Blinatumomab

Pronunciation: blin-a-too-mo-mab
Generic name: blinatumomab
Brand name: Blincyto
Dosage form: injection for intravenous infusion
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 8, 2024.

What is blinatumomab?

Blinatumomab (Blincyto) is an injectable immunotherapy treatment that may be used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 month and older. It is a biologic treatment that is usually given after other cancer treatments have been tried without success.

Blinatumomab's mechanism of action is to connect the protein CD3 found on the surface of T cells (a type of white blood cell that is an essential part of our immune system) to another protein, CD19 found on cancerous and non-cancerous B-cells. This activates the T-cell and blinatumomab works by causing the destruction (lysis) of CD19 cells. Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. In one study, 81% of patients with B-cell precursor ALL with minimal residual disease receiving blinatumomab had no detectable cancer after 4 weeks.

Blinatumomab was FDA-approved on December 3, 2014 under the brand name Blincyto. There is no generic blinatumomab available.

What is blinatumomab used for?

Blinatumomab is used to treat adults and children 1 month and older with:

• B-cell precursor ALL in remission when only a small number of cancer cells remain in the body (minimal residual disease [MRD])
• 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.

It is not known if blinatumomab is safe and effective in children under 1 month of age.

Blinatumomab side effects

The most common side effects of blinatumomab include:

• fever
• infusion-related reactions (see below)
• headache
• infections
• muscle, joint, and bone pain
• low white or red blood cell counts (neutropenia or anemia)
• low platelet count (thrombocytopenia)
• diarrhea.

Some side effects may occur during the blinatumomab injection. Tell your healthcare provider right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to blinatumomab such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Blinatumomab may cause serious side effects, including:

Cytokine release syndrome (CRS) and infusion reactions. CRS can occur when your immune system responds to immunotherapy medications such as blinatumomab more aggressively than it should and symptoms may be similar to infusion reactions. Tell your healthcare provider right away if you develop a fever, chills, wheezing or difficulty breathing, dizziness, headache, low blood pressure, nausea or vomiting, body aches, diarrhea, facial swelling, a skin rash, or feel tired or light-headed.

Neurologic problems. Blinatumomab may affect your nerves and can cause some serious neurological disorders including a potentially life-threatening neurotoxicity called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your healthcare provider right away if you experience:

• 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 over the age of 10 years may have a higher risk of seizures with blinatumomab.

Life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.

Tumor Lysis Syndrome (TLS) is caused by the fast breakdown of cancer cells. It 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 blinatumomab, 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) are common with blinatumomab treatment and may sometimes be life-threatening. They can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell counts during treatment. Tell your healthcare provider right away if you get a fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands or feet, or feel light-headed or short of breath.

Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start blinatumomab and during treatment.

Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with blinatumomab and corticosteroids. It may be severe and lead to death. Tell your healthcare 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.

People receiving blinatumomab are at risk of seizures or losing consciousness and should not drive or engage in hazardous activities.

Blinatumomab may harm an unborn baby and should not be taken by females who are pregnant.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

You should not use blinatumomab if you are allergic to blinatumomab, blinatumomab, or any inactive ingredients in the injection.

To make sure blinatumomab is safe for you, tell your doctor if you have:

• nerve problems or a neurologic disorder, such as seizures, confusion, trouble speaking, or problems with balance
• Down syndrome
• a history of chemotherapy or radiation treatment to your brain
• an infection
• have recently received a vaccine or if you are scheduled for a booster dose
• are pregnant or plan to become pregnant
• are breastfeeding.

Pregnancy

Blinatumomab may harm an unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with blinatumomab. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with blinatumomab, and for 48 hours after their last dose. Do not use blinatumomab if you are pregnant. If you inadvertently become pregnant while receiving blinatumomab, tell your healthcare provider right away.

Breastfeeding

It is not known if blinatumomab passes into your breast milk. You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

How is blinatumomab administered?

Blinatumomab will be given to you by a continuous intravenous (IV) infusion into your vein using a small portable infusion pump. This means you can still carry out daily activities as normal, although you should be careful not to drive or engage in hazardous tasks while receiving the infusion.

