Posology : מינונים

4.2    Posology and method of administration

ERLOTINIB TARO treatment should be supervised by a physician experienced in the use of anti- cancer therapies.

Patients with Non-Small Cell Lung Cancer
EGFR mutation testing should be performed in accordance with the approved indications (see section 4.1).
The recommended daily dose of ERLOTINIB TARO 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 ERLOTINIB TARO is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the prescribing information of gemcitabine for thepancreatic cancer indication). In patients who do not develop rash within the first 4 - 8 weeks of treatment, further ERLOTINIB TARO 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).
ERLOTINIB TARO 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).

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 ERLOTINIB TARO to patients with hepatic impairment. Dose reduction or interruption of ERLOTINIB TARO 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 ERLOTINIB TARO in patients with severe hepatic dysfunction is not recommended (see section 5.2).

Ratients 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 section 5.2). Use of ERLOTINIB TARO in patients with severe renal impairment is not recommended.

Paediatric population
The safety and efficacy of erlotinib in the approved indications has not been established in patients under the age of 18 years. Use of ERLOTINIB TARO in paediatric patients is not recommended.

Smokers
Cigarette smoking has been shown to reduce erlotinib exposure by 50-60%. The maximum tolerated dose of ERLOTINIB TARO 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).