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BLENREP
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. Important safety information about eye-related
issues is provided in the full CMI. Read before using this medicine.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
BLENREP contains the active ingredient belantamab mafodotin. BLENREP is used to treat
multiple myeloma.
For more information, see Section 1. Why am I being treated with BLENREP? in the full CMI.
For more information, see Section 1. Why am I being treated with BLENREP? in the full CMI.
Do not use if you have ever had an allergic reaction to BLENREP 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.
For more information, see Section 2. What should I know before I am treated with BLENREP? in the full 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.
For more information, see Section 2. What should I know before I am treated with BLENREP? in the full CMI.
Some medicines may interfere with BLENREP and affect how it works.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.
BLENREP will be given to you in a hospital or clinic under the supervision of a doctor
experienced in cancer treatment. More instructions can be found in Section 4. How will BLENREP be given to me? in the full CMI.
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist you visit that you are being treated
with BLENREP.
Apply lubricating and moistening eye drops (preservative-free artificial tears) during
treatment.
Contact your doctor if you develop any side effects or symptoms that worry you.
Attend all scheduled appointments and tell your doctor or nurse before you receive
another infusion if you have developed any infusion-related reactions.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are pregnant or breastfeeding, think you may be pregnant or
are planning to have a baby.
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Things you should not do
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Do not stop treatment with this medicine suddenly.
Do not use contact lenses while receiving treatment with BLENREP unless instructed
by your eye care professional.
Do not breastfeed during treatment and for 3 months after your last dose of BLENREP.
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Driving or using machines
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BLENREP can cause problems with vision that can affect your ability to drive or use
machines. Do not drive or use machines unless you are sure your vision is not affected.
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Looking after your medicine
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BLENREP will be given to you in a hospital or clinic and the healthcare professionals
will be responsible for its storage.
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For more information, see Section 5. What should I know while being treated with BLENREP? in the full CMI.
This medicine can cause side effects, although not everybody gets them. Common side
effects include fever, fatigue, anaemia, nausea, diarrhoea, vomiting, cold or cold-like
symptoms, foamy or frothy urine, abnormal blood tests and abnormal levels of creatine
phosphokinase. Serious side effects include eye-related issues, abnormal bruising
or bleeding (thrombocytopenia), pneumonia, disorder of the blood vessels in the liver
and infusion-related reactions. 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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BLENREP can cause changes to the surface of your eye which can result in changes in
vision, blurred vision, and dry eyes. You should have an eye examination by an eye
care professional before each dose of BLENREP. Your doctor may request additional
eye tests while on treatment with BLENREP. If you have not had vision changes or other
eye changes, during the first six doses of BLENREP, your doctor may reduce eye exams
to approximately every three months with additional eye exams when needed. Even if
your vision seems fine, it is important that you get your eyes checked during treatment
with BLENREP because some changes can happen without symptoms and may only be seen
on an eye examination.
Tell your doctor if you notice changes with your vision. Your doctor may reduce the
dose or change the time between doses. Your doctor might also ask you to see an eye
care professional.
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BLENREP
Active ingredient(s):
Belantamab mafodotin
Consumer Medicine Information (CMI)
This leaflet provides important information about using BLENREP. 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 BLENREP.
Where to find information in this leaflet:
BLENREP contains the active ingredient belantamab mafodotin. Belantamab mafodotin is a monoclonal antibody connected to an anticancer medicine
that can kill multiple myeloma cells. The monoclonal antibody is a protein designed
to find the multiple myeloma cells in your body and bind to them. Once attached to
the cancer cells, the anticancer medicine is released and kills the cancer cells.
BLENREP is used to treat adults who have cancer of the bone marrow called multiple
myeloma.
BLENREP will be given to you together with other anticancer medicines used to treat
multiple myeloma:
bortezomib and dexamethasone, or
pomalidomide and dexamethasone.
Do not use BLENREP if:
you are allergic to belantamab mafodotin, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other conditions
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You must not breastfeed during treatment and for 3 months after your last dose of
BLENREP. It is not known if the medicine passes into breastmilk.
If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy
test before you start treatment with BLENREP. You must use effective contraception
during treatment and for 4 months after your last dose of BLENREP.
