25 mg, 100 mg, or 150 mg film-coated tablets
erlotinib
What Tarceva is and what it is used for
Tarceva contains the active substance erlotinib. Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells.
Tarceva is used in adults. This medicine may be prescribed to you if you have non-small cell lung cancer at an advanced stage. It may be prescribed as initial treatment or as treatment if your disease is largely unchanged after initial chemotherapy provided your cancer cells have specific EGFR mutations. It may also be prescribed if previous chemotherapy has failed to stop your disease.
This medicine may also be prescribed to you in combination with another treatment called gemcitabine if you have pancreatic cancer that has spread.
What you need to know before you take Tarceva
Take Tarceva
- if you are allergic to erlotinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- if you are taking other medicines that can increase or decrease the amount of erlotinib in your blood or affect the effect of erlotinib (eg antifungal medicines such as ketoconazole (except shampoo ), protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John’s wort or proteasome inhibitors), talk to your doctor. In some cases, these medicines may reduce the effectiveness or increase the side effects of Tarceva and your doctor may need to adjust your treatment. Your doctor may avoid treating you with these medicines during your Tarceva treatment.
- if you take anticoagulants (medicines that help prevent blood clots or blood clotting, eg warfarin ) Tarceva may increase your tendency to bleed. Talk to your doctor, he will regularly need to examine you with some blood tests.
- if you take statins (medicines that lower blood cholesterol levels), Tarceva may increase the risk of statin-related muscle problems, which in rare cases can lead to severe muscle breakdown ( rhabdomyolysis ) leading to kidney damage, talk to your doctor.
- if you use contact lenses and/or if you have previously had eye problems such as severe dry eyes, inflammation, or ulcers in the front part of the eye ( cornea ), you must tell your doctor.
See also below “Other medicines and Tarceva”.
You must inform your doctor:
- if you suddenly develop breathing difficulties associated with cough or fever as your doctor may need to treat you with other medicines and stop your Tarceva treatment;
- if you have diarrhea because your doctor may need to treat you with anti-diarrheal medicine (eg loperamide);
- immediately if you have severe or persistent diarrhea, nausea, loss of appetite, or vomiting as your doctor may need to stop your Tarceva treatment and you may need hospitalization;
- if you have severe abdominal pain, severe blisters, or skin peeling. Your doctor may need to interrupt or stop your treatment.
- if you develop acute or worsening redness and pain in the eye, increased tear flow, blurred vision, and/or sensitivity to light, contact your doctor or nurse immediately as you may need emergency care (see Possible side effects below).
- if you are also taking a statin and notice unexplained muscle pain, tenderness, weakness, or cramps. Your doctor may need to interrupt or stop your treatment.
See also section 4 “Potential side effects”.
Liver or kidney disease
It is not known whether Tarceva has a different effect if your liver or kidneys are not working normally. Treatment with this medicine is not recommended if you have severe liver disease or severe kidney disease.
Disorder of glucuronidation such as Gilbert’s disease
Tell your doctor if you have Gilbert’s disease or any other disorder of glucuronidation.
Smoking
You should stop smoking while being treated with Tarceva because smoking can reduce the amount of your medicine in your blood.
Children and adolescents
Tarceva has not been studied in patients younger than 18 years. Treatment with this medicine is not recommended for children and adolescents.
Other medicines and Tarceva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines
Tarceva with food and drink
Do not take Tarceva with food. See also section 3 “How to take Tarceva”.
Pregnancy and breastfeeding
Avoid becoming pregnant during your treatment with Tarceva. If you can become pregnant, use reliable methods of contraception during treatment, and for at least 2 weeks after taking the last tablet. If you become pregnant during your treatment with Tarceva, inform your doctor immediately who will decide whether treatment should be continued.
Do not breastfeed if you are being treated with Tarceva and for at least 2 weeks after taking the last tablet.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Tarceva has not been studied for its possible effects on the ability to drive or use machines, but your treatment is very unlikely to affect this ability.
Tarceva contains excipients
Tarceva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
Tarceva contains a sugar called lactose monohydrate.
If you have been told by your doctor that you have an intolerance to certain types of sugar, contact your doctor before taking Tarceva.
How to take Tarceva
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The tablet should be taken at least one hour before or two hours after food intake.
