Erlocent 100: Each tablet contains Erlotinib Hydrochloride INN equivalent to Erlotinib
Erlocent 150: Each tablet contains Erlotinib Hydrochloride INN equivalent to Erlotinib
Non-small cell lung cancer (NSCLC)
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations receiving first-line, maintenance or second or greater line treatment after progression following at least one prior chemotherapy regimen
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with Gemcitabine
Limitations of Use
Erlotinib is not recommended for use in combination with platinum-based chemotherapy
Safety and efficacy of Erlotinib have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution
Pancreatic cancer: The recommended daily dose of Erlotinib for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine.
Erlotinib should be taken on an empty stomach, i.e., at least one hour before or two hours after the ingestion of food. Treatment should be continued until disease progression or unacceptable toxicity occurs.
Renal Failure: Renal function and electrolytes should be monitored, particularly in patients at risk of dehydration. Erlotinib should be withheld for severe renal toxicity
Hepatotoxicity with or without hepatic impairment including hepatic failure and hepatorenal syndrome: Periodic liver testing should be monitored. Erlotinib should be withheld or discontinued for severe or worsening liver tests
Gastrointestinal perforations: Erlotinib should be discontinued
Bullous and exfoliative skin disorders: Erlotinib should be discontinued
Myocardial infarction (MI)/ischemia: The risk of MI is increased in patients with pancreatic cancer
Cerebrovascular accident (CVA): The risk of CVA is increased in patients with pancreatic cancer
Microangiopathic hemolytic anemia (MAHA): The risk of MAHA is increased in patients with pancreatic cancer
Ocular disorders: Erlotinib should be discontinued for corneal perforation, ulceration or persistent severe keratitis
Hemorrhage in patients taking Warfarin: INR should be monitored in patients taking warfarin or other coumarin-derivative anticoagulants
Embryo-Fetal Toxicity: Can cause fetal harm. Females should be advised of reproductive potential of potential risk to the fetus and to use highly effective contraception
Pregnancy Category D. Erlotinib can cause fetal harm when administered to a pregnant woman. If Erlotinib is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
It is not known whether Erlotinib is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Erlotinib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The safety and effectiveness of Erlotinib in pediatric patients have not been established.
Use in Females
Patients should be advised on pregnancy planning and prevention. Females patients should be advised of reproductive potential to use highly effective contraception during treatment with Erlotinib, and for at least 2 weeks after the last dose of Erlotinib. Females patients should be advised to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking Erlotinib.
Patients with hepatic impairment (total bilirubin > upper limit of normal (ULN) or Child-Pugh A, B and C) should be closely monitored during therapy with Erlotinib. Treatment with Erlotinib should be used with extra caution in patients with total bilirubin > 3 x ULN
Less than 9% of a single dose is excreted in the urine. No clinical studies have been conducted in patients with compromised renal function.
CYP3A4 inducers decrease Erlotinib plasma concentrations
Drugs affecting gastric pH decrease Erlotinib plasma concentrations
Cigarette smoking decreases Erlotinib plasma concentrations
Erlocent 150: Each box contains 1 blister strip of 10 tablets.