If you are a man who could father a child, you must use effective contraception during
treatment and for 6 months after your last dose of BLENREP.
Children and adolescents
This medicine is not intended for use in children or adolescents below 18 years of
age.
Eye-related issues
BLENREP can cause changes to the surface of your eye which can result in changes in
vision, blurred vision, and dry eyes.
You should have an eye examination by an eye care professional before each of the
first four doses of BLENREP.
Abnormal bruising and bleeding
BLENREP can decrease the number of blood cells called platelets which help to clot your blood.
Symptoms of low platelet counts (thrombocytopenia) include:
abnormal bruising under the skin,
bleeding longer than usual after a blood test or cut to the skin,
bleeding from your nose or your gums or more serious bleeding.
Your doctor will ask you to have a blood test before you start treatment, and regularly
during treatment with BLENREP, to check that your platelet levels are normal.
Infusion-related reactions
If you have previously had a reaction to an infusion of BLENREP or any other medicine,
tell your doctor or nurse before you receive another infusion.
Hepatitis B reactivation
Check with your doctor if you have a history of hepatitis B infection. Reactivation
of the hepatitis B virus can occur in patients treated with BLENREP.
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.
Some medicines may interfere with BLENREP and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BLENREP.
How much will be given
Your doctor will decide on the correct dose of BLENREP. The dose is calculated based
on your body weight.
BLENREP will be given together with other medicines used to treat multiple myeloma
in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
When BLENREP will be given
Your doctor will administer BLENREP as an intravenous infusion over approximately
30 minutes.
Your doctor will decide how many treatments you need.
If a dose of BLENREP is missed
BLENREP should be used regularly at the same time as scheduled by your doctor. It is very important that you do not miss a dose of this medicine, to make sure your
treatment works.
If you miss an appointment, make another one as soon as possible. Contact your doctor
or hospital as soon as possible to re-schedule your appointment.
If you are given more BLENREP than you should
As BLENREP is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much. If you think you have been given too much BLENREP
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.
You should do this even if there are no signs of discomfort or poisoning.
Things you should do
If you miss an appointment, contact your doctor or hospital immediately to reschedule.
Tell your doctor or nurse if you are taking, have or might take any other medicines.
Tell your doctor if you are pregnant, think you may be pregnant or are planning to
have a baby.
It is important to read the patient leaflets for the other anticancer medicines you
may be receiving. If you have any questions about these medicines, ask your doctor.
If you have previously had a reaction to an infusion of BLENREP, or any other medicine,
tell your doctor or nurse before you receive another infusion.
Apply lubricating and moistening eye drops (preservative-free artificial tears) before
your infusion. Use as instructed.
Continue to use the eye drops at least 4 times a day whilst you are receiving treatment
with BLENREP.
Call your doctor straight away if you:
think you may be having an allergic reaction.
experience blurred vision or other eye problems.
develop abnormal bleeding or bruising, or any symptoms that worry you.
develop any lung problems or any breathing-related symptoms that worry you.
Remind any doctor, nurse, dentist or pharmacist you visit that you are using BLENREP.
Things you should not do
Do not use contact lenses while you are receiving treatment unless instructed to do
so by your eye care professional.
Do not miss a dose of this medicine.
Do not breastfeed during treatment.
Eye-related issues
Your doctor may request further eye tests whilst on treatment with BLENREP.
Even if your vision seems fine, it is important that you get your eyes checked during
treatment with BLENREP because some changes can happen without symptoms and may only
be seen on an eye examination.
Inform your doctor if you notice changes with your vision. Your doctor may reduce
the dose or change the time between doses. Your doctor might also ask you to see an
eye care professional.
Some eye problems may feel uncomfortable or painful but tend to get better over time,
after your doctor changes your dose.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BLENREP
affects you.
BLENREP can cause problems with your vision that can affect your ability to drive
or use machines.
Do not drive or use machines unless you are sure your vision is not affected. Talk
to your doctor if you are not sure.
Looking after your medicine
BLENREP will be given to you in a hospital or clinic and the healthcare professionals
will be responsible for its storage.
Unopened vials:
Store in the original container.
Store in a refrigerator (2°C to 8°C).
Reconstituted solution:
The reconstituted solution can be stored for up to 4 hours at room temperature (20°C
to 25°C) or stored in a refrigerator (2°C to 8°C) for up to 4 hours.
