Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
Erlotinib is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.
Erlotinib 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.
Erlotinib 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, erlotinib is indicated when other treatment options are not considered suitable.
When prescribing erlotinib, 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 .
Pancreatic cancer
Erlotinib in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.
When prescribing erlotinib, factors associated with prolonged survival should be taken into account.
No survival advantage could be shown for patients with locally advanced disease. POSOLOGY AND METHOD OF ADMINISTRATION
Erlotinib treatment should be supervised by a physician experienced in the use of anti- cancer therapies.
Patients with Non-Small Cell Lung Cancer:
It is recommended to perform EGFR mutation testing before starting treatment with erlotinib in patients with advanced or metastatic NSCLC who have not previously undergone chemotherapy.
The recommended daily dose of erlotinib 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 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 erlotinib treatment should be re-assessed.
When dose adjustment is necessary, the dose should be reduced in 50 mg steps.
Concomitant use of CYP3A4 substrates and modulators may require dose adjustment.
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 to patients with hepatic impairment. Dose reduction or interruption of erlotinib 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 in patients with severe hepatic dysfunction is not recommended.
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. Use of erlotinib 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 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 in NSCLC patients who currently smoke cigarettes was 300 mg. The long-term efficacy and safety at doses higher than the recommended dose when starting treatment have not been established in patients who continue to smoke. Therefore, it is recommended that patients stop smoking, as the plasma levels of erlotinib in these individuals are lower compared to non-smokers.
CONTRAINDICATIONS
Hypersensitivity to erlotinib or to any of the excipients.
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