Tarceva (erlotinib)

How does it work?

Tarceva tablets contain the active ingredient erlotinib, which is a type of medicine called a tyrosine kinase inhibitor. It works by interfering with the pathways that signal certain cancer cells to grow.

Many cancer cells have structures called epidermal growth factor receptors (EGFRs) on their surfaces. These receptors allow a protein called epidermal growth factor (EGF) to attach to the cells. When the epidermal growth factor attaches to the receptor, it activates an enzyme in the cell called tyrosine kinase. This enzyme triggers chemical processes inside the cancer cells that make the cells grow and multiply.

Erlotinib works by attaching to the tyrosine kinase enzyme. This stops the epidermal growth factor from activating it and, as a result, stops the cancer cells from growing and multiplying.

Your doctor may do various tests to check the level of EGFR on your cancer cells, as this can predict if your cancer is likely to respond to the treatment.

Tarceva tablets are taken by mouth once a day with a glass of water. They should be taken on an empty stomach, at least one hour before or two hours after any food.

What is it used for?

Non-small cell lung cancer that is locally advanced, or has spread to other areas of the body. (This medicine may be used after at least one regimen of chemotherapy has been unsuccessful at treating the cancer.)

Pancreatic cancer that has spread to other areas of the body. (This medicine is used in combination with a medicine called gemcitabine to treat cancer of the pancreas.)

Other unlicensed uses of this medicine should be as part of a clinical trial.

Warning!

It is very important that if you smoke, you stop smoking while you are receiving treatment with this medicine. This is not only because smoking causes cancer and may make your condition worse, but also because smoking decreases the amount of this medicine in the blood and could make it less effective at treating your cancer. If you smoke, ask your doctor or pharmacist for advice on how to give up.

Approximately 50 per cent of people treated with this medicine get diarrhoea as a side effect. This is usually mild. You should let your doctor know if you get diarrhoea, as you may need a medicine to control it, for example loperamide. Your dose of erlotinib may also need reducing. If you do get diarrhoea during treatment, it is important to drink plenty of fluids so that you don't get dehydrated. If you have severe or persistent diarrhoea, nausea, loss of appetite, or vomiting you should let your doctor know immediately, as your treatment may need interrupting and you may need to be treated in hospital.

If you get a sudden new or worsening cough, high temperature (fever), wheezing or shortness of breath while taking this medicine, you should let your doctor know, as these could be symptoms of a rare form of lung irritation called interstitial lung disease, which can be a side effect of this medicine.

This medicine may on rare occasions cause liver problems. If you have any problems with your liver, or are taking other medicines that could affect your liver, your doctor may want you to have regular blood tests to monitor your liver function while you are having treatment with this medicine.

Women who could get pregnant should use a reliable method of contraception to avoid getting pregnant while taking this medicine and for at least two weeks after treatment is finished. Seek further medical advice from your doctor.

Use with caution in

Decreased liver function.

Not to be used in

Allergy to any ingredient.

Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Tarceva tablets contain lactose).

This medicine is not recommended for people with severely decreased kidney or liver function.

This medicine is not recommended for children and adolescents under 18 years of age.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine in pregnancy has not been established. It is likely to be harmful to a developing baby. For this reason, it should not be used during pregnancy unless considered essential by your doctor, and only if the potential benefit to the mother outweighs any risks to the developing baby. Women who could get pregnant should use a reliable method of contraception to avoid getting pregnant while taking this medicine and for at least two weeks after treatment is finished. Seek further medical advice from your doctor.

It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should bottlefeed rather than breastfeed, because if the medicine does pass into the breast milk it could be harmful to a nursing infant. Seek medical advice from your doctor.

Label warnings

This medicine should be taken on an empty stomach, at least one hour before or two hours after food.

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