Uses of Erlonix: - Non-small cell lung cancer - Pancreatic cancer Small cell lung cancer, Pancreatic cancer Hypersensitivity.

Targeted Cancer Therapy

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.

How to use Erlotinib: 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. Erlotinib is to be taken empty stomach. 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

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.

Hypersensitivity.

Common - Abdominal pain - Bone pain - Breathlessness - Constipation - Cough - Diarrhea - Fatigue - Fever - Infection - Muscle pain - Nausea - Rash - Stomatitis (Inflammation of the mouth) - Vomiting - Weight loss >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

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

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 bullous and exfoliative skin disorders; eye pain or other acute/worsening ocular disorders. If patient develops GI perforation, discontinue therapy permanently. Patients with CV disorders. Monitor prothrombin time/INR in patients taking warfarin or other coumarin-derivative anticoagulants. Lactation: excretion in milk unknown/not recommended

Single oral doses of Erlotinib up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent Erlotinib in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse reactions, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose. In case of suspected overdose, Erlotinib should be withheld and symptomatic treatment instituted.

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.

Targeted Cancer Therapy

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.

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 to breastfeed during treatment and for 2 weeks after the final dose