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Erlox

Erlox

erlotinib

Manufacturer:

Shandong Confucius Pharmaceutical

Distributor:

Goodfellow
Concise Prescribing Info
Contents
Erlotinib
Indications/Uses
1st-line treatment for locally advanced NSCLC w/ EGFR activating mutations. Switch maintenance treatment in patients w/ locally advanced or metastatic NSCLC w/ EGFR activating mutations & stable disease after 1st-line chemotherapy. Locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. When other treatment options are not considered suitable in patients w/ tumors w/o EGFR activating mutations. Metastatic pancreatic cancer in combination w/ gemcitabine.
Dosage/Direction for Use
NSCLC 150 mg at least 1 or 2 hr after ingestion of food. Pancreatic cancer 100 mg at least 1 or 2 hr after ingestion of food in combination w/ gemcitabine. Reduce dose in 50 mg steps if necessary.
Administration
Should be taken with food.
Contraindications
Special Precautions
Assess EGFR mutation status. Current smokers are advised to stop smoking. Interrupt therapy in patients who develop acute onset of new &/or progressive unexplained pulmonary symptoms eg, dyspnoea, cough & fever; in the event of severe or persistent diarrhoea, nausea, anorexia or vomiting associated w/ dehydration. Carefully monitor for the possibility to develop ILD-like toxicity w/ gemcitabine. Monitor renal function & serum electrolytes including K in patients at risk of dehydration. Consider periodic LFT in patients w/ preexisting liver disease or concomitant hepatotoxic medications. Increased risk of developing GI perforation w/ concomitant use of anti-angiogenic agents, corticosteroids, NSAIDs, &/or taxane based chemotherapy, or those who have prior history of peptic ulceration or diverticular disease; permanently discontinue in patients who develop GI perforation. Interrupt or discontinue treatment if severe bullous, blistering & exfoliative skin conditions, including SJS/TEN develops. History of keratitis, ulcerative keratitis or severe dry eye. Avoid concomitant treatment w/ potent CYP3A4 inducers/inhibitors; PPIs, H2 antagonists & antacids. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ severe hepatic dysfunction. Childn <18 yr.
Adverse Reactions
Rash; diarrhea. Infection; anorexia, wt decreased; keratoconjunctivitis sicca, conjunctivitis; depression; neuropathy, headache; dyspnoea, cough; nausea, vomiting, stomatitis, abdominal pain, dyspepsia, flatulence; pruritus, dry skin, alopecia; fatigue, pyrexia, rigors. Keratitis; epistaxis; GI bleeding; paronychia, folliculitis, acne/dermatitis acneiform, skin fissures; renal insufficiency.
Drug Interactions
Increased AUC w/ ciprofloxacin or potent CYP1A2 inhibitors (eg, fluvoxamine). Decreased oral bioavailability of midazolam. Decreased metabolism & increased plasma conc w/ potent CYP3A4 inhibitors eg, azole antifungals (ie, ketoconazole, itraconazole, voriconazole) PIs, erythromycin or clarithromycin. Increased metabolism & decreased plasma conc w/ 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 for statin-induced myopathy, including rhabdomyolysis w/ statins. Reduced AUCinf, Cmax & plasma conc in smokers Altered distribution &/or elimination w/ P-gp inhibitors eg, cyclosporine & verapamil. May impair absorption w/ antacids. Increased platinum conc. May increase conc w/ capecitabine. May influence effect w/ PIs including 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
Erlox FC tab 150 mg
Packing/Price
35's
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