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.
1. Why am I using ERBITUX?
ERBITUX contains the active ingredient cetuximab. ERBITUX is used to treat metastatic
colorectal cancer, locally advanced head and neck cancer, and recurrent/metastatic
head and neck cancer.
2. What should I know before I use ERBITUX?
Do not use if your cancer cells have been found to contain a mutated form of the RAS
gene, if your RAS status is not known, or if you have ever had an allergic reaction
to ERBITUX 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 ERBITUX and affect how it works.
4. How do I use ERBITUX?
Before receiving the first dose, you should be given anti-allergy medicines (an antihistamine
and a corticosteroid) at least 1 hour prior to receiving ERBITUX.
The first dose is approximately 2 hours via infusion. The following doses are every
week (1 hour infusion period) or every 2 weeks (2 hours infusion period).
5. What should I know while using ERBITUX?
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist you visit that you are using ERBITUX.
Maintain adequate contraception during treatment and for two months after your last
dose.
Limit your exposure to sunlight. Wear a hat, protective clothing and sunscreen when
you go outside.
Keep all appointments with your doctor so that your progress can be checked.
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Driving or using machines
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Treatment-related symptoms can affect your concentration and ability to react. Be
careful until you know how ERBITUX affects you.
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6. Are there any side effects?
Common side effects include headache; conjunctivitis; diarrhoea; nausea; vomiting;
skin reactions; low magnesium/calcium levels in the blood; dehydration; loss of appetite,
leading to weight loss; infusion-related reactions; sore, red mouth (which may lead
to nosebleeds); tiredness; increased infections in combination with chemotherapy;
increased radiation-related effects in combination with radiotherapy; increased liver
enzyme levels.
Serious side effects include inflammation of the lining of the brain; blood clots;
lung inflammation; severe blistering or peeling of the skin; skin infections; heart
failure/attack; low white cell count.
Active ingredient(s):
cetuximab (rmc)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ERBITUX. 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 ERBITUX.
Where to find information in this leaflet:
1. Why am I using ERBITUX?
ERBITUX contains the active ingredient cetuximab. ERBITUX is a monoclonal antibody. Monoclonal antibodies are proteins that specifically
recognise and attach to other unique proteins.
When a growth factor called an epidermal growth factor (EGF) attaches to an epidermal
growth factor receptor (EGFR), it turns on signals within the cell causing it to grow
and divide to form more cells. In many human tumours, there is an over-activation
of these receptors, which leads to increased uncontrolled growth of cancer cells and
development into a tumour. ERBITUX attaches to the EGFR more tightly than EGF and
thereby interferes with the growth of cancer cells.
ERBITUX is used to treat:
Metastatic colorectal cancer (cancer of the colon or large intestine and rectum that
has spread to other parts of the body). It may be used alone or in combination with
certain types of medicines called chemotherapy.
Locally advanced head and neck cancer, in combination with radiation therapy.
Recurrent/metastatic head and neck cancer (cancer of the head and neck that has reoccurred
or spread to other parts of the body) in combination with certain types of chemotherapy.
2. What should I know before I use ERBITUX?
If you have metastatic colorectal cancer, your doctor will order tests to see if ERBITUX
is suitable for you. The test will check if your cancer cells contain either the normal
(wild-type) or mutated forms of genes called RAS. ERBITUX is used to treat patients
who express normal RAS genes.
Warnings
Do not use ERBITUX if:
You are allergic to cetuximab, or any of the ingredients listed at the end of this
leaflet. If you have had an allergic reaction to ERBITUX, your doctor will decide
whether or not you can receive it again. This will depend on the severity of your
reaction.
Always check the ingredients to make sure you can use this medicine.
If your cancer cells have been found to contain a mutated form of the RAS gene or
if your RAS status is not known (particularly, in combination with anticancer treatments
containing oxaliplatin).
Check with your doctor if you have any other medical conditions, including:
abnormal blood test results
liver problems
kidney problems
heart problems. If you have heart problems, your doctor will discuss with you whether
you can receive ERBITUX in combination with other anticancer medicines, especially
if you are 65 years of age or older.
lung problems or difficulty in breathing
acute or worsening eye problems such as blurred vision, eye pain, red eyes and/or
severe dry eye, or if you use contact lenses.
history of allergy to red meat, tick bites or to α-1-galactose
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.
ERBITUX is not recommended for use during pregnancy. Make sure you maintain adequate
contraception during treatment and for two months after your last dose.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
You should not breastfeed during treatment and for 2 months after your last dose.
If it is necessary for you to use ERBITUX, your doctor will discuss the risks and
benefits of having it if you are pregnant or breastfeeding.
Use in children
The effectiveness of ERBITUX in children under the age of 18 years has not been established.
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.
Some medicines may interfere with ERBITUX and affect how it works.
If your doctor is giving you other medicines, such as chemotherapy, with ERBITUX,
or is also treating you with radiation, he/she will discuss with you the benefits
and risks involved. If you receive ERBITUX in combination with chemotherapy medicines, ask your doctor
or pharmacist for the Consumer Medicine Information for these medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ERBITUX.
4. How do I use ERBITUX?
Before receiving the first dose, you should be given anti-allergy medicines (an antihistamine
and a corticosteroid) at least 1 hour prior to receiving ERBITUX to minimise the chances
of an allergic reaction. Pre-treatment with an antihistamine and a corticosteroid
is also recommended for the following doses.
Your doctor may also prescribe oral antibiotics or a topical steroid cream for your
skin before you are given ERBITUX. This may help prevent or minimise skin reactions.
