Erbitux 5 mg/mL Solution for infusion

Erbitux 5 mg/mL Solution for infusion is a brand of medicine containing the active ingredient cetuximab (rmc).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

ERBITUX®

cetuximab (rmc)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ERBITUX.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of treating you with ERBITUX against the benefits expected for you.

If you have any concerns about receiving this medicine, talk to your doctor, nurse or the hospital pharmacist.

Keep this leaflet while you are being treated with ERBITUX. You may need to read it again.

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What ERBITUX is used for

ERBITUX is used to treat certain cancers that have a protein on their cell surface called EGFR (epidermal growth factor receptor). When a growth factor called EGF attaches to 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.

How ERBITUX works

The active substance in ERBITUX is cetuximab. It belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are proteins that specifically recognise and attach to other unique proteins. ERBITUX attaches to the EGFR more tightly than EGF and thereby interferes with the growth of cancer cells.

What ERBITUX does

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 to treat metastatic colorectal cancer.

Before you are prescribed ERBITUX, your doctor will test your cancer cells to see if they contain either the normal (wild-type) or mutant forms of genes called RAS. ERBITUX is used to treat patients who express normal RAS genes.

ERBITUX is used to treat locally advanced head and neck cancer, in combination with radiation therapy. It is also used to treat head and neck cancer that has reoccurred or spread to other parts of the body in combination with certain types of chemotherapy.

Ask your doctor if you have any questions about why ERBITUX has been prescribed for you. Your doctor may have prescribed it for another use.

ERBITUX is available only with a doctor's prescription.

There is no evidence that ERBITUX is addictive.

Use in Children

The effectiveness of ERBITUX in children under the age of 18 years has not been established.

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Before starting treatment with ERBITUX

When you must not have it

Do not have ERBITUX if you experience severe hypersensitivity (allergic) reactions to cetuximab.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

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.

Do not have ERBITUX if you are allergic to any of the ingredients listed at the end of this leaflet.

Do not have ERBITUX in combination with anticancer treatments containing oxaliplatin if your cancer cells have been found to contain a mutant form of the RAS gene or if your RAS status is not known.

Ask your doctor if you have any questions about this.

If you receive ERBITUX in combination with chemotherapy medicines, ask your doctor or pharmacist for the Consumer Medicine Information for these medicines.

Do not have ERBITUX if the expiry date printed on the pack has passed. The nurse or hospital pharmacist will check the expiry date before giving ERBITUX to you.

Do not have ERBITUX if the packaging is torn or shows signs of tampering. The nurse will check this for you.

Check with your doctor or pharmacist if you are not sure about any of the above.

Before you start treatment with 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 weekly doses.

Your doctor may also prescribe some antibiotics (medicines used to treat infections) or apply hydrocortisone cream (a medicine used to treat inflammation) and/or moisturiser on your skin before you receive ERBITUX. This may help prevent or minimise skin reactions. He/she may also recommend you wear sunscreen.

Tell your doctor if you are pregnant or plan 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.

Tell your doctor if you are breastfeeding or wish to breastfeed during this time. You should not breastfeed during treatment and for 2 months after your last dose.

If it is necessary for you to have ERBITUX, your doctor will discuss the risks and benefits of having it if you are pregnant or breastfeeding.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

  • abnormal blood test results
  • liver problems
  • kidney problems
    This is because ERBITUX has been tested only in patients with adequate liver and kidney function, and in those without blood disorders.
  • 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
  • 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

Your doctor may want to take special care if you have any of the above conditions.

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell him/her before you start receiving ERBITUX.

Taking other medicines

Tell your doctor if you are taking any other medicines, including:

  • all prescription medicines
  • all medicines, vitamins, herbal supplements or natural therapies you buy without prescription from your pharmacy, supermarket, naturopath or health food shop.

Your doctor and pharmacist have more information on medicines to be careful with or to avoid while using ERBITUX.

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.

ERBITUX must not be mixed with any other injections. A separate infusion line must be used to give you any other injection.

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How to use ERBITUX

A doctor experienced in the use of medicines for cancer will supervise your treatment with ERBITUX. Trained nurses will administer ERBITUX to you.

ERBITUX is usually given once a week by intravenous infusion (slow injection into a vein).

ERBITUX may be administered either diluted or undiluted. Your doctor will determine the correct dose and dilution for you. 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.

How much to use

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 400 mg per square metre of body surface area and the infusion is given over a period of approximately 2 hours, with an infusion rate not faster than 5 mg/ min.

The following weekly doses of 250 mg per square metre of body surface area are infused over a period of approximately 1 hour, with an infusion rate not faster than 10 mg/ min.

How long to use ERBITUX for

Your doctor will decide how long you will receive ERBITUX based on your response to the medicine and the type of cancer you have.

If you miss a dose

If you miss a dose, talk to your doctor or nurse and arrange another visit as soon as possible.

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While you are being treated with ERBITUX

Things you must do

Keep all appointments with your doctor and always discuss anything that worries you during or after treatment with ERBITUX.

Before starting any new medicine, remind your doctor or pharmacist that you are receiving ERBITUX.

Tell all the doctors, dentists and pharmacists who are treating you that you are receiving ERBITUX.

