the setting on the infusion pump. Any changes to pump function may result in dosing errors. If there is a problem with the infusion pump or the pump alarms, patients should contact their doctor or nurse immediately.
[Amgen Logo]
BLINCYTO (blinatumomab)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License No. 1080
Patent: http://pat.amgen.com/blincyto/
© 2014 Amgen Inc. All rights reserved.
1xxxxxx- v1
Medication Guide
BLINCYTO™ (blin sye' toe)
(blinatumomab)
for injection
Read this Medication Guide before you receive BLINCYTO and before each BLINCYTO infusion. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about BLINCYTO?
Call your healthcare 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
•skin rash
•Neurologic problems. Symptoms of neurologic problems may include:
•seizures
•difficulty in speaking or slurred speech
•loss of consciousness
•confusion and disorientation
•loss of balance
Your healthcare provider will check you for these problems during treatment with BLINCYTO. Your healthcare provider may temporarily stop or completely stop your treatment with BLINCYTO, if you have severe side effects.
See “What are the possible side effects of BLINCYTO?” below for other side effects of BLINCYTO.
What is BLINCYTO?
BLINCYTO is a prescription medicine used to treat a certain type of acute lymphoblastic leukemia (ALL). Acute lymphoblastic leukemia is a cancer of the blood in which a particular kind of white blood cell is growing out of control.
There is limited experience in using BLINCYTO in children.
Who should not receive BLINCYTO?
Do not receive BLINCYTO if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO. See the end of this Medication Guide for a complete list of ingredients in BLINCYTO.
What should I tell my healthcare provider before receiving BLINCYTO?
Before you receive BLINCYTO, tell your healthcare provider about all of your medical conditions, including if you:
•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.
•are pregnant or plan to become pregnant. BLINCYTO may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with BLINCYTO.
•are breastfeeding or plan to breastfeed. It is not known if BLINCYTO passes into y