The usual dose is one tablet of Tarceva 150 mg every day if you have non-small cell lung cancer.
The usual dose is one Tarceva 100 mg tablet every day if you have spread pancreatic cancer. Tarceva is given together with gemcitabine therapy.
Your doctor may need to adjust your dose in steps of 50 mg at a time. For the different dosages, Tarceva is available in strengths of 25 mg, 100 mg, and 150 mg.
If you take more Tarceva than you should
Contact your doctor or pharmacist immediately.
You may experience increased side effects and your doctor may discontinue your treatment.
If you forget to take Tarceva
If you forget one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible. Do not take a double dose to make up for a missed dose.
If you stop taking Tarceva
It is important to continue taking Tarceva every day for as long as your doctor prescribes it for you.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact the doctor as soon as possible if you experience any of the following side effects. In some cases, your doctor may need to reduce your dose of Tarceva or stop treatment:
- Diarrhea or vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhea can lead to low levels of potassium in the blood and impair your kidney function, especially if you are receiving other chemotherapy at the same time. If you experience severe or persistent diarrhea, contact your doctor immediately as you may need hospital treatment.
- Eye irritation due to keratitis and/or conjunctivitis (very common: may affect more than 1 in 10 people) and keratitis ( corneal inflammation ) (common: may affect up to 1 in 10 people).
- A form of a lung disease called interstitial lung disease (less common in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 people in Japan). This disease can also be associated with the natural course of your medical condition and in some cases can be fatal. If you experience symptoms such as sudden breathing difficulties associated with cough and fever, contact your doctor immediately, as you may be suffering from this disease. Your doctor may decide to stop your treatment with Tarceva.
- Perforation of the gastrointestinal tract has been observed (uncommon: may affect up to 1 in 100 people). Tell your doctor if you have severe abdominal pain. Also tell the doctor if you have had peptic ulcers or diverticular disease in the past, as this may increase this risk.
- In rare cases, liver failure has been observed (rare: may affect up to 1 in 1,000 people). If your blood tests show serious changes in your liver function, your doctor may need to stop your treatment.
Very common side effects ( may affect more than 1 in 10 people):
- Skin rashes may appear or worsen on sun-exposed surfaces. If you are exposed to the sun, protective clothing and/or the use of sunscreen (eg, mineral-containing) may be appropriate.
- Infection
- Loss of appetite, weight loss
- Depression
- Headache, altered sensitivity of the skin, or numbness in the arms and legs
- Difficulty breathing, coughing
- Nausea
- Irritation in the mouth
- Stomach pain, upset stomach, tension
- Abnormal liver function values
- Itching, dry skin, and hair loss
- Fatigue, fever, chills
Common side effects ( may affect up to 1 in 10 people):
- Nosebleeds
- Bleeding from the stomach or intestines
- Inflammatory reactions around fingernails
- Inflammation in hair follicles
- Acne
- Skin cracks (skin fissures)
- Impaired renal function (when Tarceva is given outside the approved indication in combination with chemotherapy )
Uncommon side effects ( may affect up to 1 in 100 people):
- Changes in eyelashes ar
- Increased hair with a male pattern on the body and face
- Changes of eyebrows
- Brittle and loose nails
Rare side effects ( may affect up to 1 in 1,000 people):
- Reddened or painful palms or soles of the feet (hand-foot syndrome)
Very rare side effects ( may affect up to 1 in 10,000 people):
- Cases with ulceration or perforation of the cornea
- Severe blistering or peeling of the skin (may indicate Stevens-Johnson syndrome)
- Inflammation of the colored part of the eye
How to store Tarceva
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister and the outer carton after EXP and Ug.dat respectively. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance in Tarceva is erlotinib. Each film-coated tablet contains 25 mg, 100 mg, or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
- Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A, sodium lauryl sulfate, magnesium stearate (see also section 2 for lactose monohydrate ).
Tablet coating: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
Appearance and package sizes of the medicine
Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with “T 25” engraved on one side and is available in packs of 30 tablets.
Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with “T 100” engraved on one side and is available in packs of 30 tablets.
Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with “T 150” engraved on one side and is available in packs of 30 tablets.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
Finland/Finland
Roche Oy
Tel: +358 (0) 10 554 500