Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I receiving Blincyto?
Blincyto contains blinatumomab. It is used to treat adults, adolescents, and children
with acute lymphoblastic leukaemia (ALL). For more information, see Section
1. Why am I receiving Blincyto? in the full CMI.
2. What should I know before I am given Blincyto?
Do not use if you have ever had an allergic reaction to Blincyto, or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. There are a number
of circumstances in which a person should not use this medicine or may need to use
caution. It is important to understand if these apply to you before receiving Blincyto
(see the full CMI for more details).
3. What if I am taking other medicines?
Some medicines may interfere with Blincyto and affect how it works.
4. How will Blincyto be given?
Blincyto is given by your doctor or nurse as an infusion.
5. What should I know while using Blincyto?
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Things you should do
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Keep all medical appointments so that your progress can be checked.
To avoid infection, keep the area around the catheter infusion clean.
Check with the doctor before having any vaccinations.
Talk to your doctor if you become pregnant or need to start breastfeeding.
Remind healthcare providers that you are receiving treatment with Blincyto.
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Things you should not do
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Do not adjust the settings on the infusion pump.
Do not breastfeed during Blincyto treatment and for 48 hours after your last dose.
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Driving or using machines
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Do not drive, engage in hazardous activity, or use any heavy machines or tools during
Blincyto treatment. Blincyto may cause dizziness, confusion, or seizures (fits).
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6. Are there any side effects?
Common side effects include headache, tingling skin or numbness, rash, cough, cold
like symptoms, shortness of breath, pale skin, bleeding or bruising more easily, trouble
sleeping, back/bone pain, pain in hands or feet, swollen joints, hands, ankles, feet,
abdomen or glands, nose bleeds, nausea, diarrhoea, vomiting, flushing, dizziness,
tremor (shaking), tiredness, weight gain.
Serious side effects include fever (temperature of 38°C or above) and signs of infection,
infusion-related reaction, allergic reaction, neurologic problems, inflammatory conditions,
metabolic disorders, pancreas inflammation and decreased white blood cells.
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WARNING: In some patients, Blincyto may cause serious side effects that can be severe,
life-threatening, or lead to death.
Call your doctor and get medical attention immediately if you experience any of the
symptoms listed below.
Fever, tiredness or weakness, dizziness, low blood pressure, headache, nausea, vomiting,
chills, face swelling, wheezing or trouble breathing, skin rash (symptoms of Cytokine
Release Syndrome and infusion reactions).
Seizures, difficulty in speaking or slurred speech, loss of consciousness, trouble
sleeping, confusion, disorientation, loss of balance, headache, difficulty with facial
movements/hearing/vision/swallowing (symptoms of neurologic problems).
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Active ingredient(s):
Blinatumomab (BLIN-a-TOOM-oh-mab)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Blincyto. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Blincyto.
Where to find information in this leaflet:
1. Why am I receiving Blincyto?
Blincyto contains the active ingredient blinatumomab. Blincyto is an antineoplastic agent which targets cancer cells. This medicine works
by enabling your immune system to attack and destroy abnormal white blood cancer cells.
Blincyto is used to treat children, adolescents, and adults with acute lymphoblastic
leukaemia (ALL). ALL is a cancer of the blood in which a particular type of white
blood cell is growing out of control.
2. What should I know before I am given Blincyto?
Warnings
Do not use Blincyto if you have an allergy to:
blinatumomab, or any of the ingredients listed at the end of this leaflet. Always
check the ingredients to make sure you can use this medicine
any medicine that is made using Chinese Hamster Ovary cells.
Tell your doctor if you:
have ever had neurological problems such as seizures, memory loss, confusion, disorientation,
loss of balance, or difficulty in speaking
have an active infection
have ever had an infusion reaction after previously using Blincyto
are pregnant or breastfeeding
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy
The effects of Blincyto in pregnant women are not known. Tell your doctor or nurse
if you think you are pregnant, or plan become pregnant. Your doctor will help you
weigh the benefit against the risk of taking Blincyto during pregnancy.
If you can become pregnant, use birth control (contraception) during treatment and
for 48 hours after your last Blincyto treatment. Talk to your doctor or nurse about
suitable methods of contraception.
Your doctor may need to talk to you about precautions in using vaccinations for your
baby.
Breastfeeding
Tell your doctor or nurse if you are breastfeeding or planning to breastfeed.
It is not known if the active ingredient of Blincyto passes into breast milk. Do not
breastfeed during Blincyto treatment and for at least 48 hours after the last treatment.
