TLPH Geifoni Gefitinib

Product Information

• Product name: Geifoni Gefitinib as shown on package
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Gefitinib
• Current strength: as shown on package
• SKU: AM-ITEM-14
• Site category: first-generation EGFR-TKI, general medicines

Product Summary

Geifoni Gefitinib as shown on package is an AISTIKA-listed product supplied by Laos TLPH Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Gefitinib is the active ingredient used for this product page. Public prescribing information for Gefitinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

The epidermal growth factor receptor (EGFR) is expressed on the cell surface of both normal and cancer cells and plays a role in the processes of cell growth and proliferation. Some EGFR activating mutations (exon 19 deletion or exon 21 point mutation L858R) within NSCLC cells have been identified as contributing to the promotion of tumor cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.

Reference Indications

Gefitinib tablets are indicated for the first-line 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 as detected by an FDA-approved test . Limitation of Use: Safety and efficacy of Gefitinib tablets have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations . Gefitinib tablets are a tyrosine kinase inhibitor indicated for the first-line 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 as detected by an FDA-approved test.

Reference Dosage and Administration

Recommended dose is 250 mg orally, once daily with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Interstitial lung disease (ILD): ILD occurred in patients taking Gefitinib tablets. Withhold Gefitinib tablets for worsening of respiratory symptoms. Discontinue Gefitinib tablets if ILD is confirmed. ( 2.4 , 5.1 ) Hepatotoxicity: Obtain periodic liver function testing. Withhold Gefitinib tablets for Grade 2 or higher for ALT and/or AST elevations. Discontinue for severe hepatic impairment. ( 2.4 , 5.2 ) Gastrointestinal perforation: Discontinue Gefitinib tablets for gastrointestinal perforation. ( 2.4 , 5.3 ) Diarrhea: Withhold Gefitinib tablets for Grade 3 or higher diarrhea. ( 2.4 , 5.4 ) Ocular Disorders including Keratitis: Withhold Gefitinib tablets for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis.

Common Adverse Reactions and Monitoring

The following adverse drug reactions are discussed in more detail in other sections of the labeling: Interstitial Lung Disease Hepatotoxicity Gastrointestinal Perforation Severe or Persistent Diarrhea Ocular Disorders including Keratitis Bullous and Exfoliative Skin Disorders The most commonly reported adverse drug reactions (ADRs), reported in more than 20% of the patients and greater than placebo were skin reactions and diarrhea. The safety of Gefitinib tablets is based on the data from 2462 patients with NSCLC who received Gefitinib tablets 250 mg daily monotherapy in three randomized clinical studies (Study 2, Study 3 and Study 4).

Drug Interactions and Special Populations

CYP3A4 Inducer: Increase Gefitinib tablets to 500 mg daily in patients receiving a strong CYP3A4 inducer. Drugs Affecting Gastric pH: Avoid concomitant use of Gefitinib tablets with proton pump inhibitors, if possible. Hemorrhage in patients taking warfarin: Monitor changes in prothrombin time or INR. Increase Gefitinib tablets to 500 mg daily in patients receiving a strong CYP3A4 inducer (e.g., rifampicin, phenytoin, or tricyclic antidepressant) and resume Gefitinib tablets at 250 mg 7 days after discontinuation of the strong inducer . CYP3A4 Inhibitor Drugs that are strong inhibitors of CYP3A4 (e.g., ketoconazole and itraconazole) decrease Gefitinib metabolism and increase Gefitinib plasma concentrations.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Gefitinib public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.