Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about Adcetris.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available. You should ensure that you
speak to your pharmacist or doctor to obtain the most up to date information on this
All medicines have risks and benefits. Your doctor has weighed the risks of you being
given this medicine against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Adcetris is used for
Adcetris contains the active ingredient brentuximab vedotin.
Adcetris belongs to a group of medicines known as anti-cancer agents. There are many
different classes of anti-cancer agents.
Adcetris is designed to work differently than traditional anti-cancer agents (chemotherapy).
Traditional chemotherapy enters the blood and kills both cancer cells and healthy
cells that divide rapidly. Adcetris is made up of a monoclonal antibody linked to
a substance intended to kill cancer cells. This substance is delivered to cancer cells
by the monoclonal antibody.
A monoclonal antibody is a protein which recognises certain cancer cells.
Adcetris is used to treat Hodgkin Lymphoma that has come back or not responded to
Adcetris may also be used alone to lower the likelihood of Hodgkin Lymphoma coming
back after a stem cell transplant in patients with certain risk factors. In these
patients, Adcetris may help prevent or delay recurrence of disease. Your doctor will
discuss the potential risks and benefits of receiving Adcetris following a stem cell
Hodgkin Lymphoma is a type of cancer of the white blood cells.
Adcetris is also used to treat patients with cutaneous T-Cell Lymphoma (CTCL) who
have previously received at least one anti-cancer medicine that travels through the
CTCL is a cancer of a certain type of white blood cell called a ‘T-cell’ that mainly
affects the skin. Adcetris is used to treat CTCL where a specific type of protein
is present on the cells’ surface.
Adcetris is also used to treat patients with peripheral T-Cell Lymphoma (PTCL) who
have not had treatment before.
PTCL is a type of non Hodgkin Lymphoma found in the lymph nodes and/or throughout
other parts of the body. When Adcetris is used to treat PTCL that has not already
been treated, it is given in combination with other chemotherapy medicines used to
treat this condition.
Systemic Anaplastic Large Cell Lymphoma (sALCL) is a type of PTCL. Adcetris may also
be used alone to treat sALCL that has come back or not responded to previous treatment.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed it for another purpose.
This medicine is available only with a doctor's prescription.
Before you are given Adcetris
When you must not be given it
Do not receive Adcetris if you have an allergy to:
any medicine containing brentuximab vedotin
any of the ingredients listed at the end of this leaflet
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue, which may cause difficulty in swallowing
Do not receive Adcetris if you are currently taking a medicine called bleomycin, an
If you are not sure if you should start receiving Adcetris, talk to your doctor.
Before you are given it
Tell your doctor if you have any allergies to any other medicines, foods, preservatives
Tell your doctor if you have, or think you have, an infection.
Tell your doctor if you are taking, or have previously taken, medicines which may
affect your immune system, such as chemotherapy or immunosuppressive agents.
If you are taking or have taken medicines which affect your immune system, you may
have an increased risk of infections.
Tell your doctor if you have or have had any of the following medical conditions:
Tell your doctor if you are intending to get pregnant or father a child. You and your
partner must use two methods of effective contraception during your treatment with
Women must continue using contraception for 6 months following the last dose of Adcetris.
Men being treated with Adcetris are advised to have sperm samples frozen and stored
before treatment. Men are advised not to father a child during treatment with this
medicine and for up to 6 months following the last dose of this medicine.
Tell your doctor if you are pregnant, think you may be pregnant or are breastfeeding.
Your doctor can discuss the risks and benefits involved.
If you have not told your doctor or pharmacist about any of the above, tell them before
you are given Adcetris.
The safety of Adcetris beyond 12 months of treatment has not been established.
Use in children
The safety and effectiveness of Adcetris has not been established in children.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you buy without a prescription from your pharmacy, supermarket or health food
Some medicines and Adcetris may interfere with each other. These include:
medicines used in the treatment of fungal infections such as ketoconazole or itraconazole
These medicines may be affected by Adcetris, or may affect how well it works. You
may need to use different amounts of your medicine, or take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while receiving Adcetris.
How Adcetris is given
Adcetris is given by an infusion into a vein (intravenous infusion) over 30 minutes
by a healthcare professional. You will be monitored during and after the infusion.
Your doctor will decide what dose and how long you will receive Adcetris .
The dose of Adcetris depends on your body weight.
The usual recommended dose of Adcetris when it is given alone is 1.8 mg/kg, given
once every 3 weeks. Your doctor may lower your starting dose to 1.2 mg/kg if you have
kidney or liver problems.
If you are a patient with PTCL that has not already been treated, you will receive
Adcetris in combination with cyclophosphamide, doxorubicin, and prednisone which are
other medicines used to treat this condition. See the Consumer Medicine Information
leaflets for these medicines given in combination with Adcetris for additional information
on their use and effects.
The usual dose of Adcetris given in combination with cyclophosphamide, doxorubicin,
and prednisone is 1.8 mg/kg given every 3 weeks for approximately 4 - 6 months. Your
doctor may lower your starting dose to 0.9 mg/kg if you have mild liver problems.
Adcetris is to be given to adults only. It is not for use in children.
As Adcetris is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much. However, if you experience any side effects after
being given Adcetris, tell your doctor immediately.
While you are receiving Adcetris
Things you must do
If you are of child bearing potential, you and your partner should use two methods
of effective contraception during treatment with Adcetris.
