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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 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 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 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 abdominal 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:
  • Infections
  • Fever
  • Headache
  • 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.

INDICATION

BLINCYTO^® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable 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 are ongoing studies to confirm clinical benefit.