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.
1. Why am I being given Epkinly?
Epkinly contains the active ingredient epcoritamab. Epkinly is used to treat diffuse
large B-cell lymphoma (DLBCL).
2. What should I know before I am given Epkinly?
Do not use if you have ever had an allergic reaction to epcoritamab 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.
3. What if I am taking other medicines?
Some medicines may interfere with Epkinly and affect how it works.
4. How is Epkinly given?
You will receive Epkinly as an injection under your skin on a dosing schedule given
to you by your healthcare professional.
5. What should I know while being given Epkinly?
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Things you should do
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Remind any doctor, nurse, dentist, pharmacist or any other health care professionals
you visit that you are using Epkinly.
Keep all your appointments relating to your treatment, including any blood tests.
Call your doctor straight away if you experience symptoms of cytokine release syndrome
(CRS), haemophagocytic lymphohistiocytosis (HLH), immune effector cell-associated
neurotoxicity syndrome (ICANS), or serious infection as listed in Section 6.
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Things you should not do
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Do not stop your Epkinly treatment without checking with your doctor.
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Driving or using machines
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Take care when driving or using machinery until you know how Epkinly affects you.
If you feel any symptoms that may affect your ability to drive, do not drive, or use
machines until the symptoms stops.
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6. Are there any side effects?
The more serious side effects can include cytokine release syndrome (CRS) and immune
effector cell-associated neurotoxicity syndrome (ICANS).
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 .
Active ingredient:
epcoritamab (ep-kor-ri-ta-mab)
This medicine has provisional registration in Australia for the treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. EPKINLY
is not indicated for the treatment of patients with primary central nervous system
lymphoma. The decision to provisionally register this medicine has been made on the
basis of promising results from preliminary studies. More evidence is required to
be submitted when available to substantiate the benefit of the medicine for this use.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Epkinly. 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 Epkinly.
Your doctor will give you a Patient Card. Read it carefully and follow the instructions
on it. Keep this Patient Card with you at all times. Always show the Patient Card
to the doctor or nurse when you see them or if you go to hospital.
Where to find information in this leaflet:
1. Why am I being given Epkinly?
Epkinly contains the active ingredient epcoritamab.
Epcoritamab is a bispecific antibody that was specifically designed to enable your
immune system to attack lymphoma cells.
Epkinly is used to treat diffuse large B-cell lymphoma (DLBCL).
2. What should I know before I am given Epkinly?
Warnings
Do not use Epkinly if:
you are allergic to epcoritamab, 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 current or past problems with your nervous system – such as seizures
have an infection
are due to have a vaccine or you know you may need to have one in the near future
are pregnant or plan to become pregnant
take any medicines for any other condition.
Epkinly can cause serious side effects that can be severe or, life-threatening and
can lead to death.
These side effects include cytokine release syndrome (CRS), haemophagocytic lymphohistiocytosis
(HLH), immune effector cell-associated neurotoxicity syndrome (ICANS) and serious
infection. See Section
6. Are there any side effects? for the symptoms of these side effects.
Tell your doctor straight away if you get symptoms of any of the side effects listed
below, during or after treatment with Epkinly. You may need additional medical treatment.
Cytokine Release Syndrome (CRS)
A condition associated with medicines that stimulate T cells (a type of white blood
cells). Before each injection under the skin, you may be given additional medicines,
which help reduce possible side effects of CRS.
Haemophagocytic lymphohistiocytosis (HLH)
A condition that is characterised by overactivity of the immune system.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Effects on your nervous system which can occur days or weeks after you receive the
injection and may initially be subtle. Some of these symptoms may be signs of a serious
immune reaction called ICANS.
Serious Infection
You may get signs of infection, which can vary depending on where in the body the
infection is. It can occur at any time, either during treatment or several months
after treatment ends.
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. Pregnancy
must be ruled out before treatment. There is no information about the safety of Epkinly
in pregnant women. Tell your doctor immediately if you become pregnant.
If you are a woman of child-bearing potential, use of effective contraception during
treatment with Epkinly and for at least 4 months after the last dose of Epkinly. Talk
to your doctor or nurse about suitable methods of contraception.
Talk to your doctor if you are breastfeeding or intend to breastfeed. You must not
breastfeed during treatment with Epkinly and for at least 4 months after the last
dose. It is not known whether Epkinly passes into breastmilk and could therefore affect
the baby.
Fertility
The effect of epcoritamab on male and female fertility is unknown.
3. What if I am taking other medicines?
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.
