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BLINCYTO- blinatumomab kit


  1. Patient Information
  2. Manufactured By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Cytokine Release Syndrome (CRS)
Advise patients of the risk of CRS and infusion reactions, and to contact their healthcare professional for signs and symptoms associated with CRS or infusion reactions (pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, and wheezing)[see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Neurological Toxicities
Advise patients of the risk of neurological toxicities, and to contact their healthcare professional for signs and symptoms associated with this event (convulsions, speech disorders, and confusion)[see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

Infections
Advise patients of the risk of infections, and to contact their healthcare professional for signs or symptoms of infection[see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

Inform patients of the importance of keeping the skin clean around the intravenous catheter to reduce the risk of infection.

Pancreatitis
Advise patients of the risk of pancreatitis and to contact their healthcare provider for signs or symptoms of pancreatitis, which include severe and persistent stomach pain, with or without nausea and vomiting[see Warnings and Precautions (5.8) and Adverse Reactions (6.2)].

Driving and Engaging in Hazardous Occupations
Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered. Patients should be advised that they may experience neurological events[see Warnings and Precautions (5.6)].

Infusion Pump Errors
Inform patients they should not adjust 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.

BLINCYTO(blinatumomab)

Manufactured By: 


Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080

Patent: http://pat.amgen.com/blincyto/

2014-2019 Amgen Inc. All rights reserved.

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