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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I being given Besponsa?
Besponsa contains the active ingredient inotuzumab ozogamicin. Besponsa is used to
treat adults with acute lymphoblastic leukaemia (ALL). ALL is a cancer of the blood
where the cells that help protect your body from infection and foreign materials (white
blood cells) grow uncontrollably. For more information, see Section
1. Why am I being given Besponsa? in the full CMI.
2. What should I know before receiving Besponsa?
Do not receive Besponsa if you have ever had an allergic reaction to Besponsa or any
of the ingredients listed at the end of the CMI, or have had severe confirmed venoocclusive
disease, or have serious ongoing liver disease.
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. For more information, see Section
2. What should I know before receiving Besponsa? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Besponsa and affect how it works. Tell your doctor
or pharmacist if you are taking any other medicines, including any medicines, vitamins
or supplements that you buy with or without a prescription from your pharmacy, supermarket
or health food shop. A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How is Besponsa given?
Besponsa is given in "cycles". One Besponsa treatment cycle is made up of a single
Besponsa dose given each week for 3 weeks. A doctor or nurse will give you your Besponsa
dose gradually over 1 hour through a drip in your vein. More instructions can be found
in Section
4. How is Besponsa given? in the full CMI.
5. What should I know while receiving Besponsa?
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Things you should do
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Remind any doctor, surgeon, dentist and pharmacist you visit that you are receiving
Besponsa.
Keep all of your doctor’s appointments so that your progress can be checked.
Use a proven method of birth control during treatment with Besponsa if you can become
pregnant or if you can father a child. You must continue to use effective birth control
for at least 8 months (women) or at least 5 months (men) after the last dose of Besponsa.
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Things you should not do
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You must avoid becoming pregnant or fathering a child whilst receiving Besponsa
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Driving or using machines
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This medicine may cause fatigue in some people. If you feel tired, do not drive, operate
machinery or do anything else that could be dangerous.
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Looking after your medicine
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Besponsa must be kept in the original packaging in a refrigerator, protected from
light, before it is time to use it. Your doctor, nurse or pharmacist will prepare
the infusion for you before you are given it.
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6. Are there any side effects?
Common side effects may include: nausea, vomiting, diarrhoea, constipation, decreased
appetite, headache, general weakness, mouth ulcer, redness or pain.
Serious side effects may include: rapid weight gain, pain in the upper right side
of stomach, a yellowish colour of the eyes and skin, changes in heart rhythm, decreased
urine, blood in urine, muscle spasms, weakness, cramps, fever, sweating, chills, bruising
easily or getting regular nose bleeds, lightheadedness, rash or trouble breathing
shortly after receiving the injection. For more information, including what to do
if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
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WARNING:
Hepatotoxicity, including fatal and life‐threatening hepatic venoocclusive disease
has occurred in patients treated with BESPONSA.
An increased risk of post‐haematopoietic stem cell transplant (HSCT) non-relapse mortality
has been observed in patients treated with BESPONSA.
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Active ingredient:
Inotuzumab ozogamicin (rch)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about Besponsa.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about Besponsa.
Where to find information in this leaflet:
1. Why am I being given Besponsa?
The active ingredient in Besponsa is inotuzumab ozogamicin. It belongs to a group
of medicines called antineoplastic agents that target cancer cells.
Besponsa is used to treat adults with acute lymphoblastic leukaemia (ALL). ALL is
a cancer of the blood where the cells that help protect your body from infection and
foreign materials (white blood cells) grow uncontrollably.
This medicine works by stopping the abnormal growth of these cells and destroying
them.
2. What should I know before receiving Besponsa?
Warnings
Do not receive Besponsa if you:
have had severe confirmed venoocclusive disease (a condition in which the blood vessels
in the liver become damaged and blocked by blood clots) or you currently have this
disease
have serious ongoing liver disease (e.g., cirrhosis [a condition in which the liver
does not function properly due to long-term damage], nodular regenerative hyperplasia
[a condition with signs and symptoms of portal hypertension that can be caused by
chronic use of medicines], active hepatitis [a disease characterised by inflammation
of the liver])
are allergic to inotuzumab ozogamicin, or any of the ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can receive this medicine. See Section
7. Product details for a list of ingredients
Check with your doctor if you:
have any other medical conditions such as:
liver problems
heart problems
an infection or fever or bruising easily or getting nose bleeds on a regular basis.
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 and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant, are breastfeeding
or intend to breastfeed.
It is unlikely that you will be given this medicine if you are pregnant or trying
to become pregnant, as it may harm your unborn baby. Your doctor can discuss with
you the risks involved.
You must avoid becoming pregnant or fathering a child if you are being treated with
Besponsa.
It is not known whether this medicine passes into breast milk.
A risk to the newborn/infant cannot be excluded therefore you should not breastfeed
during treatment with Besponsa and for at least 2 months after your last dose.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, vitamins or
supplements that you buy with or without a prescription from your pharmacy, supermarket
or health food shop.
Some medicines may be affected by Besponsa or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor will advise you.
There are certain periods before, during and after Besponsa treatment where live vaccines
are not recommended. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure if the medicine(s), vitamin(s)
or supplement(s) you are taking are affected by Besponsa or may affect how Besponsa
works.
4. How is Besponsa given?
Besponsa is given in "cycles". One Besponsa treatment cycle is made up of a single
Besponsa dose given each week for 3 weeks.
A doctor or nurse will give you your Besponsa dose gradually over 1 hour through a
drip in your vein (intravenous infusion).
