d protect from light until time of use. Do not freeze.
Store and transport the prepared IV bag containing BLINCYTO solution for infusion at 2°C to 8°C (36°F to 46°F) conditions. Ship in packaging that has been validated to maintain temperature of the contents at 2°C to 8°C (36°F to 46°F). Do not freeze.
17. PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide.
Advise patients to contact a healthcare professional for any of the following:
Signs and symptoms that may be associated with cytokine release syndrome and infusion reactions including pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, and wheezing [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
Signs and symptoms of neurological toxicities including convulsions, speech disorders, and confusion [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]
Signs and symptoms of infections including pneumonia [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)]
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)].
Inform patients that:
It is very important to keep the area around the intravenous catheter clean to reduce the risk of infection.
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.
[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
Close
MEDICATION GUIDE
Meication 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. |
