Gefikin 250 Tablet : Each film coated tablet contains Gefitinib BP 250 mg.
The mechanism of the clinical antitumor action of Gefitinib is not fully characterized. Gefitinib inhibits the intracellular phosphorylation of numerous tyrosine kinases associated with transmembrane cell surface receptors, including the tyrosine kinases associated with the epidermal growth factor receptor (EGFR-TK). EGFR is expressed on the cell surface of many normal cells and cancer cells.
Gefitinib is 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.
The recommended dose of Gefitinib is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity. Do not take a missed dose within 12 hours of the next dose. Administration to patients who have difficulty swallowing solid tablet, immerse Gefitinib tablets in 120/140ml of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube.
1. Interstitial lung disease (ILD): ILD occurred in patients taking Gefitinib. Should withheld Gefitinib for worsening of respiratory symptoms. Need to discontinue Gefitinib if ILD is confirmed.
2. Hepatotoxicity: Should withheld Gefitinib for Grade 2 or higher for ALT and/or AST elevations. Should discontinue for severe hepatic impairment.
3. Gastrointestinal perforation: Discontinue Gefitinib for gastrointestinal perforation.
4. Diarrhea: Withhold Gefitinib for Grade 3 or higher diarrhea.
5. Ocular Disorders including Keratitis: For signs and symptoms of severe or worsening ocular disorders including keratitis Gefitinib should be withheld.
6. Embryo-fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
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Gefikin 250 Tablet: Each HDPE container of Gefikin 250 contains 30 tablets, a silica gel desiccant and polyester coil with a child resistant closure.
The acute toxicity of Gefitinib up to 500 mg in clinical studies has been low. Adverse reactions associated with overdose should be treated symptomatically; in particular, severe diarrhea should be managed appropriately.
Do not store above 30⁰ C. Protect from light. Keep out of reach of children.