Erlotinib monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Erlotinib with platinum-based chemotherapy carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
Pancreatic Cancer Erlotinib in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. DOSAGE AND ADMINISTRATION 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. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial. 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 gemcitabine package insert). Treatment should continue until disease progression or unacceptable toxicity occurs. Dose Modifications In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment with Erlotinib should be interrupted pending diagnostic evaluation.
If ILD is diagnosed, Erlotinib should be discontinued and appropriate treatment instituted as necessary. Diarrhea can usually be managed with loperamide. Patients with severe diarrhea who are unresponsive to loperamide or who become dehydrated may require dose reduction or temporary interruption of therapy. Patients with severe skin reactions may also require dose reduction or temporary interruption of therapy. When dose reduction is necessary, the Erlotinib dose should be reduced in 50 mg decrements. In patients who are taking Erlotinib with a strong CYP3A4 inhibitor such as, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, and grapefruit or grapefruit juice, a dose reduction should be considered if severe adverse reactions occur.
Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3 to 4/5. Use of alternative treatments lacking CYP3A4 inducing activity is strongly recommended. If an alternative treatment is unavailable, an increase in the dose of Erlotinib should be considered as tolerated at two week intervals while monitoring the patient`s safety. The maximum dose of Erlotinib studied in combination with rifampicin is 450 mg. If the Erlotinib dose is adjusted upward, the dose will need to be reduced immediately to the indicated starting dose upon discontinuation of rifampicin or other inducers.