International Med
Concise Prescribing Info
Monotherapy for maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ stable disease after 4 cycles of platinum-based chemotherapy. Treatment of patients w/ locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. In combination w/ gemcitabine for treatment of patients w/ metastatic pancreatic cancer.
Dosage/Direction for Use
NSCLC 150 mg daily. Perform EGFR mutation testing prior to initiation in chemo-naïve patients w/ advanced or metastatic NSCLC. Pancreatic cancer 100 mg daily in combination w/ gemcitabine.
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals.
Special Precautions
Cases of interstitial lung disease-like events, especially w/ concomitant gemcitabine. Risk of diarrhoea or dehydration; GI perforation; bullous, blistering & exfoliative skin conditions. Monitor renal function & serum electrolytes including K in patients at risk of dehydration. Perform periodic liver function test in patients w/ pre-existing liver disease or concomitantly taking hepatotoxic medications. Patients presenting w/ signs & symptoms suggestive of keratitis should be referred promptly to an ophthalmology specialist. Caution in patients w/ history of keratitis, ulcerative keratitis or severe dry eye. Current smokers should be advised to stop smoking. Avoid concomitant use of potent CYP3A4 inducers; proton pump inhibitors, H2 antagonists & antacids. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ severe renal impairment. Pregnancy & lactation. Women of childbearing potential must be advised to avoid pregnancy while on treatment. Not recommended in patients <18 yr.
Adverse Reactions
Rash, diarrhoea, fatigue, cough, infection, stomatitis. NSCLC: Anorexia, dyspnoea, nausea, vomiting, pruritus, dry skin, keratoconjunctivitis sicca, conjunctivitis, abdominal pain. Pancreatic cancer: Wt decreased, depression, headache, neuropathy, dyspepsia, flatulence, alopecia, pyrexia, rigors.
Drug Interactions
Increased exposure w/ potent CYP1A2 inhibitor (eg, fluvoxamine). Decreased oral bioavailability of midazolam. Potential interaction w/ substrates of UGT1A1 & medicinal products exclusively cleared by this pathway. Increased plasma conc w/ potent CYP3A4 inhibitors eg, azole antifungals, PIs, erythromycin, clarithromycin. Decreased plasma conc w/ potent CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, barbiturates or St. John's Wort. Increased INR & bleeding events w/ coumarin-derived anticoagulants including warfarin. Increased potential for statin-induced myopathy, including rhabdomyolysis, w/ combination of Alvoceva & a statin. Reduced plasma conc in smokers. Altered distribution &/or altered elimination w/ P-gp inhibitors eg, cyclosporine, verapamil. Altered solubility w/ medicinal products that alter pH of the upper GI tract (eg, proton pump inhibitor, H2-receptor antagonist). Increased platinum conc w/ carboplatin & paclitaxel. Increased conc w/ capecitabine. Proteasome inhibitors including bortezomib may be expected to influence effect of EGFR inhibitors including erlotinib.
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
3 × 10's
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