Zuellig Pharma
Concise Prescribing Info
Erlotinib HCl
1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ EGFR activating mutations. Switch maintenance treatment in patients w/ locally advanced or NSCLC w/ EGFR activating mutations & stable disease after 1st-line chemotherapy. Patients w/ locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. In combination w/ gemcitabine, for patients w/ metastatic pancreatic cancer.
Dosage/Direction for Use
NSCLC 150 mg once daily. Smokers Max dose: 300 mg once daily. Pancreatic cancer In combination w/ gemcitabine: 100 mg once daily. When dose adjustment is necessary, the dose should be reduced in 50 mg steps.
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals.
Special Precautions
Perform EGFR  mutation testing prior to initiation of therapy in chemo-naïve patients w/ advanced or metastatic NSCLC. Smokers are advised to stop smoking. Discontinue use in patients experiencing pulmonary toxicity; if interstitial lung disease is diagnosed. Interrupt or discontinue use in patients experiencing pulmonary toxicity; if severe bullous, blistering or exfoliative disorders occur; ulcerative keratitis is confirmed. Monitor renal function & serum electrolytes including K in patients at risk of dehydration; interrupt treatment in dehydrated patients. Periodic liver function testing should be considered. History of ulcerative keratitis or severe dry eye. Increased risk of perforation in patients w/ history of PUD or diverticulitis & receiving concomitant therapy w/ anti-angiogenesis drugs, corticosteroids, NSAIDs, &/or taxane-based chemotherapy. Permanently discontinue use if perforation occurs. Patients w/ history of keratitis, ulcerative keratitis or severe dry eye. Avoid concomitant use w/ potent CYP3A4 inducers & inhibitors; proton pump inhibitors, H2 antagonists & antacids. Antacids should be taken at least 4 hr before or 2 hr after the daily treatment dose. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ severe hepatic & renal dysfunction. Women of childbearing potential should avoid pregnancy during therapy & use adequate contraceptive methods during & at least 2 wk after completing therapy. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infection; anorexia; keratoconjunctivitis sicca, conjunctivitis; dyspnoea, cough; diarrhea, nausea, vomiting, stomatitis, abdominal pain; rash, pruritus, dry skin; fatigue.
Drug Interactions
Increased exposure w/ ciprofloxacin. Decreased oral bioavailability of midazolam. Increased serum conc of bilirubin w/ drugs that are UGT1A1 substrates. Decreased metabolism & increased plasma conc w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, PIs, erythromycin or clarithromycin. Increased metabolism & decrease plasma conc by potent CYP3A4 inducers (eg, rifampicin). Reduced exposure w/ phenytoin, carbamazepine, barbiturates or St. John's wort (Hypericum perforatum). Increased INR & bleeding events w/ coumarin-derived anticoagulants including warfarin. May increase potential statin-induced myopathy, including rhabdomyolysis. May lead to altered distribution &/or altered elimination w/ P-gp inhibitors eg, cyclosporine & verapamil. Solubility & bioavailability may be altered by drugs that alter the pH of upper GI tract. Decreased exposure & Cmax w/ omeprazole & ranitidine. Increased total platinum AUC0-48 w/ carboplatin/paclitaxel. May increase conc w/ capecitabine. Effect may be influenced by proteasome inhibitors (eg, bortezomib).
ATC Classification
L01EB02 - erlotinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Alvoceva FC tab 150 mg
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