are receiving BLINCYTO because BLINCYTO can cause neurological symptoms such as dizziness, seizures, and confusion.
What are the possible side effects of BLINCYTO?
See “What is the most important information I should know?”
BLINCYTO may cause serious side effects, including:
Infections. BLINCYTO may cause life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop 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. Tell your healthcare provider right away if you get a fever.
Abnormal liver blood test. Your healthcare provider will do blood tests before you start BLINCYTO and during treatment with BLINCYTO to check your liver.
The most common side effects of BLINCYTO include:
fever
headache
swelling of hands, ankles or feet
nausea
constipation
shaking (tremor)
rash
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side of effects of BLINCYTO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store BLINCYTO?
Intravenous bags containing BLINCYTO for infusion will arrive in a special package.
Do not open the package.
Do not freeze the package.
The package containing BLINCYTO will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 8 days.
Do not throw away (dispose of) any BLINCYTO in your household trash. Talk with your healthcare provider about disposal of BLINCYTO and used supplies.
Keep BLINCYTO and all medicines out of reach of children.
General information about BLINCYTO
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BLINCYTO for a condition for which it was not prescribed. Do not give BLINCYTO to other people even if they have the same symptoms that you have. It may harm them.
If you would like more information about BLINCYTO, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BLINCYTO that is written for health professionals.
For more information, go to www.blincyto.com or call Amgen at 1-800-772-6436.
What are the ingredients in BLINCYTO?
Active ingredient: blinatumomab
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dehydrate, sodium hydroxide and water for injection.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
Issued: 12/2014
© 2014 Amgen Inc. All rights reserved.
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PRINCIPAL DISPLAY PANEL
1 BLINCYTOTM Single Use Vial
1 IV Solution Stabilizer Vial
NDC 55513-160-01
AMGEN®
BLINCYTOTM
(blinatumomab)
for Injection
35 mcg/vial
35 mcg/vial
For Intravenous Infusion Only
Store at 2°C to 8°C (36°F to 46°F).
Store in carton to protect from light.
DO NOT SHAKE reconstituted solution.
Dispense the enclosed Medication Guide to each patient.
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