Erlotinib Erlonat

[Drug Information]

Generic Name: Erlotinib.

Brand Name: Tarceva.

English Name: Erlotinib.

Dosage Form: Tablets.

Specification: 150 mg × 30 tablets/box.

Manufacturer: Natco Pharma.

[Indications]

Indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor sensitive mutations in the epidermal growth factor receptor (EGFR) gene. This includes use as first-line therapy, maintenance therapy, or second-line (or subsequent) therapy following disease progression after at least one prior course of chemotherapy.

Indicated, in combination with gemcitabine, for the treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

[Mechanism of Action]

Erlotinib is a selective inhibitor of the EGFR tyrosine kinase. EGFR is frequently overexpressed or mutated in various cancer cells; such mutations can promote the rapid growth and proliferation of cancer cells. By blocking EGFR activity, Erlotinib inhibits the growth signals within tumor cells, thereby exerting an anti-tumor effect.

[Dosage and Administration]

Non-Small Cell Lung Cancer: The recommended dose is 150 mg/day, taken at least 1 hour before or 2 hours after a meal. Treatment should be continued until disease progression or the occurrence of intolerable toxicity.

Pancreatic Cancer: The recommended dose is 100 mg/day, taken on an empty stomach, typically in combination with gemcitabine.

Dosage Adjustment: If a patient develops new-onset acute or progressive pulmonary symptoms—such as dyspnea, cough, or fever—Erlotinib therapy should be temporarily suspended to allow for diagnostic evaluation. If interstitial lung disease (ILD) is confirmed, Erlotinib should be permanently discontinued, and appropriate treatment should be administered. Diarrhea can typically be managed with loperamide; however, patients experiencing severe diarrhea that is unresponsive to loperamide, or who show signs of dehydration, may require dose reduction or temporary suspension of treatment. Patients experiencing severe skin reactions may also require dose reduction or temporary suspension of treatment. If dose reduction is necessary, the dose of Erlotinib should be decreased by 50 mg increments.

[Adverse Reactions]

Common Adverse Reactions: Include rash, diarrhea, decreased appetite, nausea, fatigue, asthenia, etc. Serious Adverse Reactions: Interstitial lung disease, abnormal liver function, ocular disorders (e.g., conjunctivitis, keratitis, blurred vision, etc.), gastrointestinal bleeding, etc.

[Contraindications]

Contraindicated in patients with known hypersensitivity to erlotinib or any of its components.

Contraindicated in pregnant or breastfeeding women.

[Precautions]

Risk of Interstitial Lung Disease: Use of erlotinib may lead to interstitial lung disease (ILD). If symptoms such as dyspnea, cough, or fever occur, the drug should be discontinued immediately, and medical attention should be sought.

Liver Function Monitoring: Erlotinib may cause abnormal liver function; liver function should be monitored periodically, particularly in patients with a history of liver disease.

Skin Care: As skin rash is a common side effect, patients should maintain proper skin hygiene, avoid excessive sun exposure and irritating products, and use physician-recommended skincare products or ointments if necessary.

Avoid Smoking: Smoking reduces the plasma concentration of erlotinib, thereby diminishing its therapeutic efficacy; patients are advised to abstain from smoking during treatment.

[Use in Specific Populations]

Pregnant Women: Erlotinib may pose a potential teratogenic risk to the fetus; therefore, it is contraindicated in pregnant women.

Breastfeeding Women: Erlotinib may be excreted in breast milk; breastfeeding women should discontinue nursing.

Pediatric Patients: The safety and efficacy of erlotinib in children have not been established; its use is generally not recommended in patients under 18 years of age.

[Drug Interactions]

Concomitant use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole) with erlotinib may increase plasma concentrations of erlotinib. If concomitant use cannot be avoided, the dosage of erlotinib should be reduced immediately upon the appearance of toxic effects.

Concomitant use of strong CYP3A4 inducers (e.g., rifampin, rifapentine, phenytoin) with erlotinib may significantly reduce plasma concentrations of erlotinib; therefore, concomitant use is not recommended.

Concomitant use of P-gp inhibitors (e.g., ritonavir, nelfinavir, ketoconazole) with erlotinib may alter the distribution and/or elimination of erlotinib; caution should be exercised in such cases. [Storage]

Keep tightly closed; store at a temperature not exceeding 25°C. Short-distance transport within the range of 15°C to 30°C is permissible.

[Product Specifications]

Product Name: Tarceva (Erlotinib Hydrochloride Tablets) — Erlotinib Erlonat 150

Common Name: Tarceva

Composition: Erlotinib Hydrochloride

Dosage Form: Tablets

Specification: 30 Tablets

Manufacturer: Natco Pharma (India)

Indications: Erlotinib monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have previously failed at least one chemotherapy regimen.

Clinical studies regarding the use of this product as a first-line treatment for patients with EGFR mutations are currently ongoing. Prescribing physicians are advised to determine the appropriate treatment choice by comprehensively considering the latest research advancements regarding this product and similar agents, as well as the patient's individual condition.

Dosage and Administration: This product must be used under the supervision of a physician experienced in the use of such medications.

The recommended dose of Erlotinib monotherapy for non-small cell lung cancer is 150 mg per day, taken at least 1 hour before or 2 hours after a meal. Treatment should be continued until disease progression occurs or until intolerable toxicity develops. There is no evidence to suggest that continuing treatment after disease progression provides any clinical benefit to the patient.