ERLOTINIB HCL (Generic for TARCEVA)

Erlotinib 150mg, Oral tablet

Grapefruit juice

· Severity: Major

· Notes for Consumers: Avoid Grapefruit or Grapefruit juice while receiving Erlotinib treatment. Side effects from Erlotinib may get worse if you take Grapefruit Juice. Contact your health care provider if you experience rash, diarrhea, fatigue, breathing problems, nausea, vomiting, or other unusual effects.

· Notes for Professionals: Have patients avoid grapefruit or grapefruit juice during erlotinib treatment due to the increased risk of erlotinib-related adverse reactions. Erlotinib is a CYP3A4 substrate and grapefruit juice is a strong CYP3A4 inhibitor. Coadministration with another strong CYP3A4 inhibitor increased erlotinib exposure by 67%.

Erlotinib 150mg, Oral tablet

Tobacco

· Severity: Major

· Notes for Consumers: Do not smoke while taking Erlotinib. Talk to your health care professiona if you are a smoker. Smoking may decrease erlotinib levels, causing your cancer therapy to not work as well for you. If you have been smoking and then stop smoking, you may need careful monitoring, Inform your prescriber of any change in smoking status. If you stop smoking, erlotinib levels can increase or you may experience side effects. An erlotinib dose adjustment may be necessary in some patients who smoke or who quit smoking; do not adjust the dose by yourself.

· Notes for Professionals: Advise patients to avoid tobacco smoking while taking erlotinib if possible. Patients should communicate to their prescriber any changes in smoking status during erlotinib treatment. If the patient continues to smoke or begins to smoke and concomitant use is unavoidable, increase the dose of erlotinib by 50 mg increments at 2-week intervals to a maximum of 300 mg/day. Immediately reduce the dose of erlotinib to the recommended dose upon cessation of smoking. Erlotinib is primarily metabolized by CYP3A4, and to a lesser extent by CYP1A2. Tobacco smoke is a CYP1A2 inducer. In a single-dose pharmacokinetics trial in healthy volunteers, cigarette smoking (moderate CYP1A2 inducer) decreased the AUC of erlotinib by 64% (95% CI, 46% to 76%) in current smokers compared with former/never smokers. Steady-state trough concentrations of erlotinib were approximately 2-fold less in current smokers compared with former/never smokers in a separate study of patients with NSCLC.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>