Erlotinib Sandoz

Erlotinib Sandoz





Zuellig Pharma
Concise Prescribing Info
Erlotinib HCl
Locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least 1 prior chemotherapy regimen. In combination w/ gemcitabine for the 1st-line treatment of patients w/ locally advanced, unresectable or metastatic pancreatic cancer.
Dosage/Direction for Use
NSCLC 150 mg daily. Pancreatic cancer 100 mg daily in combination w/ gemcitabine. May be reduced in 50 mg steps, if necessary. Smokers w/ NSCLC Max tolerated dose: 300 mg.
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals.
Special Precautions
Assessment of EGFR mutation status. Smokers. Interstitial lung disease. Interrupt treatment in patients who develop acute onset of new &/or progressive unexplained pulmonary symptoms eg, dyspnea, cough & fever. Diarrhea, dehydration, electrolyte imbalance, renal failure; monitor renal function & serum electrolytes including K in patients at risk of dehydration. Severe hepatic dysfunction. Consider periodic liver function testing. Concomitant use w/ antiangiogenics, corticosteroids, NSAIDS, &/or taxane-based chemotherapy, potent inducers & inhibitors of CYP3A4; proton pump inhibitors, H2 antagonist & antacids. Prior history of peptic ulceration or diverticular disease; permanently discontinue if GI perforation develops. Interrupt or discontinue if severe bullous, blistering or exfoliating conditions develops; test for skin infection. History of keratitis, ulcerative keratitis or severe dry eye. Rare hereditary problems of Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Renal & hepatic impairment. Women of childbearing potential should use contraceptive methods during & at least 2 wk after treatment. Pregnancy & lactation.
Adverse Reactions
Infection; anorexia, decreased wt; keratoconjunctivitis sicca, conjunctivitis; dyspnea, cough; diarrhea, nausea, vomiting, stomatitis, abdominal pain, dyspepsia, flatulence; rash, pruritus, dry skin, alopecia; fatigue, pyrexia, rigors; depression; neuropathy, headache. Liver function test abnormalities; epistaxis, serious interstitial lung disease; GI bleeding; paronychia, folliculitis, acne/dermatitis acneiform, skin fissures; renal insufficiency.
Drug Interactions
Increased exposure w/ potent CYP1A2 inhibitors eg, ciprofloxacin, fluvoxamine. Decrease oral bioavailability of midazolam. Decreased metabolism & increased plasma conc w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole), protease inhibitors, erythromycin or clarithromycin. Increased metabolism & decreased plasma conc w/ potent CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, barbiturates or St. John's Wort (Hypericum perforatum). Increased INR & bleeding events w/ coumarin-derived anticoagulants eg, warfarin. Potential increase for statin-induced myopathy (eg, rhabdomyolysis) w/ statins. Altered distribution &/or elimination w/ Pgp inhibitors eg, cyclosporine, verapamil. Decreased exposure & max conc w/ proton pump inhibitors (eg, omeprazole), H2-receptor antagonist (eg, ranitidine). Increased conc by capecitabine. Proteasome inhibitors (eg, bortezomib).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB02 - erlotinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Erlotinib Sandoz FC tab 150 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in