How does it work?

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

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

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

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

Tarceva tablets are taken by mouth once a day with a glass ofwater. They should be taken on an empty stomach, at least one hour before ortwo 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 aclinical 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.
• Women who could get pregnant should use a reliable method of contraception to avoid pregnancy while taking this medicine and for at least two weeks after treatment is finished. Seek further medical advice from your doctor.
• 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.
• You should also tell your doctor straight away if you experience any severe pain in your abdomen, severe blistering or peeling of your skin, or any sudden orworsening eye problems (for example eye pain). Your doctor may need to interrupt or stop yourtreatment.
• This medicine may on rare occasions cause liver problems. If you have any existing 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.

Use with caution in

• Decreased liver function or liver disease.
• People with a glucuronidation disorder like Gilbert’ssyndrome.
• People with a history of peptic ulcer or diverticular disease.
• People also being treated with anti-angiogenic agents,corticosteroids, NSAIDs, and/or taxane based chemotherapy (see end of this page for examples).

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 orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, 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.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Very common (affect more than 1 in 10 people)

• Rash.
• Diarrhoea. See warning section above. Persistent andsevere diarrhoea may lead to dehydration, low blood potassium and kidney failure, particularly if you receive otherchemotherapy treatments at the same time.
• Fatigue.
• Itching.
• Dry skin.
• Infection.
• Loss of appetite.
• Weight loss.
• Shortness of breath.
• Cough.
• Nausea and vomiting.
• Abdominal pain.
• Indigestion.
• Wind (flatulence).
• Inflammation of the lining of the mouth.
• Eye irritation due to conjunctivitis/keratoconjunctivitis.
• Depression.
• Headache.
• Altered sensation, such as tingling or numbness.
• Hair loss.
• Fever.

Common (affect between 1 in 10 and 1 in 100 people)

• Nosebleeds.
• Bleeding from the stomach or intestines. Tell your doctor if you notice blood in your stools or tarry/black stools while taking this medicine.
• Inflammation around the nails.
• Abnormal liver function.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Perforation of the gut. Tell your doctor straight away if you get any severe abdominal pain during treatment.
• Increased hair growth (hirsutism).
• Eyelash and eyebrow changes.
• Brittle and loose nails.
• Mild skin reactions, such as increased skin pigmentation.
• A form of lung irritation called interstitial lung disease (see warning section above).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Liver failure.

Very rare (affect less than 1 in 10,000 people)

• Severe blistering or peeling skin reactions, eg Steven's Johnson syndrome or toxic epidermal necrolysis.
• Ulceration or perforation of the cornea.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to make sure that thecombination is safe.

The following medicines may decrease the breakdown of erlotinibby the body and so could increase the amount of erlotinib in theblood. This may increase the risk of side effects and for this reason, these medicinesshould be avoided where possible while you are having treatment with thismedicine:

• azole antifungals, eg ketoconazole, itraconazole, voriconazole
• capecitabine
• ciprofloxacin
• fluvoxamine
• protease inhibitors for HIV infection, eg ritonavir
• the antibiotics erythromycin or clarithromycin.

If you are prescribed any of the above medicines while you aretaking erlotinib, you should let your doctor know if you get any new orincreased side effects. Your doctor may need to decrease your dose oferlotinib.

The following medicines may increase the breakdown of erlotinibby the body and so could decrease the amount of erlotinib in the blood. As these medicines could make erlotinib less effective theyshould be avoided where possible while you are having treatment with thismedicine:

• barbiturates, eg phenobarbital, amobarbital
• carbamazepine
• phenytoin
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

The following medicines used to reduce the acidity in the stomach may reduce the absorption of erlotinibfrom the gut. As they could make the erlotinib less effective, these medicines should be avoided where possible during your treatment:

• antacids for indigestion or heartburn
• H2 antagonists, eg cimetidine, ranitidine
• proton pump inhibitors, eg omeprazole, lansoprazole.

If a medicine for reducing stomach acid is essential during your treatment with erlotinib, an antacid is the preferred option. In this case it should be taken at least four hours before or two hours after your daily dose of erlotinib. If ranitidine is considered necessary it should be taken at least ten hours before or two hours after your daily dose of erlotinib.

Erlotinib may increase the anti-blood-clotting effect ofanticoagulant medicines such as warfarin, which could increase the risk of bleeding. If you are taking an anticoagulant incombination with erlotinib, your blood clotting time (INR) should be monitoredmore frequently.

There may also be an increased risk of bleeding, particularly in thegut, if non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,ibuprofen, diclofenac or naproxen are taken in combination with thismedicine.

There may be an increased risk of perforation (holes appearing) in the gut if any of the following medicines are used in combination with this one:

• anti-angiogenic agents, eg lenalidomide, thalidomide, sorafenib, sunitinib
• corticosteroids, eg dexamethasone, prednisolone
• NSAIDs, eg aspirin,ibuprofen, diclofenac, naproxen
• taxane based chemotherapy, eg paclitaxel, docetaxel.

The following medicines should be used with caution incombination with erlotinib because they may affect its action:

• ciclosporin
• verapamil.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain erlotinib as the active ingredient.