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 and difficulty with facial movements, hearing, vision, or swallowing.
- 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®.
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.
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 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 during treatment with BLINCYTO®, and for at least 48 hours after the 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 at least 48 hours after your last treatment.
- Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- 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.
- 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 count during treatment with BLINCYTO®. Tell your health care provider right away if you get a fever.
- Abnormal liver blood tests. 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 people 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 of BLINCYTO® include:
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- low white blood cell count with fever (febrile neutropenia)
- low platelet count (thrombocytopenia)
- reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
- 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.
BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in patients with remaining traces of cancer after chemotherapy.
The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.