Tarceva - Tablet Erlotinib - 100mg 1 Tablet(s) / Tablet Roche Bangladesh Pharmaceutical Introduction: Tarceva is used in the treatment of non-small cell lung cancer and pancreatic cancer. Tarceva should be taken on an empty stomach or should be taken one hour before or 2 hour after meal. You should continue to take it as long as your doctor advises it. The duration of treatment varies according to your needs and response to treatment. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the... Uses of Tarceva: Non-small cell lung cancerPancreatic cancer Side effects of Tarceva: Abdominal painBone painBreathlessnessConstipationCoughDiarrheaFatigueFeverInfectionMuscle painNauseaRashStomatitis (Inflammation of the mouth)VomitingWeight loss How to use Tarceva: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tarceva is to be taken empty stomach. How Tarceva works: Tarceva is an anti-cancer medication. Epidermal growth factor receptors (EGFR) are expressed on the lung cancer cell surfaces that modulate their growth. This medicine works by binding the chemical messenger, EGFR, hence, inhibits the cancer signaling pathways mediated by EGFR. This is how it restricts further growth of the cancer cells. What if you forget to take Tarceva?: If you miss a dose of Tarceva, skip it and continue with your normal schedule. Do not double the dose. Indication: Small cell lung cancer, Pancreatic cancer Administration: Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before or 2 hr after meals. Adult Dose: Oral Locally advanced or metastatic non-small cell lung carcinoma Adult: 150 mg once daily until disease progression or unacceptable toxicity. Reduce dose in decrements of 50 mg when necessary. Locally advanced, unresectable or metastatic pancreatic cancer Adult: As 1st-line treatment with gemcitabine: 100 mg once daily, reduce dose in decrements of 50 mg when necessary. Child Dose: Safety and efficacy not established Contraindication: Hypersensitivity. Mode of Action: Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR/HER1) tyrosine kinase inhibitor. It reversibly inhibits the kinase activity of EGFR, preventing autophosphorylation of tyrosine residues associated w/ the receptor, thereby inhibiting further downstream signaling and resulting in cell death. Precaution: Pregnancy and lactation. Interrupt Erlotinib therapy if patient develops unexplained pulmonary symptoms e.g. dyspnoea, cough, fever; discontinue therapy if interstitial lung disease is diagnosed. Monitor liver functions periodically; extreme caution is needed if total bilirubin is 3x >ULN; close monitoring is required in patients with hepatic impairment. Interrupt/discontinue therapy if severe changes in liver functions (doubling of total bilirubin and/or tripling of transaminases) occur. Interrupt therapy in the event of dehydration especially in patients with predisposing factors to renal failure. Monitor renal function and serum electrolytes in patients at risk of dehydration. Interrupt or discontinue therapy if patient develops severe... Side Effect: >10% Rash (75-76%),Anorexia (52-69%),Diarrhea (54-55%),Fatigue (52-79%),Nausea (33-40%),Infection (39%),Vomiting (23-25%),Dyspnea (24%),Stomatitis (17-19%),Cough (16%),Pruritus (13%),Conjunctivitis (12%),Dry skin (12%),Keratoconjunctivitis sicca (12%),Abdominal pain (11%) 1-10% Elevated LFT's (grade 2),Acne,Paronychia,Weight loss,Pneumonitis pulmonary infiltrate,Pulmonary fibrosis <1% Interstitial lung disease-like events Pregnancy Category Note: Pregnancy Based on animal data and its mechanism of action, erlotinib can cause fetal harm when administered to a pregnant woman Advise females of reproductive potential to use effective contraception during treatment and for 1 month after the last dose Lactation No data exist on the presence of erlotinib in human milk, or the effects of erlotinib on the breastfed infant or on milk production Because of the potential for serious adverse reactions in breastfed infants, including interstitial lung disease, hepatotoxicity, bullous and exfoliative skin disorders, microangiopathic hemolytic anemia, with thrombocytopenia, ocular disorders, and diarrhea Advise a lactating woman not... Interaction: Increased serum levels w/ potent CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, atazanavir). CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital) may reduce exposure of erlotinib. Increased serum levels w/ potent inhibitors of CYP1A2 (e.g. ciprofloxacin) or capecitabine. Use w/ P-glycoprotein inhibitors (e.g. ciclosporin, verapamil) may cause altered distribution or elimination of erlotinib. Drugs that increase the pH of the GI tract (e.g. antacids, H2-receptor antagonists, or PPIs) may reduce the solubility of erlotinib thus lowering its bioavailability. Concomitant use w/ warfarin or other coumarin derivates may increase INR and bleeding events.