Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.
Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.
Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumours (see section 5.1).
Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account (see sections 4.2 and 5.1).
No survival advantage could be shown for patients with locally advanced disease.
Tarceva treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
EGFR mutation testing should be performed in accordance with the approved indications (see section 4.1).
The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food.
The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication). In patients who do not develop rash within the first 4-8 weeks of treatment, further Tarceva treatment should be re-assessed (see section 5.1).
When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see section 4.4). Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see section 4.5).
Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment. Dose reduction or interruption of Tarceva should be considered if severe adverse reactions occur. The safety and efficacy of erlotinib has not been studied in patients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT >5 x ULN). Use of Tarceva in patients with severe hepatic dysfunction is not recommended (see section 5.2).
The safety and efficacy of erlotinib has not been studied in patients with renal impairment (serum creatinine concentration >1.5 times the upper normal limit). Based on pharmacokinetic data no dose adjustments appear necessary in patients with mild or moderate renal impairment (see section 5.2). Use of Tarceva in patients with severe renal impairment is not recommended.
The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years. Use of Tarceva in paediatric patients is not recommended.
Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%. The maximum tolerated dose of Tarceva in NSCLC patients who currently smoke cigarettes was 300 mg. The 300 mg dose did not show improved efficacy in second line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes. Safety data were comparable between the 300 mg and 150 mg doses; however, there was a numerical increase in the incidence of rash, interstitial lung disease and diarrhoea, in patients receiving the higher dose of erlotinib. Current smokers should be advised to stop smoking (see sections 4.4, 4.5, 5.1 and 5.2).
Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated. Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, severe adverse reactions such as diarrhoea, rash and possibly increased activity of liver aminotransferases may occur above the recommended dose.
In case of suspected overdose, Tarceva should be withheld and symptomatic treatment initiated.
Shelf life: 4 years.
This medicinal product does not require any special storage conditions.
PVC blister sealed with aluminium foil containing 30 tablets.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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