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Erlotinib (trade names include Tarceva, Erlocip, Erlonat, Zyceva) is an anti-cancer medication from protein kinase inhibitors pharmacological group. This medicine is used for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. It works as an epidermal growth factor receptor inhibitor (EGFR inhibitor).
Cabozantinib (Cabometyx, Cometriq)
Everolimus (Zortress, Certican)
Lapatinib (Tykerb, Tyverb)
Lenvatinib (Lenvima, Lenvanix)
Pharmacological and medical categories:
Anti cancer drugs
Epidermal growth factor receptor tyrosine kinase (EGFR) inhibitors
NSCLC treatment medications
Pancreatic cancer therapy
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XE - Protein kinase inhibitors
L01XE03 - Erlotinib
Malignant neoplasm of pancreas - C25
Malignant neoplasm of bronchus and lung - C34
Indications and usage:
Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
Dosage and administration:
The dose for NSCLC is 150 mg/day.
The dose for pancreatic cancer is 100 mg/day.
All doses of Tarceva should be taken on an empty stomach at least one hour before or two hours after food.
Reduce in 50 mg decrements, when necessary.
Dosage forms and strengths:
Tarceva (Erlotinib Hydrochloride) film-coated tablets for oral use: 25 mg, 100 mg, and 150 mg.
Withhold erlotinib in patients with an overdose or suspected overdose and institute symptomatic treatment.
Warnings and precautions:
Interstitial lung disease (ILD): Occurs in 1.1% of patients. Withhold Tarceva for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue Erlotinib if ILD is diagnosed.
Renal failure: Monitor renal function and electrolytes, particularly in patients at risk of dehydration. Withhold Tarceva for severe renaltoxicity.
Hepatotoxicity: Occurs with or without hepatic impairment, including hepatic failure and hepatorenal syndrome: Monitor periodic liver testing. Withhold or discontinue Tarceva (Erlotinib Hydrochloride) for severe or worsening liver tests.
Gastrointestinal perforations: Discontinue this drug.
Bullous and exfoliative skin disorders: Discontinue Tarceva.
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: Discontinue this medication for corneal perforation, ulceration or persistent severe keratitis.
Hemorrhage in patients taking warfarin: Regularly monitor INR in patients taking warfarin or other coumarin-derivative anticoagulants.
Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
CYP3A4 inhibitors or a combined CYP3A4 and CYP1A2 inhibitor increase erlotinib plasma concentrations. Avoid concomitant use. If not possible, reduce Tarceva dose.
CYP3A4 inducers decrease erlotinib plasma concentrations. Avoid concomitant use. If not possible, increase Erlotinib dose.
Cigarette smoking and CYP1A2 inducers decrease erlotinib plasma concentrations. Avoid concomitant use. If not possible, increase Tarceva dose.
Drugs that increase gastric pH decrease erlotinib plasma concentrations. For proton pump inhibitors avoid concomitant use if possible. For H-2 receptor antagonists, take this medicine 10 hours after H-2 receptor antagonist dosing. For use with antacids, separate dosing by several hours.
Use in specific populations:
Lactation: Do not breastfeed.
Adverse reactions, side effects:
The most common adverse reactions (>20%) in maintenance treatment are rash-like events and diarrhea.
The most common adverse reactions (>20%) in 2nd line NSCLC are rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, infection and vomiting.
The most common adverse reactions (>20%) in pancreatic cancer are fatigue, rash, nausea, anorexia, diarrhea, abdominal pain, vomiting, weight decrease, infection, edema, pyrexia, constipation, bone pain, dyspnea, stomatitis and myalgia.
C - Australia (Risk cannot be ruled out)
N - United States (Not classified yet)
Salts and other forms:
Synonyms, international and chemical names:
Brands, generics, trade names:
Erlocip - Cipla
Erlonat - Natco Pharma
Erlotinib - Mylan
Tarceva - Roche, Astellas Pharma, Genentech, OSI Pharmaceuticals, Schwarz Pharma
Zyceva - Zydus pharmaceuticals
Erlotinib main article on Wikipedia: https://en.wikipedia.org/wiki/Erlotinib
Erlotinib compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Erlotinib
Erlotinib Hydrochloride compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Erlotinib-hydrochloride
Erlotinib on DrugBank: https://www.drugbank.ca/drugs/DB00530
Erlotinib Hydrochloride on DrugBank: https://www.drugbank.ca/salts/DBSALT000064
Erlotinib FAQ on MedlinePlus (revised 03/15/2017): https://medlineplus.gov/druginfo/meds/a605008.html
Tarceva (Erlotinib Hydrochloride) tablets drug label info on DailyMed (revised December 12, 2018): https://dailymed.nlm.nih.gov/dailymed/lookup...
Erlotinib Hydrochloride film-coated tablets drug label info on DailyMed (revised October 25, 2019): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Erlotinib for sale on Pharma Doctor (revised September 2021): https://pharma-doctor.com/erlotinib.html
Tarceva (Erlotinib Hydrochloride) oral tablets official prescribing and patient counseling information from the U.S. FDA (revised 10/2016): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Tarceva (Erlotinib Hydrochloride) tablets for oral use prescribing and patient information from Genentech pharmaceutical company (revised 10/2016): https://www.gene.com/download/pdf/tarceva_prescribing.pdf
Tarceva (Erlotinib) tablets official website: https://www.tarceva.com/patient/
Tarceva (Erlotinib HCl) 25 mg, 100 mg, 150 mg film-coated tablets package information leaflet on Medicines.org.uk (revised November 2018): https://www.medicines.org.uk/emc/files/pil.8845.pdf
Erlocip (Erlotinib, Tarceva generic) 100 mg and 150 mg tablets prescribing information from Cipla pharmaceutical company (revised July 2015): https://www.ciplamed.com/content/erlocip-tablets
Revised: September 2021
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