How much to use
A doctor experienced in the use of medicines for cancer will supervise your treatment
with ERBITUX. Trained nurses will administer ERBITUX to you.
ERBITUX may be administered either diluted or undiluted. Your doctor will determine
the dilution for you.
Your doctor will calculate the correct dose of ERBITUX for you because it depends
on your body surface area (a measurement based on your height and weight).
The first dose is given over a period of approximately 2 hours via infusion.
The following doses are infused over a period of approximately 1 hour for weekly infusions
or 2 hours for every two week infusions.
Your doctor will decide how long you will receive ERBITUX based on your response to
the medicine and the type of cancer you have.
When to use ERBITUX
ERBITUX is either given once a week or once every two weeks by intravenous infusion
(slow injection into a vein).
If you are being treated with a chemotherapy medicine in combination with ERBITUX,
the chemotherapy medicine can only be started 1 hour after the end of the ERBITUX
infusion.
If you use too much ERBITUX
As ERBITUX is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much.
However, if you think that you have been given too much ERBITUX, 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.
5. What should I know while using ERBITUX?
Things you should do
Keep all appointments with your doctor so that your progress can be checked. Your
doctor may also conduct blood tests before starting ERBITUX and from time to time
during treatment. This is to make sure the medicine is working and to check for unwanted
side effects.
If you miss an appointment, call your healthcare provider to reschedule.
Limit your exposure to sunlight by wearing a hat, protective clothing and SPF 30+
or higher sunscreen when you go outside. Sun exposure may make your skin reactions
worse.
Call your doctor straight away if you:
become pregnant while you are treated with ERBITUX
Remind any doctor, nurse, dentist or pharmacist you visit that you are using ERBITUX.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ERBITUX
affects you.
Treatment-related symptoms can affect your concentration and ability to react.
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.
Tell your doctor or nurse as soon as possible if you do not feel well while you are
having ERBITUX.
Less serious side effects
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Less serious side effects
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What to do
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Infusion-related:
Fever, chills, shortness of breath, dizziness
To recognise early signs of these side effects, you will be monitored closely while
you are receiving each infusion and for at least 1 hour afterwards.
Your doctor may consider reducing the infusion rate of ERBITUX in order to manage
these symptoms.
Sometimes these side effects may occur up to several hours later.
If you experience them any time after receiving ERBITUX, contact your doctor or nurse.
Skin-related:
Acne-like rash
Itchy, dry, scaling skin
Excessive growth of hair on your body
Nail problems
These skin-related side effects can develop within the first three weeks of treatment.
They usually disappear over time after the end of ERBITUX therapy.
Other:
headache
red, watery eye(s) which can be accompanied by pain and blurring of your vision, eye
sore, severe dry eye(s) or crusty eyelids
abdominal pain or diarrhoea
weakness, fatigue, loss of appetite, weight loss, vomiting or nausea (feeling sick).
These symptoms may be due to low levels of magnesium, calcium, other electrolytes
or high levels of liver enzymes in your blood.
feeling dehydrated
sore, red or dry mouth, which may be accompanied by a nosebleed
signs of frequent infections such as fever, tiredness, chills, sore throat or mouth
ulcers
chest pain or tightness
sudden-onset fever, severe headache, vomiting, stiff neck and sensitivity to light.
In combination with radiation therapy:
sore, red or dry mouth, which may be accompanied by a nosebleed
severe flaking or peeling of the skin
difficulty swallowing
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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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Infusion-related:
Asthma-like symptoms such as severe breathing difficulties with wheezing, hoarseness,
hives and difficulty speaking.
A rapidly developing lumpy rash, chest pain, leg pain, feeling dizzy or faint.
Skin-related:
Severe blistering or peeling of the skin (Stevens-Johnson syndrome)
Already affected areas of your skin getting worse, especially if you also experience
general signs of infection such as fever and tiredness.
Tell your doctor if you notice any other extensive skin rash. Depending on how severe
your skin reaction is and how often it occurs, your doctor may:
stop ERBITUX for up to 2 weeks before giving you the next dose,
administer a lower dose, or
stop treatment altogether.
Other:
sudden or worsened breathing difficulties, especially with cough or fever (lung inflammation)
inflammation of the lining of the brain (aseptic meningitis)
leg swelling or pain (signs of a blood clot)
blood clots in the lungs
In combination with chemotherapy:
signs of frequent infections such as fever, tiredness, chills, sore throat or mouth
ulcers (reduced white blood cell count, which can lead to fever, pneumonia, and infection
in the blood).
chest pain (symptom of heart attack or heart failure)
redness and swelling of the palms of the hands or the soles of the feet which may
cause the skin to peel (hand-foot syndrome).
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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 ERBITUX contains
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Active ingredient
(main ingredient)
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Cetuximab (rmc)
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Other ingredients
(inactive ingredients)
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Glycine, polysorbate 80, citric acid monohydrate, sodium chloride, water for injections,
sodium hydroxide
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Potential allergens
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N/A
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Do not take this medicine if you are allergic to any of these ingredients.
What ERBITUX looks like
ERBITUX is a clear to slightly opalescent, colourless to yellowish solution. It is
supplied in 20 mL or 100 mL colourless glass vials with a rubber stopper and aluminium
seal. Each pack contains 1 vial. (Aust R 132393, 132396).
Who distributes ERBITUX
Merck Healthcare Pty Ltd
Suite 1, Level 1
Building B
11 Talavera Road
Macquarie Park NSW 2113
Medical Information: 1800 633 463
Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Auckland
Medical Information: 0800 426 252
This leaflet was prepared in November 2023.
Erbitux® is a trademark of ImClone LLC, used under license by Merck KGaA and its affiliates.