• One induction treatment cycle is usually 4 weeks (28 days) of continuous infusion followed by 2 weeks (14 days) break without infusion.
• For the first 3 to 9 days of the first cycle and the first 2 days of the second cycle, you will usually receive this in a hospital under the care of your healthcare provider.
• For the rest of the cycle, your healthcare provider will decide if you receive your treatment at home or through an outpatient clinic or infusion center.
• Your healthcare provider will decide the number of treatment cycles of blinatumomab but a treatment course for MRD is usually 1 cycle of blinatumomab for induction followed by up to 3 additional cycles for consolidation (continued therapy). This usually consists of one IV infusion for 4 weeks (28 days), followed by an 8-week (56 days) break during which you will not receive blinatumomab. This is 1 consolidation treatment cycle (84 days).
• Your healthcare provider may change your dose of blinatumomab, delay, or completely stop treatment if you have certain side effects, and do blood tests during treatment to check you for side effects.

Before receiving blinatumomab, you will be given a corticosteroid medicine to help reduce infusion reactions.

Before and during treatment, you may be given chemotherapy as an injection into the space that
surrounds the spinal cord and the brain (intrathecal injection) to help prevent central nervous system relapse of ALL.

• It is very important to keep the area around the IV catheter clean to reduce the risk of getting an infection. Your healthcare provider will show you how to care for your catheter site.

Receiving blinatumomab at home

If your healthcare provider has decided you can receive blinatumomab at home, your infusion bag will be changed at an outpatient center or by your home healthcare provider.

• Blinatumomab is available in 24-hour, 48-hour, and 7-day infusion bags. Your bag will need to be changed every day, every 2 days, or once a week based on what your doctor decides is best for you.
• Call your doctor if you experience any problems or side effects.
• Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your infusion pump settings may cause a dose that is too high or too low to be given.
• Call your healthcare provider or nurse right away if you have any problems with your pump or your pump alarm sounds.
• Keep blinatumomab out of reach of children or pets in the household.

What happens if I miss a dose?

Call your healthcare provider if you do not receive your IV bags on time or if your home healthcare provider does not change the infusion bag in time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fever, tremors, and headache.

What should I avoid while using blinatumomab?

Do not receive a "live" vaccine while using blinatumomab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Ask your doctor how soon it is safe for you to receive a vaccine after you stop using this medicine.

Avoid driving or hazardous activity until you know how blinatumomab will affect you. blinatumomab increases your risk of seizures, losing consciousness, and a serious nerve toxicity syndrome called ICANS (see above).

What other drugs will affect blinatumomab?

Other drugs may interact with blinatumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

No formal drug interaction studies have been conducted with blinatumomab. The highest drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle. People receiving medications with a narrow therapeutic index metabolized by the cytochrome p450 system, such as warfarin or cyclosporin should be monitored for increases in side effects and the dosage of the interacting drug adjusted if needed.

No formal drug interaction studies have been conducted with blinatumomab, but starting blinatumomab treatment causes the short-lived release of cytokines that may suppress CYP450 enzymes and affect medications with a narrow therapeutic index, such as warfarin.

Storage

Intravenous (IV) bags containing blinatumomab for infusion will arrive in a special package.

• Do not open the package.
• Do not freeze the package.

The package containing blinatumomab will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C).

The prepared preservative-free blinatumomab infusion bag lasts for 48 hours at room temperature 73°F to 81°F (23°C to 27°C) or 8 days when refrigerated at 36°F to 46°F (2°C to 8°C).

The prepared preservative-containing blinatumomab infusion bag lasts for 7 days at room temperature 73°F to 81°F (23°C to 27°C) or 14 days when refrigerated at 36°F to 46°F (2°C to 8°C).

Do not throw away (dispose of) any blinatumomab in your household trash. Talk with your healthcare provider about the disposal of blinatumomab and used supplies.

Keep out of reach of children.

Blinatumomab infusion ingredients

Active ingredient: blinatumomab.
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dihydrate, sodium hydroxide, and preservative-free sterile water for injection.
Inactive ingredients of IV Solution Stabilizer: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide, and water for injection.

Due to the addition of bacteriostatic saline, 7-day bags of blinatumomab solution for infusion with a preservative contain benzyl alcohol and are not recommended for use in patients weighing less than 22 kg.

Available as blinatumomab 35 mcg in a single-dose vial for reconstitution.

Who makes blinatumomab?

Amgen Inc. makes blinatumomab 35 mcg single-dose vials for reconstitution, under the brand name Blincyto.

Blinatumomab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for blinatumomab.

Popular FAQ

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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