Tarlonib Dosage/Direction for Use

Standard Dosage: Non-Small Cell Lung Cancer: The recommended daily dose of erlotinib is 150 mg taken at least one hour before or two hours after the ingestion of food.
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 label of gemcitabine for the pancreatic cancer indication).
Special Dosage Instructions: Concomitant use of CYP3A4 substrates and modulators may require dose adjustment (see Interactions).
When dose adjustment is necessary, it is recommended to reduce in 50 mg steps (see Precautions and Interactions).
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. Safety and efficacy have not been reported in patients with severe hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics: Pharmacokinetics in special populations under Actions).
Renal impairment: The safety and efficacy of erlotinib has not been studied in patients with renal impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Pediatric use: The safety and efficacy of erlotinib has not been studied in patients under the age of 18 years.
Smokers: Cigarette smoking has been reported to reduce erlotinib exposure by 50-60%. The maximum tolerated dose of erlotinib in NSCLC patients who currently smoke cigarettes was reported as 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: Pharmacokinetics in Special Populations under Actions).