3. What if I am taking other medicines?
Tell your doctor or nurse if you think you may need any vaccinations. This includes any vaccines needed to travel to other countries. Some vaccines must
not be given 2 weeks before you start treatment with Blincyto, during your treatment,
and for some months after you received your last cycle of Blincyto.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Blincyto.
4. How will Blincyto be given?
Blincyto will always be given to you by a doctor or nurse. Before each Blincyto treatment,
you will be given other medicines (pre-medication) to help reduce any adverse reactions.
These medicines may include corticosteroids.
Your doctor or nurse will give you Blincyto as a slow, continuous infusion into a
vein (intravenous).
You will be required to stay in a hospital or clinic for up to 9 days of the first
cycle and the first 2 days of the second cycle of Blincyto. The exact duration of
your hospital stay will depend on whether you have relapsed or refractory ALL or minimal
residual disease (MRD)-positive ALL. The staff will monitor you for signs and symptoms
of any serious reactions in hospital. Follow their instructions when receiving Blincyto.
Detailed instructions on how to prepare Blincyto are included in the pack leaflet.
Your doctor, nurse, or pharmacist will prepare the IV bags or cassettes containing
Blincyto solution for infusion.
How much Blincyto will I be given
Your doctor will calculate how much Blincyto you will be given. The dose given is
based on a combination of your weight, height, and your condition.
Your doctor will determine when your Blincyto infusion bag or cassette will be changed.
This could be once daily or up to once every 4 days. The infusion rate may be faster
or slower depending on how often the bag or cassette is changed. You may not be able
to tell the difference between the different infusion rates.
For patients with relapsed or refractory ALL, the dose of Blincyto should be increased
for weeks 2, 3, and 4 of your first cycle depending on how you respond to treatment
with Blincyto. You may not be able to tell the difference between the dose delivered
during the first week of your first cycle and the increased dose delivered for the
remainder of the first cycle and for the subsequent cycles.
For patients with MRD-positive ALL, the dose should remain the same.
When Blincyto is given
Blincyto is given in repeating “cycles” lasting 6 weeks.
First 4 weeks - Blincyto is given as a continuous slow infusion into a vein (using an infusion
pump).
Next 2 weeks – Treatment break during which you will not be given the infusion.
The number of treatment cycles that will be given will depend on how well you respond
to Blincyto. Treatment may be interrupted depending on how well you tolerate Blincyto.
Your doctor will discuss how long your treatment will last.
How to manage the infusion pump
Your doctor or nurse will advise you on how to manage your daily activities around
your infusion pump. Normal everyday activities will not affect the infusion pump and
intravenous tubing.
Contact your doctor or nurse if you have questions about your daily activities and
pump function.
If you are given too much Blincyto
As Blincyto is given to you under the supervision of your doctor, it is unlikely that
you will receive too much. However, if you think you have been given too much Blincyto
or experience severe side effects after being given this medicine, tell your doctor
or nurse immediately. You may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
5. What should I know during treatment with Blincyto?
Things you should do
Keep the area around the catheter clean (if you have a catheter for infusion). This is very important, otherwise you could get an infection. Your doctor or nurse
will show you how to care for your catheter site.
Keep the area dry when showering or bathing.
Contact your doctor or nurse immediately if you have pain, discomfort, redness or
swelling around the site.
Check your temperature if you feel warm, have chills or shivering. You may have a
fever (temperature of 38°C or higher) and an infection.
Keep all medical appointments. Your doctor will do tests during treatment to check
on your progress and for any side effects.
Tell your doctor if you become pregnant while on this treatment.
If you are pregnant, your doctor may need to talk to you about precautions of receiving
vaccinations.
Tell your doctor or nurse if you think you may need any vaccinations in the near future,
including those needed to travel to other countries. Some vaccines must not be given
within two weeks before, at the same time as or in the months after you receive treatment
with Blincyto. Your doctor will check if you should have the vaccination.
Remind any doctor, dentist, or pharmacist you visit that you are using Blincyto.
Call your doctor straight away if:
there is a problem with the infusion pump or if the pump alarm sounds
the infusion bag empties before the scheduled bag change
the infusion pump stops unexpectedly. Do not try to restart the pump
if you experience seizures, difficulty in speaking or slurred speech, confusion and
disorientation, or loss of balance
if you develop chills or shivering, or feel warm; you should take your temperature
as you may have a fever – these may be symptoms of an infection
if you develop a reaction to Blincyto at any time during your infusion, which may
include dizziness, face swelling, difficulty breathing, wheezing, or rash
if you have severe and persistent stomach pain, with or without nausea and vomiting,
as these may be symptoms of a serious and potentially fatal condition known as pancreatitis
(inflammation of the pancreas).
