Blinatumomab is a cancer treatment for adults and children with certain types of acute lymphoblastic leukemia (ALL).   ALL is a cancer of the blood which has one type of white blood cell that is growing out of control.

Blinatumomab is a monoclonal antibody which is a type of "targeted" cancer therapy. It targets specific proteins on the surface of the cancer cells. This tells your immune system to find and destroy cancer cells, which helps you to live longer.

Monoclonal antibodies only target specific cells so they may be less toxic to healthy cells.

What is blinatumomab used for?

Blinatumomab is a medicine given as an intravenous infusion to treat adults and children with:

• B-cell precursor acute lymphoblastic leukemia (ALL) which is in remission with molecular evidence of leukemia
• B-cell precursor ALL that has come back after treatment or did not respond well to earlier treatments.

Call your healthcare provider or get emergency medical help right away if you get any of the symptoms listed below.

Blinatumomab 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
  • vomiting
  • tiredness or weakness
  • chills
  • dizziness
  • face swelling
  • headache
  • wheezing or trouble breathing
  • low blood pressure
  • skin rash
  • nausea
• Neurologic problems. Symptoms of neurologic problems may include:
  • seizures
  • loss of balance
  • difficulty in speaking or slurred speech
  • headache
  • loss of consciousness
  • difficulty with facial movements, hearing, vision, or swallowing
  • trouble sleeping
  • confusion and disorientation

Your healthcare provider will check for these problems during treatment with this medicine. Your healthcare provider may temporarily stop or completely stop your treatment, if you have severe side effects.

See “What are the side effects of blinatumomab?” below on this page for other side effects of this medicine.

Blinatumomab will be given to you by intravenous (IV) infusion into your vein by an infusion pump.

Your healthcare provider will decide the number of treatment cycles of blinatumomab.

• You will receive blinatumomab by continuous IV infusion for 4 weeks (28 days), followed by a 2 week (14 days) break during which you will not receive this medicine. This is 1 treatment cycle (42 days).

Your healthcare provider may prescribe continued therapy.

• You will receive blinatumomab by continuous 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 treatment cycle (84 days).

Your healthcare provider may give you this medicine in a hospital or clinic for the first 3 to 9 days of the first treatment cycle and for the first 2 days of the second cycle to check you for side effects. If you receive additional treatment cycles of blinatumomab or if your treatment is stopped for a period of time and restarted, you may also be treated in a hospital or clinic.

Your healthcare provider may change your dose of blinatumomab, delay, or completely stop treatment with this medicine if you have certain side effects.

Your healthcare provider will do blood tests during treatment with this medicine to check you for side effects.

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

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.

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.

Your dose of blinatumomab will depend on which condition you are treating, your age, weight and whether you are in the induction cycle or the consolidation cycle.

Your dose may change or be stopped if you start having side effects.

Do not receive this medicine if you are allergic to blinatumomab or to any of the inactive ingredients of this medicine. See the end of this page for a complete list of ingredients in this preparation.

What should I tell my doctor before receiving blinatumomab?

Before receiving this medicine, tell your healthcare provider about all of your medical conditions, including if you or your child being treated:

• have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance
• have an infection
• have ever had an infusion reaction after receiving blinatumomab 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 this medicine, during treatment, and until your immune system recovers after you receive your last cycle of blinatumomab. If you are not sure about the type of vaccine, ask your healthcare provider.
• are pregnant or plan to become pregnant. Blinatumomab may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with this medicine. See below for more information on blinatumomab and pregnancy 
• are breastfeeding or plan to breastfeed. It is not known if blinatumomab passes into your breast milk. You should not breastfeed during treatment with blinatumomab and for 48 hours after your last treatment. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving blinatumomab because it can cause neurological symptoms, such as dizziness, seizures, and confusion.

What are the serious side effects caused by Blinatumomab? 

• See “Important information” above on this page.
• Infections. blinatumomab may cause life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.
• Low white blood cell counts (neutropenia). Neutropenia is common with blinatumomab treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell count during treatment with this medicine. Tell your healthcare provider right away if you get a fever.
• Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start this medicine 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.

What are the most common side effects of blinatumomab?

• infections
• low platelet count (thrombocytopenia)
• fever
• reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
• headache
• low red blood cell count (anemia)

These are not all the possible side effects of blinatumomab.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.