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Geftibenz 250 Tablets

Generic Name- Gefitinib

Drug Class- Antineoplastic agent

Gefitinib is a selective small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (EGFR TKI) used for the treatment of adults with non small cell lung cancer with activating mutations of EGFR tyrosine kinase. It acts by inhibiting EGFR, an enzyme that regulates intracellular signaling pathways essential for the proliferation and survival of cancer cells.

Category

Product Description

Geftibenz 250 (Gefitinib) tablets is an orally available anticancer drug.

Indications and Usage

  • Gefitinib is indicated for first line treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies

Limitation of Use:

  • The efficacy and safety of gefitinib is not established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations

Dosage and Administration

  • Recommended dose in NSCLC: 250 mg orally, once daily with or without food

Dosage Forms and Strengths

  • Supplied as tablets for oral administration
  • Available in 250mg strength

Clinical Efficacy

  • Effective and generally well-tolerated first- or subsequent-line treatment option for patients with NSCLC and activating EGFR mutations who have not received an EGFR TKI previously2
  • Prolong progression-free survival (PFS), improve objective response rates and/or health-related quality of life parameters in patients with activating EGFR mutations2
  • Improves disease-related symptoms and induces radiographic tumor regression in patients with NSCLC persisting after chemotherapy4

Adverse Reactions

  • The most commonly reported adverse events reported in patients receiving gefitinib are skin reactions and diarrhea

Contraindications

  • None

Special Precautions

  • Gefitinib can cause interstitial lung disease (ILD) , so withhold treatment if worsening of respiratory symptoms occurs and discontinue gefitinib, if ILD is confirmed
  • Monitor periodic liver function to determine the risk of hepatotoxicity and if severe hepatic impairment occurs, discontinue treatment
  • Discontinue gefitinib use in patients who develop gastrointestinal perforation
  • Withhold treatment in patients developing Grade 3 or higher diarrhea, severe or worsening ocular disorders including keratitis and Grade 3 or higher skin reactions or exfoliative conditions
  • Avoid concomitant use of gefitinib with proton pump inhibitors
  • Monitor adverse reactions in patients receiving gefitinib along with CYP3A4 Inhibitor
  • Consider an increased dose of gefitinib up to 500mg daily in patients receiving a strong CYP3A4 inducer
  • Patients receiving warfarin should be monitor carefully before using gefitinib, as concomitant use can result in adverse events such as hemorrhage
  • Advise women of child bearing potential to use effective contraception to avoid pregnancy as gefitinib can cause fetal harm
  • Discontinue breast feeding while receiving treatment with gefitinib
Gefitinib 250 Tablets Brand Name Geftibenz | Manufacturer-Admac