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.
  • 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 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 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)
  • Infections
  • Headache
  • Low red blood cell count (anemia)
  • Low white blood cell count (neutropenia)
  • Low platelet count (thrombocytopenia)

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.