If you become pregnant while you are treated with ERBITUX, tell your doctor immediately.

Things you must not do

Do not stop going to your visits for treatment with ERBITUX without checking with your doctor. Your condition may worsen if you stop receiving ERBITUX.

Things to be careful of

Be careful driving or operating machinery until you know how ERBITUX affects you. Treatment-related symptoms can affect your concentration and ability to react.

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Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are having ERBITUX. All medicines, including ERBITUX, can have unwanted side effects. Sometimes they are serious, most of the time they are not.

Most of the side effects occur during or soon after ERBITUX therapy. However, some may occur after this period.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Skin reactions

Tell your doctor if you notice any of the following symptoms of skin reaction and they worry you:

  • acne-like skin rash
  • itchy, dry, scaling skin
  • excessive growth of hair on your body
  • nail problems.

Skin reactions are very common. More than 8 in 10 people receiving ERBITUX may experience skin reactions.

Most of these side effects develop within the first three weeks of treatment. They usually disappear over time after the end of ERBITUX therapy.

Tell your doctor or nurse immediately if you experience:

  • severe blistering or peeling of the skin.
    These can be symptoms of a very rare (may affect less than 1 in 10,000 people) but severe skin reaction which may have serious consequences and can be life-threatening.
  • already affected areas of your skin getting worse, especially if you also experience general signs of infection such as fever and tiredness.
    These signs may indicate a skin infection, which may have serious consequences including life-threatening conditions.

Tell your doctor if you notice any other extensive skin rash.

Limit your exposure to sunlight by wearing a hat, protective clothing and sunscreen when you go outside.

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.

Your doctor may also prescribe some antibiotics, hydrocortisone cream and/or a moisturiser to help manage skin reactions.

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following:

  • red, watery eye(s) which can be accompanied by pain and blurring of your vision, eye sore, severe dry eye(s) or crusty eyelids
  • weakness, fatigue, loss of appetite, anorexia, vomiting or nausea (feeling sick). These symptoms may be due to low levels of magnesium, calcium or other electrolytes in your blood. Your doctor may do blood tests to check and may recommend electrolyte replacement
  • abdominal pain or diarrhoea
  • sore, red or dry mouth, which may be accompanied by a nose bleed
  • signs of frequent infections such as fever, tiredness, chills, sore throat or mouth ulcers
  • headache
  • leg swelling or pain (signs of a blood clot)
  • chest pain or tightness
  • sudden-onset fever, severe headache, vomiting, stiff neck and sensitivity to light.

Tell your doctor immediately if you experience sudden or worsened breathing difficulties, especially if you also experience cough or fever.

These can be symptoms of lung inflammation, which is rare (may affect less than 1 in 1,000 people) but can be life-threatening. Your treatment with ERBITUX may have to be interrupted or stopped altogether.

Ask your doctor to answer any questions you may have.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some patients.

Side effects in combination with chemotherapy or radiation therapy

If you receive ERBITUX in combination with chemotherapy medicines or radiation therapy, you may also experience some side effects from the chemotherapy medicine or the radiation therapy or from the combination of ERBITUX with these treatments.

Tell your doctor immediately if you experience:

  • signs of frequent infections such as fever, tiredness, chills, sore throat or mouth ulcers.
    If you receive ERBITUX in combination with chemotherapy including platinum, it is more likely that your white blood cell count may be reduced. You may experience the above symptoms and infectious complications which can include life-threatening conditions.
  • chest pain
  • redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel.
    If you receive ERBITUX in combination with chemotherapy containing fluoropyrimidines, it is more likely that you may experience some of the above symptoms.

Tell your doctor or nurse if you experience:

  • sore, red or dry mouth, which may be accompanied by a nose bleed
  • severe flaking or peeling of the skin
  • difficulty swallowing.
    If you receive ERBITUX in combination with radiation therapy, you may experience some of the above symptoms.

Tell your doctor if you experience any other side effects not listed in this leaflet.

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After being treated with ERBITUX

Storage

ERBITUX must be kept in a refrigerator at 2°C to 8°C, but it must not be frozen.

Each vial is intended for single use only. When the needed amount of solution has been withdrawn from the vial, any remaining solution must be discarded.

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Product description

What it looks like

ERBITUX is a clear, colourless 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.

Ingredients

The active ingredient in ERBITUX is cetuximab. Each 20 mL vial contains 100 mg cetuximab and each 100 mL vial contains 500 mg cetuximab.

The solution also contains the following inactive ingredients:

  • glycine
  • polysorbate 80
  • citric acid monohydrate
  • sodium chloride
  • water for injections
  • sodium hydroxide.

ERBITUX solution does not contain any preservative.

Supplier

ERBITUX is supplied in Australia by:
Merck Serono Australia Pty Ltd
3-4/25 Frenchs Forest Road East
Frenchs Forest NSW 2086

ERBITUX is supplied in New Zealand by:
Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Auckland

For enquiries about ERBITUX please call Merck Serono Australia Medical Information on 1800-MED-INF (1800-633-463) or from New Zealand call +61 2 8977 4100.

Australian Registration Numbers

AUST R 132393, 132396

Date of preparation

This leaflet was prepared in May 2015.

® Registered trademark

A011-0515

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CMI provided by MIMS Australia, October 2015  

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