ALVOCEVA treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Posology: Patients with Non-Small Cell Lung Cancer: EGFR mutation testing should be performed prior to initiation of ALVOCEVA therapy in chemo-naïve patients with advanced or metastatic NSCLC.
The recommended daily dose of ALVOCEVA is 150 mg taken at least one hour before or two hours after the ingestion of food.
Patients with pancreatic cancer: The recommended daily dose of ALVOCEVA 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 ALVOCEVA treatment should be re-assessed (see Pharmacology: Pharmacodynamics under Actions).
When dose adjustment is necessary, the dose should be reduced in 50 mg steps (see Precautions).
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see Interactions).
Patients with hepatic impairment: 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 ALVOCEVA to patients with hepatic impairment. Dose reduction or interruption of ALVOCEVA 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 ALVOCEVA in patients with severe hepatic dysfunction is not recommended (see Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: 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 Pharmacology: Pharmacokinetics under Actions). Use of ALVOCEVA in patients with severe renal impairment is not recommended.
Paediatric population: The safety and efficacy of erlotinib in patients under the age of 18 years has not been established. Use of ALVOCEVA in paediatric patients is not recommended.
Smokers: Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%. The maximum tolerated dose of ALVOCEVA in NSCLC patients who currently smoke cigarettes was 300 mg. Efficacy and long term safety of a dose higher than the recommended starting doses have not been established in patients who continue to smoke cigarettes (see Interactions and Pharmacology: Pharmacokinetics under Actions). Therefore, current smokers should be advised to stop smoking, as plasma concentrations of erlotinib in smokers as compared to non-smokers are reduced.