Erlotinib Sandoz

Erlotinib Sandoz

erlotinib

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Erlotinib HCl
Indications/Uses
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.
Administration
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.
Presentation/Packing
Form
Erlotinib Sandoz FC tab 150 mg
Packing/Price
30's
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