Your doctor or nurse will monitor you for signs and symptoms of these reactions.
Your doctor or nurse will take regular blood tests to monitor your blood counts during
treatment with Blincyto.
Things you should not do
Do not adjust the settings on the infusion pump.
Do not stop or try to restart the infusion pump.
Driving or using machines
Do not drive, engage in hazardous activity, or use any heavy machines or tools while
you are being given Blincyto. Blincyto may cause dizziness, fits (seizures), and confusion in some people.
Looking after your medicine
Blincyto solution for infusion will be prepared by your pharmacist and stored in a
refrigerator at 2°C to 8°C until infusion.
Getting rid of any unwanted medicine
Do not use this medicine after the expiry date.
Your doctor, nurse or pharmacist will dispose of any unwanted medicine in accordance
with local requirements.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Blood
bleeding or bruising more easily than normal
Skin
rash
feeling of pins and needles, tingling of skin, or numbness
decreased feeling or sensitivity
flushing (feeling warm and rapid reddening of your neck, upper chest, or face)
pale skin
Eyes, ears and mouth
sore throat
mouth ulcers
Heart
fast heartbeat
Lungs and upper airway
wet or dry cough
shortness of breath when exercising
runny nose
nose bleeds
Gut and digestion
nausea
vomiting
diarrhoea
swelling in the abdomen
Brain and nerves
headache
dizziness and light headedness
tremor
Muscle and skeleton
back, chest, or bone pain
pain in hands or feet
painful/swollen joints
General
tiredness
weight increase
general swelling of the face, lips, mouth, tongue, hands, ankles or feet
swollen glands in the neck, armpit or groin
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Signs of infection:
chills or shivering, or feel warm; you should take your temperature as you may have
a fever
Signs of an infusion-related reaction:
dizziness
swelling
pain where the infusion needle is inserted
rash, blisters, itching
nausea, vomiting, constipation, diarrhoea (usually occurring within the first 48 hours)
Signs of an allergic reaction:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, mouth, tongue, throat or other parts of the body
rash, itching or hives on the skin
Signs of neurologic events:
headache
shaking (tremor)
convulsions or fits (seizures)
confusion and disorientation
difficulty in speaking, communicating, thinking or processing thoughts, or remembering
things
loss of balance, dizziness
trouble sleeping (insomnia)
visual disturbances
difficulty with facial movements, trouble swallowing
difficulty hearing
Signs of an inflammatory condition:
fever, chills
swelling
dizziness and light headedness
fluid in the lungs, which may become severe
Signs of metabolic disorders:
high fever, chills
difficulty breathing
nausea, loss of appetite, vomiting, diarrhoea
skin rash
increased or irregular heartbeat
swelling and buildup of fluids in the legs or feet
headache, confusion, disorientation, dizziness, fits (seizures), shaking (tremor),
difficulty with facial movements, trouble speaking or slurred speech, loss of balance
joint or muscle aches
Signs of pancreas inflammation:
severe and persistent stomach pain, with or without nausea and vomiting
Signs of decreased white blood cells:
fever and other signs of infection, such as shivers, chills, shakes
sore throat
difficulty or burning when passing urine
feeling unwell
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some side effects can only be found when your doctor does tests to check your progress.
These may pick up changes in:
the size of your lymph nodes, liver, or spleen
red cells, white cells, platelets, or antibodies in your blood
your blood pressure or heart rate
levels of some salts (electrolytes) or uric acid in your blood
liver enzymes or other liver test results.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Blincyto contains
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Active ingredient
(main ingredient)
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blinatumomab 38.5 micrograms
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Other ingredients
(inactive ingredients)
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citric acid monohydrate (E330)
trehalose dihydrate
lysine hydrochloride
polysorbate 80 (E433)
sodium hydroxide (E524)
water for injections
Blincyto contains less than 1 mmol (23 milligrams) sodium per dose.
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Do not take this medicine if you are allergic to any of these ingredients.
What Blincyto looks like
Each pack of Blincyto contains:
1 single-use Blincyto clear glass vial containing a sterile, preservative free, white
to off-white lyophilised powder
1 single-use IV Solution Stabiliser vial containing sterile, preservative-free, colourless-to
slightly yellow, clear solution.
(AUST R 232805)
Who distributes Blincyto
Amgen Australia Pty Ltd
Level 11, 10 Carrington St
Sydney NSW 2000
Ph: 1800 803 638
www.amgenmedinfo.com.au
This leaflet was prepared in August 2022.