLINCYTO® will be given by continuous IV infusion for 4 weeks and then taken off for 2 weeks.3

Timeline for treatment with BLINCYTO®

Treatment with BLINCYTO® starts in the hospital to make sure that it is safe and to watch for any side effects that may occur.3

  • You’ll be given a medicine to help reduce the likelihood of infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous infusion". reactions, which are common with BLINCYTO®3
  • You will be monitored and treated for any serious reactions to BLINCYTO®, if they happen3

One cycle of BLINCYTO® treatment is 28 days (4 weeks)1

cycle 1 of BLINCYTO® treatment

First 3 or 9 days

in the hospital (in-patient)3

cycle 2 of BLINCYTO® treatment

First 2 days

in the hospital (in-patient)3

The remaining days of the cycle may be out-patient, as determined by your health care provider3
  • After the hospital stay, your doctor will decide if the rest of the treatment can be given at home with a small portable pump3
  • Your doctor may refer you to an outpatient clinic or an infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous infusion". center to manage treatment3
  • The medicine will need to be refilled every 24 hours, 48 hours, 72 hours, 96 hours, or 7 days by a health care professional1,3
  • If additional treatment cycles of BLINCYTO® are necessary or if treatment is stopped for a period of time and restarted, treatment may also be provided in a hospital or clinic3

The length of your hospital stay will depend on whether you are receiving BLINCYTO® early after initial therapy, to treat 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., or to treat 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. that has returned or not responded to treatment.1,*

*Your doctor will determine how many days you will spend in the hospital and the number of BLINCYTO® treatment cycles you will need.1,3

BLINCYTO® is available in infusion bags designed to deliver your medicine continuously over time

After your hospital stay, your doctor will decide if you can get the rest of your treatment at home, if that is right for you. Or your doctor may refer you to an outpatient clinic or an infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous infusion". center to manage your treatment.1

BLINCYTO® outside the hospital

When you receive BLINCYTO® outside of the hospital, you will continue treatment with a small, portable intravenous (IV)A way of giving a drug through a needle into a vein. infusionA method of putting fluids, including drugs, into the bloodstream. It is also called “intravenous infusion". pump.2

BLINCYTO® is available in 5 infusion bags1

chart showing BLINCYTO® infusion refill intervals of 24 hours, 48 hours, 72 hours, 96 hours, and 7 days
chart showing BLINCYTO® infusion refill intervals of 24 hours, 48 hours, 72 hours, 96 hours, and 7 days

The times indicate how long before a bag change is needed. Your doctor will decide which bag schedule is best for you, based on a variety of factors. And someone from your health care team will assist you when it's time to change your bag.1

Can BLINCYTO® be given at home?

BLINCYTO® is started in the hospital because your doctor wants to make sure you are safe. Your doctor may decide that BLINCYTO® can be continued at home, if that is right for you. If your doctor decides this, you will learn about what happens next from your doctor. It’s possible a nurse may come to help you with the medicine.1

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

–Ryan

Talk to your health care provider about whether your IVA way of giving a drug through a needle into a vein. bag will be changed at an outpatient center or by your home health care provider.

Call your doctor if you experience any problems or side effects.

Do not change the settings on your pump, even if the alarm sounds. Any setting changes may cause a dose error.2

If you are having any problems with your pump, or pump alarm sounds, contact your health care provider immediately.2

If tubing detaches or if you detect leakage from your pump or bag, contact your health care provider immediately.

Keep BLINCYTO® and all medicines out of reach of children in the household.

Your health care provider will explain how to store and dispose of BLINCYTO® and used supplies.

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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