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.

[Amgen Logo]

Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799

Issued: 12/2014

© 2014 Amgen Inc.  All rights reserved.

1xxxxxx – v1

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.

No Preservative

Single Use Vial –

Discard unused portion.

Rx Only
BLINCYTO 
blinatumomab kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55513-160
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55513-160-01 1 in 1 PACKAGE; Combination Product Type = C112160  
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL  3.088 mL
Part 2 1 VIAL  10.6 mL
Part 1 of 2
BLINCYTO 
blinatumomab injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLINATUMOMAB (BLINATUMOMAB)  BLINATUMOMAB 12.5 ug  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 1.19 mg  in 1 mL
LYSINE HYDROCHLORIDE 8.27 mg  in 1 mL
POLYSORBATE 80 0.