4. How is Epkinly given?
How Epkinly is administered
Epkinly will be given to you by a doctor or nurse and it will be given as an injection
under your skin.
Epkinly will be given to you in cycles of 28 days, on a dosing schedule selected by
your doctor. Follow the treatment schedule explained to you by your doctor.
You will usually be given Epkinly according to the following schedule:
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Cycle
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Dosing Schedule
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Cycle 1 to 3
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Weekly
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Cycles 4 to 9
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Every other week
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Cycles 10 and beyond
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Every four weeks
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You may be given other medicines before you are given Epkinly. This is to help prevent
side effects of treatment.
The first full dose (48 mg) of Epkinly will be given to you on Cycle 1 Day 15. Stay
within close proximity to a healthcare facility for at least 24 hours after the first
full dose (48 mg).
You will be given Epkinly for as long as your doctor thinks you are benefitting from
the treatment.
Your doctor may delay or completely stop your treatment with Epkinly if you have certain
side effects.
If you miss your Epkinly dose
If you miss your medical appointment for treatment, immediately contact your healthcare
professional to discuss rescheduling. For the treatment to be fully effective it is
very important not to miss a dose.
If you use too much Epkinly
As Epkinly is given to you by your healthcare professional, it is unlikely that you
will be given too much. However, if you experience any side effects after being given
Epkinly, tell your doctor or nurse immediately.
5. What should I know while being given Epkinly?
Things you should do
Call your doctor straight away if you:
Remind any doctor, dentist, pharmacist or nurse you visit that you are using Epkinly.
Things you should not do
Do not stop using this medicine without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Epkinly
affects you.
Due to the potential risk of ICANS, you should be careful while driving or using heavy
or potentially dangerous machines. If you are currently having such symptoms, avoid
these activities and contact your health care professional.
Looking after your medicine
Epkinly will be stored by your healthcare professional in the pharmacy or on the hospital
ward in a refrigerator at a temperature between 2°C to 8°C.
When to discard your medicine
Your healthcare professional will throw away any unused medicine following 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, pharmacist or nurse
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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diarrhoea
fever due to infection when you have low levels of white blood cells (febrile neutropenia)
headache
injection site reactions
itching
nausea
pneumonia (lung infection)
rash
tender swollen lymph nodes, chest pain, cough or difficulty breathing, pain at the
site of the tumour (tumour flare)
tumour lysis syndrome (a rapid breakdown of tumour cells resulting in chemical changes
in the blood and damage to organs, including the kidneys, heart and liver)
upper respiratory tract infections (infection of the airways)
vomiting.
Shown in blood tests:
low levels of some white blood cells, which can cause infections (neutropenia)
low number of red blood cells, which can cause tiredness (anaemia)
low platelet count, which may make you more likely to bruise or bleed (thrombocytopenia).
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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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Symptoms of Cytokine Release Syndrome (CRS):
fever
dizziness/light-headedness
chills
fast heartbeat
difficulty breathing/shortness of breath
headache.
Symptoms of haemophagocytic lymphohistiocytosis (HLH):
fever
low blood cell counts
bruising (dark mark on the skin) more easily
liver problems
Symptoms of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS):
difficulty speaking or writing
drowsiness
confusion/disorientation
muscle weakness
seizures
memory loss.
Symptoms of serious infection:
fever of 38°C or above
chills
cough
chest pain
shortness of breath
painful rash
sore throat
pain with urination
feeling weak or generally unwell
confusion.
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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 Epkinly contains
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Active ingredient
(main ingredient)
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epcoritamab
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Other ingredients
(inactive ingredients)
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sodium acetate trihydrate
glacial acetic acid
sorbitol
polysorbate 80
water for injections
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Potential allergens
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The vial stopper is NOT made with natural rubber latex.
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Do not take this medicine if you are allergic to any of these ingredients.
What Epkinly looks like
Epkinly is a sterile preservative free, clear to slightly opalescent, colourless to
slightly yellow solution, practically free of visible particles.
Epkinly is supplied in a pack size of 1 single-dose vial containing:
4 mg/0.8 mL concentrate solution for injection (AUST R 404978)
48 mg/0.8 mL solution for injection (AUST R 404977)
Who distributes Epkinly
EPKINLY is distributed in Australia by:
AbbVie Pty Ltd
241 O'Riordan Street
Mascot NSW 2020
Australia
This leaflet was prepared in March 2025.
Version 2
© 2025 AbbVie. All rights reserved.
EPKINLY® is a registered trademark of AbbVie Biotechnology Ltd.