How much is given
Your doctor will calculate how much you need to be given.
This will depend on your height and weight and may also depend on your condition and
how you have responded to previous treatment.
Medicines given before each cycle
Before each treatment with Besponsa, you will be given other medicines (premedication)
to help reduce symptoms such as fever, chills or hot flush, known as infusion reactions,
and other possible side effects.
How long it is given
If the medicine works well and you are going to receive a stem cell transplant, you
may receive 2 cycles or a maximum of 3 cycles of treatment.
If the medicine works well, but you are not going to receive a stem cell transplant,
you may receive up to a maximum of 6 cycles of treatment.
If you do not respond to the medicine within 3 cycles, your treatment will be stopped.
Your doctor will discuss with you how long your treatment will last.
If you forget a treatment
If you miss a treatment, contact your doctor or nurse as soon as possible to make
a new appointment.
If you are given too much (overdose)
It is unlikely that you will be given too much Besponsa, as your dose will be calculated
and given to you in a specialised setting under the supervision of a doctor.
If you think that you have been given too much Besponsa, you may need urgent medical
attention.
If there are no signs of discomfort or poisoning but you still think that you have
been given too much Besponsa, and you are in contact with a doctor, you should follow
your doctor’s advice.
If you are unable to reach your treating doctor, then go to the emergency department
at your nearest hospital.
5. What should I know while receiving Besponsa?
Things you must do
If you (or your partner) become pregnant while you are being given this medicine,
tell your doctor immediately.
You must avoid becoming pregnant or fathering a child.
Use a proven method of birth control (contraception) during treatment with Besponsa
if you can become pregnant or if you can father a child.
You must continue to use effective birth control for at least 8 months (women) or
at least 5 months (men) after the last dose of Besponsa.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are being treated with Besponsa.
Tell all doctors, dentists, and pharmacists who treat you that you are being given
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will take regular blood tests to make sure Besponsa is working and to
check for side effects.
In particular, your blood counts and liver function will need to be checked before
each treatment.
Your doctor will also monitor your heart rhythm, the levels of certain electrolytes
(such as calcium, magnesium, potassium) in your blood, and the level of enzymes (known
as amylase and lipase) in your blood.
Your doctor may change your dose, interrupt, or completely stop treatment with this
medicine if you have certain side effects.
Your doctor may also lower your dose based on your response to treatment.
Tell your doctor immediately if you have had any of the following symptoms during
or shortly after being given Besponsa:
fever, chills, hot flush, dizziness or lightheadedness, rash or trouble breathing
nausea, vomiting, diarrhoea, changes in heartbeat, decreased urine or blood in urine,
muscle weakness or cramps.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Besponsa
affects you.
This medicine may cause fatigue in some people. If you feel tired, do not drive, operate
machinery or do anything else that could be dangerous.
Drinking alcohol
No information available.
Tell your doctor if you drink alcohol.
Storage
Besponsa must be kept in the original packaging in a refrigerator, protected from
light, before it is time to use it.
Your doctor, nurse or pharmacist will prepare the infusion for you before you are
given it. They may give it to you straight away or within 8 hours after the start
of preparation.
Your doctor, nurse and pharmacist have more information on how to store Besponsa.
Disposal
Your doctor, nurse or pharmacist will dispose of any left-over medicine.
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 if you have any further
questions about side effects.
Common side effects
The above list includes the more common side effects of your medicine.
Some side effects (for example, changes in your liver function) can only be found
when your doctor does tests from time to time to check your progress.
Serious side effects
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Serious side effects
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What to do
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rapid weight gain, pain in the upper right side of your abdomen (stomach), a yellowish
colour of the skin, eyes, and other tissues
These could be symptoms of a very serious and potentially fatal condition called venoocclusive
liver disease.
If you are over 65 years of age, have a prior history of liver disease and/or hepatitis,
have previously received a stem cell transplant (a process that involves replacing
blood-forming cells called stem cells that are diseased or have been damaged by anti-cancer
medicines), and/or have received several prior treatments, you have an increased chance
of getting this side effect.
symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea),
heart (for example, changes in the rhythm), kidney (for example, decreased urine,
blood in urine), and nerves and muscles (for example, muscle spasms, weakness, cramps)
These could be signs of a serious condition known as tumour lysis syndrome, which
is caused by chemical disturbances in the blood due to the breakdown of dying cancer
cells.
fever, sweating and chills
These could be signs of an infection which may be serious and potentially fatal.
bruising easily or getting nose bleeds on a regular basis
fever, chills, hot flush, dizziness or lightheadedness, rash or trouble breathing
during or shortly after the Besponsa infusion (infusion-related reactions)
dizziness, feeling lightheaded, or fainting
These could be signs of a heart rhythm disorder that can cause serious irregular heart
rhythms.
Symptoms of an allergic reaction such as:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives.
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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.
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 Besponsa contains
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Active ingredient
(main ingredient)
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inotuzumab ozogamicin
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Other ingredients
(inactive ingredients)
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Sucrose
Trometamol
Polysorbate 80
Sodium chloride
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Do not take this medicine if you are allergic to any of these ingredients.
What Besponsa looks like
Besponsa is a white or off-white powder or cake supplied in a glass vial (AUST R 288135).
Before Besponsa is given, the powder is mixed with sterile water and diluted with
a solution of sodium chloride.
Each Besponsa carton contains 1 vial.
Who distributes Besponsa
Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free Number: 1800 675 229.
This leaflet was prepared in November 2024
® = Registered Trademark