Important Safety Information
What is the most important information I should know about BLINCYTO®?
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Call your health care provider or get emergency medical help right away if you get any of the symptoms listed below:
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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.
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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
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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.
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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®.
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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®?
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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:
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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.
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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.
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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®.
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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.
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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:
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- 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.