Do not freeze.
Diluted solution:
If not used immediately, the diluted solution can be stored in a refrigerator (2°C
to 8°C) prior to administration for up to 24 hours.
Do not freeze.
The diluted infusion solution may be kept at room temperature (20°C to 25°C) for a
maximum of 6 hours (including infusion time).
When to discard your medicine (as relevant)
Your healthcare professional will be responsible for discarding BLENREP.
Getting rid of any unwanted medicine
Your healthcare professional will be responsible for discarding BLENREP.
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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General disorders:
fever,
general weakness
feeling tired (fatigue)
cold or cold-like symptoms such as cough, runny nose or sore throat (upper respiratory
tract infection)
Gastrointestinal disorders:
diarrhoea
nausea
constipation
vomiting
Renal and urinary disorders:
foamy, frothy, or bubbly-looking urine indicating a high level of protein in your
urine (albuminuria)
Urinary tract infection
Change in blood test results:
These may be found when your doctor tests for them.
abnormal levels of creatine phosphokinase
abnormal blood test indicating liver problems (aspartate aminotransferase, gamma glutamyltransferase,
alanine aminotransferase)
low number of red blood cells which carry oxygen in the blood (anaemia), causing weakness
and fatigue
low number of white blood cells in the blood which help to fight infections (lymphopenia,
leukopenia, neutropenia)
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Speak to your doctor if you have any of these less serious side effects or if 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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Eye disorders:
Eye-related issues, including:
changes to the surface of your eye
blurred vision
dry eyes
feeling of something in your eye (foreign body sensation in eyes)
eye irritation
decreased vision
sensitivity to light (photophobia)
eye pain
increased tear production (lacrimation)
double vision (diplopia)
discomfort in eye
eye sores, possibly with infection (infective keratitis and ulcerative keratitis)
itchy eyes (eye pruritus)
Gastrointestinal disorders:
diarrhoea (significant episodes)
Hepatobiliary disorders:
disorder of the blood vessels in the liver (porto-sinusoidal vascular disorder). This
can lead to abnormal liver blood tests and long-term problems such as increased pressure
of the blood vessels in the abdomen (portal hypertension), swelling of blood vessels
(varices), or a build-up of fluid in the abdomen which can cause abdominal pain, weight
gain or swelling of the abdomen (ascites).
Abnormal bruising or bleeding:
Low number of a type of blood cells called platelets which help to clot blood (thrombocytopenia),
which may be tested for by your doctor.
Lung problems (pneumonitis):
Severe and life-threatening inflammation of the lungs has occurred in some people
who received BLENREP. Possible symptoms of lung inflammation include:
shortness of breath
chest pain
new onset or worsening cough
Your doctor may decide to hold or stop treatment with BLENREP if you have these symptoms.
Infusion-related reactions:
BLENREP is given by a drip (infusion) into a vein. Some people who receive infusions
may develop allergic-like reactions when they receive an infusion. These usually develop
within minutes or hours but may develop up to 24 hours after treatment.
Symptoms include:
flushing
chills
fever
difficulty breathing
rapid heartbeat
drop in blood pressure
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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 nurse 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.
This medicine is only available with a doctor's prescription.
What BLENREP contains
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Active ingredient
(main ingredient)
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Belantamab mafodotin
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Other ingredients
(inactive ingredients)
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Sodium citrate dihydrate
Citric acid monohydrate
Trehalose dihydrate
Disodium edetate
Polysorbate 80
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Do not receive this medicine if you are allergic to any of these ingredients.
What BLENREP looks like
BLENREP is presented as a white to yellow powder in a glass vial with a rubber stopper
and a plastic removable cap. Each carton contains one vial.
One vial of powder contains 70 or 100 mg of belantamab mafodotin. After reconstitution
the solution contains 50 mg per mL belantamab mafodotin.
BLENREP 70 mg vials: AUST R 464326
BLENREP 100 mg vials: AUST R 464325
Who distributes BLENREP
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 033 109
Trademarks are owned by or licensed to the GSK group of companies.
© 2025 GSK group of companies or its licensor.
This leaflet was prepared on 22 October 2025.
Version 1.0