If you become pregnant while you are receiving this medicine, tell your doctor or
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are receiving Adcetris.
Tell any other doctors, dentists and pharmacists who treat you that you are receiving
If you are going to have surgery, tell the surgeon that you are receiving this medicine.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do regular blood tests to make sure it is safe for you to receive
this medicine and to help prevent unwanted side-effects.
Some patients receiving Adcetris may develop some serious conditions requiring immediate
Tell your doctor straight away if you notice any of the following symptoms because
some of them may be signs of a serious or possibly fatal condition.
Progressive multifocal leukoencephalopathy (PML)
PML is a serious and life-threatening brain condition.
Tell your partner or caregiver you are receiving Adcetris and ask them to tell you
if they notice any changes in your movement or behaviour. Symptoms of PML can include:
confusion or trouble thinking clearly
blurred vision or loss of vision
decreased strength/control or sensation in your arms or legs, a change in the way
you walk or problems with your balance
Tell your doctor straight away if you develop new or worsening shortness of breath
These could be symptoms of a side-effect called pulmonary toxicity.
Tell your doctor straight away if you develop a loss of appetite, pain in the upper
right side of your stomach area, nausea, vomiting, yellowing of your skin or the white
part of your eyes (jaundice).
These could be symptoms of a side-effect called hepatotoxicity.
Inflammation of the pancreas
Tell your doctor straight away if you get any of the following symptoms:
stomach pain with or without nausea and vomiting
These could be symptoms of a condition called pancreatitis.
Tell your doctor right away if you get any of the following symptoms:
fever (greater than or equal to 38°C) and/or chills or shivering
pain on urination
These could be symptoms of an infection and/or caused by a condition called febrile
neutropenia (lack of white blood cells).
Medicines of this type (monoclonal antibodies) can cause infusion reactions. In general,
these types of reactions occur within minutes to several hours following completion
of the infusion. However, they may develop more than several hours after completion
of the infusion but this is uncommon. Symptoms of infusion reactions include:
rash, shortness of breath, difficulty breathing or a tight chest, fever and back pain.
If you think you have previously had a similar reaction, tell your doctor before you
are given this medicine.
Severe Skin Reactions
Tell your doctor right away if you experience flu-like symptoms followed by a painful
red or purplish rash that spreads and blisters.
These could be symptoms of rare, serious disorders called Stevens-Johnson syndrome
and Toxic Epidermal Necrolysis.
Gastrointestinal (bowel) problems
Tell your doctor straight away if you get any of the following symptoms:
severe stomach pain,
nausea, vomiting or diarrhoea
Other serious side-effects
Tell your doctor right away if you get any of the following symptoms:
a potentially-life threatening condition called tumour lysis syndrome in which you
may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling,
shortness of breath, or heart rhythm disturbances
a condition called peripheral neuropathy which can change the sensitivity of the skin,
causing symptoms such as numbness, tingling, discomfort, a burning sensation, weakness,
or pain in the hands or feet
a condition called motor neuropathy, which can cause symptoms that include a feeling
of weakness and difficulty walking
The above list includes very serious side effects. You may need urgent medical attention.
Many of these side effects are rare.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are receiving Adcetris.
All medicines have some unwanted side effects. Sometimes they are serious, but most
of the time they are not. You may need medical attention if you get some of the side-effects.
Do not be alarmed by this list of possible side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
See the 'While you are receiving Adcetris' section above for a list of serious side
effects which you must be particularly aware of. Tell your doctor immediately if you
notice any of the symptoms listed above.
The following is a list of other symptoms and conditions that can occur:
upper respiratory tract infection
pneumonia, a type of lung infection
feeling tired, frequent urination, increased thirst, changes in your appetite with
unintended weight loss, and irritability, these could be symptoms of a condition called
hyperglycaemia (high blood sugar)
unusual bleeding or bruising under the skin or bleeding from your gums, symptoms of
a condition called thrombocytopenia caused by low levels of platelets in your blood
headaches, experience dizziness, look pale, may be caused by a condition called anaemia
(decreased number of red blood cells)
unusual hair loss or thinning
joint pain or painful, swollen joints
blisters which may crust or scab
skin redness, pain, swelling, blistering or peeling at the infusion site
increased liver enzyme levels (something that your doctor will measure for you)
new or recurring cytomegalovirus (CMV) infection
sore, creamy-yellow, raised patches in the mouth (thrush)
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
severe skin rash, itching, hives
swelling of the face, lips, mouth or throat which may cause difficulty in swallowing
Tell your doctor or pharmacist if you notice anything else that is making you feel
Other side effects not listed above may occur in some people.
After using Adcetris
Keep the unopened vial in a refrigerator stored between 2-8 degrees C. Do not freeze.
Keep the vial in the original carton in order to protect from light.
Keep it where children cannot reach it.
If your doctor or pharmacist tells you to stop taking this medicine, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that are left
What it looks like
Adcetris is a white to off-white cake or powder provided in a glass vial.
Each pack of Adcetris consists of one vial.
Adcetris contains 50 mg of brentuximab vedotin as the active ingredient:
It also contains
citric acid monohydrate
sodium citrate dihydrate
Adcetris does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.
Adcetris is supplied in Australia by:
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Ph: 1800 012 612
ADCETRIS® is a registered trade mark of Millennium Pharmaceuticals, Inc., a Takeda
This leaflet was prepared May 2021
Australian Registration Number(s)
AUST R 203372